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investek
Posted on: Dec 13 2019, 09:49 PM


Group: Member
Posts: 259

So why is Wolgen still/back in Oz?

It’s been over 3 weeks, nearly a month since the AGM, I wonder if he’s been in Melb the whole time?
My gut feel is that he is riding the local team hard to get the TGA submission in ASAP (note: I have no basis for this guess, pure speculation).

Also I’ve been thinking about the Investor Relations Manager position/recruitment. I think we all agree Mr Bull is a pretty awesome name for someone heading this function however given Wolgen’s penchant for ROI, constraining resources, and pushing the existing team to learn on-the-job/adapt to new roles, I’m starting to question the hire. I know many on this board have attempted to make contact with him and got little to no response. There doesn’t seem to be much/any shift in institutional interest. Still no analyst coverage from the big houses, UBS, credit suisse, DB, Mac Bank etc. Plus short interest has increased out of sight since he came on board.

So what return/value is Wolgen looking for from this new focus on investor relations? Sphere seem to be snubbed, Moelis is being paid from the ASX (thx Polyphemus), large and long term retail holders are being snubbed and we’ve heard nothing about an upcoming NASDAQ listing.

Thoughts anyone?
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investek
Posted on: Dec 10 2019, 02:01 AM


Group: Member
Posts: 259

23 October 2014
EMA/CHMP/709396/2014 Rev.1
Committee for Medicinal Products for Human Use (CHMP)
Assessment report
SCENESSE
International non-proprietary name: afamelanotide Procedure No. EMEA/H/C/002548/0000

https://www.ema.europa.eu/en/documents/asse...t-report_en.pdf
p46

Not sure if the FDA docs had any more recent info on trial CUV011...
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investek
Posted on: Dec 10 2019, 01:12 AM


Group: Member
Posts: 259

I’ve also been patiently waiting for the results of this trial (CUV011) and it is my personal belief that Wolgen is being very strategic with the duration of the trial/release of the full results.

I had a quick look back through a few of the past AGM presentations, see graphic below, I think it’s worth re-reading what Wolgen said years ago.
https://www.asx.com.au/asxpdf/20101110/pdf/...sm5bzb6dtjw.pdf

I think there are some other trials that never released full results, I haven’t completed an exhaustive review however I don’t recall ever seeing final results for CUV015 - Phase III Trial of CUV1647 in Polymorphic Light Eruption (PLE).

Clinical and regulatory progress:
- European and Australian Phase III trial (CUV015) preliminary results reported December 2009; see the announcement here
- Additional European Phase III trial (CUV032) commenced in Northern Hemisphere in spring of 2010
- Safety and efficacy shown in Phase II trials
- Program deferred

https://www.clinuvel.com/polymorphous-light-eruption-ple/

https://clinicaltrials.gov/ct2/show/NCT00472901
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investek
Posted on: Dec 9 2019, 12:26 AM


Group: Member
Posts: 259

Nice find sharelooker!

I agree that the patent application looks promising however I do not believe the progress had much/anything to do with FDA approval. From my limited understanding of patent law the 8th Oct date referenced is the date the EPO (European Patent Office) acknowledged receipt of the letter and it was initially drafted/sent by Farago on 27th Sept (before FDA approval was received).

I think the 8th Oct date on the patent site is just a coincidence.
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investek
Posted on: Dec 2 2019, 11:40 AM


Group: Member
Posts: 259

First Stop Loss level ($27) for the Citi warrants has been hit.

Will the other stop loss levels be breached before increased revenues push up the company fundamentals? (and hopefully the share price)
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investek
Posted on: Dec 2 2019, 10:21 AM


Group: Member
Posts: 259

PARVYSMELANOTIDE (VLRX001)
Parvysmelanotide (VLRX001) is an addition to the family of melanocortin analogues which provoke increased and prolonged cellular activity. It contains a specific peptide sequence, designed to make it less susceptible to degradation than physiologic (natural) alpha-melanocyte stimulating hormone (α-MSH).

The VLRX001 development work was undertaken through CLINUVEL’s Singaporean subsidiary, VALLAURIX and has leveraged the knowledge gained from long term experience with the clinical use of SCENESSE®. Formulation work will focus on the development of VLRX001 for topical self-administration by patients. The transdermal product will initially be evaluated as adjuvant maintenance therapy in the depigmentation disorder vitiligo. Overall, the development of VLRX001 is part of CLINUVEL’s life cycle management of its portfolio of products to ensure long term use and value of its technology and assets. CLINUVEL will hold all rights to the final product and indications through VALLAURIX.
https://www.clinuvel.com/pharmaceuticals/vlrx001
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investek
Posted on: Nov 30 2019, 04:43 PM


Group: Member
Posts: 259

QUOTE
I'm asking him about patents because I want to know where companies like Neova, ISDIN, and DNARenewal get their DNA repair enzymes. If the patents are expired, I ask, then these companies … are they producing their enzymes in-house?

"I know all those brands, I know their products" Yarosh says. "And all of their ingredients are coming from the same place: Esteé Lauder."


I think Wolgen is positioning the company to get acquired not once but twice!
Sell the rights to any cosmetic applications to the likes of Esteé Lauder.
Sell the rights to any medical applications to the likes of Galderma or AbbVie.

It appears that Estée Lauder acquired AGI for around $50mil?
https://sec.report/Document/0001104659-08-066226/

Estée Lauder has annual revenues of ~12bil USD and a market cap of ~70bil USD.
“Clinique is one of Estée Lauder‘s subsidiaries”

Clinique... Clinuvel... coincidence?
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investek
Posted on: Nov 30 2019, 04:23 PM


Group: Member
Posts: 259

I posted a link to this article over a year ago however it may be interesting reading for anyone that missed it.

DNA-Repairing Sunscreen: Legit or Not?
Several products claim to repair DNA damage inflicted by UVB rays. What's the science behind them?
https://www.wired.com/story/dna-repairing-s...n-legit-or-nah/

I also find it interesting that Dr Yarosh seemed to be heading down a similar path using treatment of XP to demonstrate DNA repair.

QUOTE
Effect of topically applied T4 endonuclease V in liposomes on skin cancer in xeroderma pigmentosum: a randomised study

Dr Daniel Yarosh, PhD Jonathan Klein, BS Adrienne O'Connor, MS John Hawk, MDElyse Rafal, MD Peter Wolf, MD et al. Show all authors
Published:March 24, 2001DOI:https://doi.org/10.1016/S0140-6736(00)04214-8

Summary Background

In patients with xeroderma pigmentosum the frequency of all forms of skin cancer is higher than in the general population, owing to a genetic defect in DNA repair. The bacterial DNA repair enzyme, T4 endonuclease V, delivered intracellularly, increases the rate of repair of sunlight-induced DNA damage in human cells. We tested the ability of this enzyme in a liposomal delivery vehicle applied topically (T4N5 liposome lotion) to lower the rate of new skin cancers in patients with xeroderma pigmentosum.
Methods

30 patients were enrolled in this prospective, multicentre, double-blind study. Patients were randomly assigned T4N5 liposome lotion or a placebo liposome lotion, to be applied daily for 1 year. At 3-monthly visits, new actinic keratoses and basal-cell carcinomas were identified and removed. Analyses were by intention to treat.
Findings

20 patients were assigned T4N5 liposome lotion and ten placebo lotion; one placebo-group patient withdrew before treatment and one withdrew with progressive disease at 9 months. The annualised rate of new actinic keratoses was 8·2 among the patients assigned T4N5 liposome lotion and 25·9 among those assigned placebo (difference 17·7 [95% CI 11·8–26·5]; p=0·004 by Poisson modelling). For basal-cell carcinoma, the annualised rates of new lesions were 3·8 in the treatment group and 5·4 in the placebo group (difference 1·6 [0·38–2·82]). No significant adverse effects were found among any of the patients.
Interpretation

DNA damage has an important role in the development of skin cancer and precancerous skin lesions. The topical application of DNA repair enzymes to sun-damaged skin of patients with xeroderma pigmentosum lowered the rate of development of two forms of these lesions during a year of treatment.


Perhaps he would make a good addition to the board?
http://www.danyarosh.com/about.html
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investek
Posted on: Nov 29 2019, 10:59 PM


Group: Member
Posts: 259

NHS England Publishes Draft Commercial Framework for Medicines

NHS England has recently published draft proposals on how it plans to approach doing commercial deals with pharmaceutical companies for branded medicines. This draft “Commercial Framework” is now open for comment and consultation (stakeholders can submit their views here). The consultation period ends on 10 January 2020, with Commercial Framework expected to be finalized later in 2020.

The Commercial Framework describes how NHS England, the National Institute for Health and Care Excellence (“NICE”) and pharmaceutical companies could work together to support the introduction of clinically and cost-effective branded medicines into the NHS, by striking commercial deals.

Developing and publishing the Commercial Framework makes good a commitment made in the 2019 Voluntary Scheme for Branded Medicines Pricing and Access (“Voluntary Scheme”). The Voluntary Scheme is one of two price control schemes operational in the UK, which restrict prices that the NHS pays for many branded medicines. The 2019 Voluntary Scheme refreshed and replaced the former Pharmaceutical Price Regulation Scheme (“PPRS”). One of the key themes of the new scheme was to add more flexibility to market-access, including in some cases by finding commercially negotiated ways forward.

The draft Commercial Framework makes clear its intention to support NICE’s health technology appraisal process (by which NICE issues a recommendation on a product’s use within the NHS), rather than act as an alternative or substitute to it. In that context, the draft sets out various commercial options available to companies through the market-access process. Some of these options are already well-established parts of the NICE’s assessment framework, including (for example):

Simple or Complex Patient Access Schemes – by which a reimbursement recommendation from NICE is contingent on a company offering a confidential percentage discount to the NHS or more complex, non-confidential value propositions; and
Managed Access Agreements – which are, in essence, commercial deals for a fixed period that allow time to resolve clinical or cost-related uncertainties at the time of a NICE appraisal.
Importantly, the draft Commercial Framework also proposes when and how NHS England might agree to so-called “Confidential Commercial Agreements.” NHS England might consider these agreements in the following circumstances:

When a company intends to put an “enhanced value” offer to the NHS. In essence, this allows a company to put together a complex and confidential commercial deal, with the emphasis on delivering cost-effectiveness under NICE’s standard assessment methods.
When “unusual or unique circumstances” surrounding a NICE appraisal make launch a particular product challenging or commercially unviable to the company developing it. In those circumstances, NHS England has the ability – on a case-by-case basis — to reach a bespoke solution with the company concerned. The draft proposal states that NHS England would have this level of commercial flexibility only when the product offers a significant health gain and when the company would otherwise lose significant revenue that it could not recover in later years. This could be an important development for high-cost; high-benefit products resulting from expensive, pioneering innovation.

Separately, the draft Commercial Framework sets out how NICE and NHS England aim to engage with pharmaceutical companies at an early stage to discuss market access and give preliminary direction to the process.

The draft document also makes clear that the Commercial Framework is designed to be a living document. Eventually, the aim is to broaden its scope to cover biosimilar and generic products, in addition to branded medicines.
https://www.lexology.com/library/detail.asp...70-8ae7b770240b


NHS Commercial Framework for Medicines
Closes 10 Jan 2020, Opened 1 Nov 2019
Contact - Ben Doak
Commercial Medicines Directorate
england.commercialmedicines@nhs.net
https://www.engage.england.nhs.uk/consultat...858b8-189917297

NHS Commercial Framework for Medicines
https://www.engage.england.nhs.uk/consultat...work-001218.pdf

NHS Commercial Framework for Medicines – Frequently Asked Questions (FAQs)
https://www.engage.england.nhs.uk/consultat...faqs-001218.pdf
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investek
Posted on: Nov 28 2019, 10:38 AM


Group: Member
Posts: 259

QUOTE
"It's very interesting to see a lot of famous and high quality luxury packaging exhibitors from Korea and we managed to acquire some prospective suppliers," said Clarabelle Ang, Laboratory Technician with Singapore's Vallaurix Pte Ltd.“


http://www.asiaone.com/business/global-bea...oprof-asia-2019

https://sg.linkedin.com/in/clarabelle-ang-30725721
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investek
Posted on: Nov 25 2019, 03:17 PM


Group: Member
Posts: 259

Shorts at an all time high!

Nearly 3.2mil shares sold short.

ShortMan has been gagged by the ASX yet again regarding publishing daily short activity!!! (I’d say ‘unbelievable’ however not much is surprising me these days).

I might place a few buy orders at the Citi Mini Long Warrant, stop loss trigger levels... not advice and do your own research.


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investek
Posted on: Nov 23 2019, 06:20 AM


Group: Member
Posts: 259

Thanks somersby.

An interesting link/connection however the relationship between immunotherapy and vitiligo seems quite complex...

Connecting the Dots: Vitiligo Can Predict Immunotherapy Response in Melanoma
https://www.curetoday.com/publications/cure...nse-in-melanoma
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investek
Posted on: Nov 18 2019, 02:38 AM


Group: Member
Posts: 259

Is anyone a current investor in the Tribeca Alpha Plus Fund or has access to information on the underlying investments?

“Information on underlying investments
Information regarding the underlying investments of the Fund will be provided to an investor of the Fund on request, to the extent Equity Trustees is satisfied that such information is required to enable the investor to comply with its statutory reporting obligations. This information will be supplied within a reasonable timeframe having regard to these obligations.”
https://www.eqt.com.au/~/media/equitytruste...class-b-pds.pdf

It doesn’t look like ASIC will be much help in seeing portfolio construction (I wonder if this will include short positions)

“19-295MR ASIC extends relief for portfolio holdings disclosure

ASIC has amended ASIC Class Order [CO 14/443] to provide legal certainty about the first reporting day for portfolio holdings disclosure, given the regulations setting out the required disclosures have not yet been made.

Most superannuation trustees, as part of portfolio holdings disclosure requirements, must provide information about fund holdings on the fund website. The first reporting date to identify the holdings of the fund was to be 31 December 2019, with disclosure required on the trustee’s website no later than 90 days from this date. However, the regulations which set out the way in which this disclosure is to be organised have not been made.

The amendments made to CO 14/443 defer the first reporting day to 31 December 2020. This will allow further time for Government to develop and make the regulations. It also provides industry with certainty about the commencement date and time to finalise their reporting processes and disclosures.

ASIC supports greater transparency about funds’ portfolio holdings and encourages superannuation trustees to focus on designing website disclosure about holdings that is accessible and clear for their members. ASIC notes that a number of funds have already taken steps to increase transparency about their portfolio holdings even in the absence of an explicit legislative obligation to do so.”
Emphasis mine.
https://asic.gov.au/about-asic/news-centre/...ngs-disclosure/
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investek
Posted on: Nov 18 2019, 01:07 AM


Group: Member
Posts: 259

Thanks Sharelooker.

Jun Bei Liu is the lead portfolio manager of the Tribeca Alpha Plus strategy.
https://tribecaip.com/team/jun-bei-liu/

So what are the odds that Jun is our shorter? (or one of them?)

I find it interesting, but not surprising, that there is no mention of the potential label extensions and additional indications that SCENESSE could be therapeutic for.

QUOTE
Has the market got ahead of itself paying 1.5 times the total addressable market for this business? We think so. Particularly as there are now competing drugs being developed and its patent on SCENESSE is expiring in two years, which means generics could come in and lower prices. We believe the company will absolutely be on the hunt for acquisitions to broaden its product portfolio, particularly while its share price is high. This is just one example of where valuations have exceeded any reasonable basis of value.

Emphasis above is mine.

Considering the Tribeca Alpha Plus strategy is a long/short fund and the published views above, I believe Jun/tribeca may be short CUV.
I wonder if she’ll be attending the AGM?
https://www.gsfm.com.au/our-funds/tribeca-alpha-plus-fund/

*Apologies, just realised there is no position disclosure associated with the article so Jun Bei/Tribeca couldn’t have an active position in CUV (could they?)
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investek
Posted on: Nov 7 2019, 11:05 AM


Group: Member
Posts: 259

Thank you ShortMan!
https://www.shortman.com.au/stock?q=CUV

I suspected this may be the case yesterday, shorters driving down the price yet again. Roughly 40% of yesterday’s volume was shorting ~100k shares.

It still fascinates me how the shorts will cover their positions without sending the share price thru the roof. We know the stock is thinly traded and many long termer’s don’t plan on selling many/any shares. How will they achieve this? Who will sell them circa 3mil shares and at what price?
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investek
Posted on: Nov 7 2019, 12:48 AM


Group: Member
Posts: 259

Nice initial post Matt! Thanks for sharing.

I raised the prospect a while back of us (lowly) retail shareholders banding together to call a General Meeting. Perhaps the latest performance rights proposal is enough to galvanise us into action.
We would require support from 5% of the register (which I believe we have) to be able to call such a meeting (unfortunately the old 100 shareholders rule has been changed, your PDF has already gathered more than 100 views).
https://hallandwilcox.com.au/thinking/the-r...rporations-act/

Unfortunately I think the company could stall such a meeting until after the AGM so we may be better placed writing to the board directly (as per your letter) and voting our shares (not leaving it to the management proxy).

____________

I also thought it was worth sharing that the European patent for a new Pharmaceutical Compound was granted to Vallaurix today, see below page 954 of the PDF.

https://patentscope.wipo.int/search/en/deta...ATCOLLDOCUMENTS

https://www.epo.org/app/bulletin/bulletin1945.pdf
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investek
Posted on: Oct 31 2019, 04:53 PM


Group: Member
Posts: 259

Tbh I’m still reeling from the last performance rights grant (2014), where Wolgen was ‘gifted’ circa 5% of the company. As least this time around there is a bit more discussion and debate on the forums, so hopefully more holders will make the effort to vote rather than leaving management to be their proxy.

Let me be clear, I’m all for well structured incentive plans and I believe it is very important for management and shareholder interests to be aligned. I honestly thought that the last performance rights were (more than) enough to ensure this was the case for as long as CUV continued to exist. (One exception may be the lower level management/staff which I believe should also be rewarded with some equity, however it is difficult to gauge how much, if any, of this has already taken place.)

It is starting to feel a bit hypocritical when we have the CEO saying in interviews that CUV is ‘leading the way’ in drug development spending only ~$130mil to get a NME to market (vs. the average $500mil +) yet his existing stake in the company (which was gifted to him) is already worth $100mil and would easily be worth north of $130mil once this current performance rights plan is passed.

With his current holding if Wolgen can get CUV’s market cap to $7.5b he stands to make circa $400mil (on top of today’s value). Does he really need the extra ~1.5mil shares to further incentivise him for a potential ~$200mil more?!

I can’t help thinking that the performance rights if distributed further down the food chain to other employees within CUV could have a bigger impact on company performance. Also what could be done with an equivalent amount of cash - circa $45mil? (that the dilution would equate to)
- CUV could staff all specialist EPP centres with nurses to assist with the rigorous PASS protocol and processing of patient backlog
- Multiple new indication trials could be kicked off and run in parallel
- Over 600 trams could be covered in CUV OTC topical advertising to generate additional company and product awareness (as wasteful as this may be I think I’d still feel better about it!)
https://www.trulydeeply.com.au/2013/05/tom-...personal-brand/

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investek
Posted on: Oct 28 2019, 10:56 PM


Group: Member
Posts: 259

I thought this was worth sharing and whilst I find it shocking that the primary Australian exchange is making moves towards less transparency I can’t say that I’m totally surprised!

To the person behind Shortman, thank you, I have found your site very informative and helpful over the years (as I’m sure have many on Sharecafe).

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investek
Posted on: Oct 18 2019, 08:29 PM


Group: Member
Posts: 259

Given CUV now has FDA approval and Stan’s retirement has been announced I thought this was worthy of a re:post (from Sept 23rd)

Which Australian based (biotech?) exec will fill the board seat left vacant by Stan??

QUOTE
Ok so the latest board appointment puts CUV in the rare category of having equal gender representation at board level (3 female, 3 male).

“The latest percentage of women on ASX 200 boards is 29.7% (31 July 2019)”
https://aicd.companydirectors.com.au/advoca...sity/statistics

Now the question is if CUV do manage to get FDA approval in the coming weeks (pun intended), then who will replace Stan McLiesh? The safe money is on Blijdorp getting the Chairman role however which Australian based exec would take the board seat vacated by Stan?

Minimum requirements for companies registered under the Corporations Act 2001:
Public company: 3 directors of which 2 must ordinarily reside in Australia;
https://aicd.companydirectors.com.au/~/medi...ors_a4-web.ashx

Ideas anyone??
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investek
Posted on: Oct 13 2019, 11:00 PM


Group: Member
Posts: 259

I find this quite exciting! A major step forward in the OTC/new formulations IMHO.
Personally I think Wolgen has been waiting for this grant to take place before disclosing more info (hence the stalled progress).
Note: on the telecon, he specifically mentioned the IP and need to protect future formulations.

https://patentscope.wipo.int/search/docs2/w...European_patent

Vallaurix has been granted European patent #3288967, well technically the grant will be in effect from the date of publication on 6th Nov 2019!

PHARMACEUTICAL COMPOUND
Abstract: The present invention relates to an alpha-MSH analogue compound, the use in skin diseases, and the preparation.
https://patentscope.wipo.int/search/en/deta...ATCOLLDOCUMENTS

Text intended for grant
https://patentscope.wipo.int/search/docs2/w...nt_(clean_copy)
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investek
Posted on: Oct 11 2019, 01:17 AM


Group: Member
Posts: 259

Evolution of the Thorough QT/QTc study
https://www.celerion.com/wp-content/uploads...T-QTc_study.pdf
QUOTE
Some drugs with multiple potential indications are submitted to different divisions within the FDA. There was initially little uniformity between divisions in their approach as to whether a TQT was needed or how it would be designed. The FDA assembled an Interdisciplinary Review Team (IRT) with members from project management, medical, statistics, and pharmacology from across several divisions in 2006.20 The IRT has been successful in providing more uniformity in QT evaluation across these divisions. The IRT should review all TQT study designs to make sure they are complying with E14, especially if the study is not the “classic” design outlined above. In order to evaluate the study design, the IRT requests a significant amount of data about the compound. They developed a document, the Clinical Highlights of Pharmacology,21 to collect all that information in one place. Inadequate characterisation of a compound’s pharmacology has resulted in delayed IRT reviews in the past. The IRT is advisory to the review divisions and those divisions still make the ultimate decision about TQT assessment, though they do tend to follow the IRT recommendations closely.
The IRT has reviewed more than 170 TQT study reports. As mentioned above, it has intermittently shared information gathered from those exercises at meetings and in the literature. For example, the FDA recently revealed that eight TQT studies had an inadequate moxifloxacin response, making the studies uninterpretable. Seven of these studies were parallel design. The FDA has advocated that parallel studies have a combined placebo/moxifloxacin arm (nested) rather than two separate arms. This allows a closer temporal assessment of moxifloxacin and study drug QT effects, which may decrease the moxifloxacin failures in parallel studies. 22


One possibility I can think of is that Wolgen has shared more details than we realise with the FDA, potentially several future indications, other skin conditions eg psoriasis, neuro eg MS, gut? occular? Cardiac? (Deficiency in Melanocortin 1 Receptor Signaling Predisposes to Vascular Endothelial Dysfunction and Increased Arterial Stiffness in Mice and Humans), perhaps one of these other potential applications or something flagged by the IRT prompted the need for the review?

https://www.ahajournals.org/doi/10.1161/ATVBAHA.114.305064

And this too...could be pretty standard for ‘new’ drugs...
QUOTE
The QT interval occupies a pivotal role in drug development as a surface biomarker of ventricular repolarization. The electrophysiologic substrate for QT prolongation coupled with reports of non-cardiac drugs producing lethal arrhythmias captured worldwide attention from government regulators eventuating in a series of guidance documents that require virtually all new chemical compounds to undergo rigorous preclinical and clinical testing to profile their QT liability.

QT Assessment in Early Drug Development: The Long and the Short of It
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6471571/
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investek
Posted on: Oct 11 2019, 12:39 AM


Group: Member
Posts: 259

Not way ahead of you, just a couple of clicks, unfortunately I can’t speak to this with any knowledge/authority (need to keep digging).
Maybe something to do with the fact it is systemic/long term/slow release drug?

I echo scipio79, the language ‘administrative only’ sounds positive!
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investek
Posted on: Oct 11 2019, 12:17 AM


Group: Member
Posts: 259

Guidance for Industry
E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
https://www.fda.gov/media/71372/download
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investek
Posted on: Oct 10 2019, 03:00 PM


Group: Member
Posts: 259

Looks like Moelis have upped their valuation to $50.91 (unfortunately I can’t locate the pdf yet)

http://research.moelis.com.au/ResearchPortal/LatestResearch#
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investek
Posted on: Oct 9 2019, 01:37 AM


Group: Member
Posts: 259

Some rare disease news on the FDA announcement page...

FDA awards two grants for natural history studies in rare diseases

October 08, 2019
FDA News Release

For Immediate Release:
The U.S. Food and Drug Administration today announced it has awarded two new research grants for natural history studies in rare diseases. The FDA is providing over $4.1 million over the next four years to fund these studies. Information from natural history studies can facilitate design of efficient clinical trials to test future treatments.

Natural history studies closely look at how specific diseases progress over time. The natural history of a disease is the course a disease takes from its onset, through the presymptomatic and clinical stages, to a final outcome in the absence of treatment.

“The FDA is committed to funding these important studies in order to define how rare diseases develop and progress,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “Further, these studies provide important roadmaps for how to conduct subsequent studies. With the natural history of many rare diseases remaining relatively unknown, efficiently developing diagnostics and therapies for patients poses unique challenges. Promoting and conducting work in this area is critical.”

The FDA received 31 grant applications that were reviewed and evaluated for scientific and technical merit by more than 45 rare disease, natural history, regulatory and statistical experts, that included representatives from academia, patient groups, the National Institutes of Health and the FDA. The grants were awarded to:

University of Texas MD Anderson Cancer Center (Houston, Texas), Elizabeth Grubbs, prospective study in medullary thyroid carcinoma, approximately $1.7 million over four years

The study seeks to leverage a multi-institutional registry to characterize disease variables and patient perspectives that inform decisions regarding initiation of and adherence to chemotherapy in medullary thyroid cancer. Such critical knowledge can be incorporated into the design of clinical trials of emerging therapies for this disease.

Vanderbilt University Medical Center (Nashville, Tennessee), Jonathan Soslow, prospective study in cardiac disease in Duchenne muscular dystrophy, approximately $2.4 million over four years.

This study aims to focus on cardiomyopathy (heart muscle disease), which is the leading cause of death in Duchenne muscular dystrophy. The study will combine genetic differences with imaging and blood biomarkers to identify surrogate biomarkers that predict the risk of cardiac dysfunction in Duchenne muscular dystrophy and other related diseases. This information has the potential to improve future clinical trial efficiency in these diseases by decreasing their size and cost.
Congress appropriates funding to the FDA for the study of rare diseases. The FDA uses these funds for the Orphan Products Grants Program to support these natural history studies as well as clinical trials for rare diseases.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
https://www.fda.gov/news-events/press-annou...s-rare-diseases

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

October 08, 2019
FDA News Release

For Immediate Release:
The U.S. Food and Drug Administration today announced that it has awarded 12 new clinical trial research grants totaling more than $15 million over the next four years to enhance the development of medical products for patients with rare diseases. The grants were awarded to principal investigators from academia and industry across the country.

The FDA awarded the grants through the Orphan Products Clinical Trials Grants Program, funded by Congress to encourage clinical development of drugs, biologics, medical devices and medical foods for the treatment of rare diseases. The grants are intended to substantially contribute to marketing approval of products to treat rare diseases or provide essential data needed for development of such products.

“For more than 35 years, the FDA has been providing much-needed financial support for clinical trials of potentially life-changing treatments for patients with rare diseases. To date, the Orphan Products Clinical Trials Grants Program’s grants have supported research that led to the marketing approval of more than 60 treatments for rare diseases,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “We are encouraged by the amount of interest we continue to have in the grants program and are committed to working with researchers and industry to facilitate and support the study and development of treatments for patients with rare diseases.”

The FDA received 89 clinical trial grant applications that were reviewed and evaluated for scientific and technical merit by more than 100 rare disease experts, including members of academia.

The grants awarded are focused on supporting product development to meet the needs of patients impacted by a variety of rare diseases, mainly those affecting children and cancers. The recipients, principal investigators and approximate funding amounts, listed alphabetically, are:

Chemocentryx, Inc. (Mountain View, California), Peter Staehr, phase 2 study of avacopan for the treatment of complement 3 glomerulopathy – $1 million over two years
Cincinnati Children’s Hospital Medical Center (Cincinnati, Ohio), Maryam Fouladi, phase 1 study of PTC596 for the treatment of diffuse intrinsic pontine glioma & high-grade gliomas -- $750,000 over three years
Cincinnati Children’s Hospital Medical Center (Cincinnati, Ohio), Parinda Mehta, phase 2 study of quercetin chemoprevention for the treatment of squamous cell carcinoma in patients with Fanconi Anemia – $1.7 million over four years
Columbia University Health Sciences (New York, New York), Gary Brittenham, phase 2 study of daily vitamin D for the treatment of sickle-cell respiratory complications – $2 million over four years
Cumberland Pharmaceuticals, Inc. (Nashville, Tennessee), Ines Macias-Perez, phase 2 study for oral ifetroban for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy – $1 million over three years
Massachusetts General Hospital (Boston, Massachusetts), Sara Pai, phase 2 study of anti-PD1 therapy for the treatment of HPV-associated recurrent respiratory papillomatosis – $1 million over three years
New York Medical College (Valhalla, New York), Mitchell Cairo, phase 2 study of viral specific cytotoxic T-lymphocytes for the treatment of refractory viral infections and T-cell immunodeficiency – $1.7 million over four years
Privo Technologies, LLC. (Peabody, Massachusetts), Manijeh Goldberg, phase 1/2 study of cisplatin patch (PRV111) for the treatment of oral cancer – $2 million over four years
Targeted Therapy Technologies, LLC (Somerset, New Jersey), Ricardo Carvalho, phase 1 study of episcleral topotecan for the treatment of retinoblastoma – $660,000 over three years
University of Alabama at Birmingham (Birmingham, Alabama), Gregory Friedman, phase 1 study of oncolytic engineered herpes simplex virus therapy for the treatment of pediatric malignant cerebellar brain tumors – $750,000 over three years
University of California San Diego (La Jolla, California), Jason Sicklick, phase 2 study of temozolomide for the treatment of gastrointestinal stromal tumor – $1.5 million over three years
University of Texas MD Anderson Cancer Center (Houston, Texas), Michael Andreeff, phase 1/2 study of the imipridone (ONC201) for treatment of acute myeloid leukemia – $1 million over four years
“The majority of rare diseases still do not have approved therapies and the FDA is committed to fostering product development in areas of unmet need. The Orphan Products Grants Program is one of several ways that the FDA supports the development of products for rare diseases. Since its creation in 1983, the program has provided more than $400 million to fund more than 600 new clinical studies,” said Janet Maynard, M.D., director of the FDA’s Office of Orphan Products Development. “We are pleased to continue to support research for a variety of rare diseases that have little, or no, treatment options for patients. By helping to spark research, we hope to speed the development of products for rare diseases, and ultimately, make needed treatments available to those patients who need them most.”

Three-quarters (75%) of the new awards fund studies enrolling children, including children as young as one month. These studies target a variety of rare diseases affecting children and have the potential to advance treatments for these diseases. Some of these diseases include Duchenne Muscular Dystrophy, a genetic disorder characterized by progressive muscle loss and weakness; sickle cell disease, a group of inherited red blood disorders which can cause anemia, infections and stroke; and Fanconi Anemia, a rare inherited condition that can result in bone marrow failure and has a high risk for squamous cell cancers.

Two-thirds (67%) of the new awards fund clinical studies of products for use in various rare cancers. For example, one of the new awards aims to advance research in brain cancers affecting children. This study enrolls affected children as young as 36 months and tests an innovative treatment approach to treat brain cancers using an engineered virus therapy designed to target and kill tumor cells while sparing normal brain cells. Another newly funded study evaluates a novel drug delivery system that delivers chemotherapy on a sustained basis directly to the eye to treat retinoblastoma, a rare cancer in the eye most commonly affecting young children. This delivery system may help address current barriers to drug delivery that patients face.

Past studies funded by this program that have resulted in or contributed to recent product approvals, include: fish oil triglycerides, a first FDA-approved lipid emulsion made from fish oil, approved as a source of calories and fatty acids in children with parenteral nutrition-associated cholestasis; and the first treatment (tafamidis meglumine and tafamidis) for heart disease caused by transthyretin mediated amyloidosis.

In addition to the FDA Orphan Products Clinical Trials Grants Program, the agency also supports natural history studies for rare diseases to further advance the FDA’s mission of bringing new therapies to approval and patients.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
https://www.fda.gov/news-events/press-annou...reatment-rare-0
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investek
Posted on: Oct 7 2019, 05:07 PM


Group: Member
Posts: 259

.
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investek
Posted on: Oct 4 2019, 05:55 PM


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NICE Methods Review
A report of the All-Party Parliamentary Group on Access to Medicines and Medical Devices
https://www.treatsma.uk/wp-content/uploads/...cal-Devices.pdf
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investek
Posted on: Oct 4 2019, 04:59 PM


Group: Member
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UK Politicians Want NICE To Use Conditional Reimbursement 18 Sep
Francesca.bruce@informa.com
Executive Summary

A UK parliamentary report has called for the HTA body NICE to consider the use of conditional reimbursement recommendations and more flexible cost-effectiveness thresholds in its ongoing methods review.
https://pink.pharmaintelligence.informa.com...l-Reimbursement
  Forum: By Share Code

investek
Posted on: Oct 1 2019, 10:29 PM


Group: Member
Posts: 259

Thanks sharelooker! (Gotta love the timing of the release)

A couple of more links on the same (and one from back in 2014)

QUOTE
“The EMA states that afamelanotide will be the first medication evaluated with patient input. The agent for the treatment of erythropoietic protoporphyria (EPP) is currently under evaluation by the CHMP. EPP is a rare genetic blood disorder, which causes sufferers to experience a complete intolerance to light. At a September 2014 CHMP meeting, two EPP patients discussed the condition and afamelanotide with committee members, and their input is to be incorporated into CHMP’s assessment.”

https://www.clinicalleader.com/doc/ema-seek...ew-process-0001

Engaging patients in medicines regulation: a tale of two agencies
https://www.nature.com/articles/d41573-019-00164-y

Patient-Focused Drug Development: Methods to Identify What Is Important to Patients
https://www.fda.gov/media/131230/download
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investek
Posted on: Oct 1 2019, 08:39 PM


Group: Member
Posts: 259

I found this interesting,
QUOTE
The number of traded orders (Buys and Sells) by CommSec customers for all trading days during the past 30 calendar days.


So even though the buy orders out number the sell orders by roughly 2:1 (and I understand this is number of orders not order size) the share price has still dropped by ~10% over the period.
Hmm...
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investek
Posted on: Sep 30 2019, 01:33 PM


Group: Member
Posts: 259

Well it seems my hypothesis was incorrect. 25th Sep resulted in <15% of shares traded being sold short, and the share price still fell.

That said the gross shorts were ~30k, significantly higher than the 20k and 13k on the green days of Tue and Thurs.

The shorter seems determined to drive down the price and appears to have many millions of dollars to do so. I can’t recall who made the comment, xray?, however I think I agree “The shorter is really a buyer!”

Also, I agree that FDA approval would legitamise the company/drug. It would not surprise me if we began to see sustained buying/accumulation post an FDA approval (similar to when Fidelity was accumulating years ago), it would also not surprise me to see muted share price action until additional revenues and profit drive fundamentals again.

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investek
Posted on: Sep 25 2019, 02:48 PM


Group: Member
Posts: 259

So yesterday we saw a decent share price rise (circa 4%) and it seemed to align with a low volume of shorting (<10% of shares traded, and yes I understand that this is the gross figure for the day and not the net/aggregate figure that we will need to wait a few more days for).

My hypothesis is that today will result in >15% of shares traded being sold short.

We will see what shortman has to say tomorrow...
https://www.shortman.com.au/stock?q=CUV


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investek
Posted on: Sep 23 2019, 11:32 PM


Group: Member
Posts: 259

Ok so the latest board appointment puts CUV in the rare category of having equal gender representation at board level (3 female, 3 male).

“The latest percentage of women on ASX 200 boards is 29.7% (31 July 2019)”
https://aicd.companydirectors.com.au/advoca...sity/statistics

Now the question is if CUV do manage to get FDA approval in the coming weeks (pun intended), then who will replace Stan McLiesh? The safe money is on Blijdorp getting the Chairman role however which Australian based exec would take the board seat vacated by Stan?

Minimum requirements for companies registered under the Corporations Act 2001:
Public company: 3 directors of which 2 must ordinarily reside in Australia;
https://aicd.companydirectors.com.au/~/medi...ors_a4-web.ashx

Ideas anyone??
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investek
Posted on: Sep 21 2019, 12:00 AM


Group: Member
Posts: 259

Gee the shorter has been working hard to keep a lid on the share price.

In order to stop the price running away on them on Thursday morning (19th Sept) it appears they sold ~175k shares in the first hour. To me this is a very bullish sign.

Sure the shorter has been able to drive down the share price (with additional artificial selling) however at some stage they will have to repurchase nearly 3 million shares.
I can see 3 possible scenarios:
1) If CUV receives a CRL the shorter could potentially close their positions at a decent profit
2) Related party transactions allow the shorter to close their positions at a slight profit/break even (pretty sure this is illegal as it would imply share price manipulation wouldn’t it?)
3) CUV share price driven to all new highs via a short squeeze


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investek
Posted on: Sep 17 2019, 12:35 AM


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Posts: 259

BioMarin and NICE had a rocky start with Batten disease therapy Brineura, but the two have now come to an agreement
The positive recommendation of Brineura was agreed by NICE’s Highly Specialised Technology committee. The disease, known as neuronal ceroid lipfuscinosis type 2 (CLN2), is a very rare inherited condition. According to NICE, it is thought to affect between one and six babies every year in the UK.
Although Brineura does not does not cure the disease, NICE agreed that it is an important development in the treatment of the condition. There is currently no cure or life-extending treatments for CLN2, so the approval is likely to be met with elation from patient groups.
Boysen
Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE
“This treatment shows great promise in slowing the progression of this devastating condition to allow children to enjoy normal childhood activities for longer which is so important,” said Meindert Boysen (pictured above).
The initial decision to reject the therapy was down to the cost of the therapy. Despite the disease affecting up to six infants each year (with up to 50 children in the UK living with the condition), the £500,000 ($651,100) per patient per year price tag was considered to not be value for money in the absence of long-term effectiveness data.
However, the therapy has now been approved in the context of a managed access agreement between BioMarin and the cost-effectiveness watchdog. BioMarin have said that the two have “agreed a fair price”, but as the financial details of the deal are confidential, the exact amount is unknown. However, it is likely that BioMarin will have had to make a concession on price to reach an agreement.
The announcement coincides with an ongoing judicial review, which would have looked at new evidence supporting the therapy. NICE seems to have jumped the gun, approving the therapy before the review of the new data.
Health Secretary Matt Hancock also commented on the approval: “I’m absolutely delighted this new treatment will be funded by the NHS, giving families dealing with the devastating impact of Batten disease renewed hope for a better quality of life for their child.”
NICE is due to provide a further update on the expected publication date of the Final Evaluation Document soon, which will reveal the full details of the committee discussion and recommendation.
Article by
Lucy Parsons
12th September 2019
https://www.pmlive.com/pharma_news/nice_app...IGN_NAME=2&

And an earlier article
Brineura hit with NICE rejection
http://www.pharmatimes.com/news/brineura_h...jection_1279019

Brineura
https://www.nice.org.uk/guidance/indevelopment/gid-hst10008
NICE appeal - 1st May 2019
And a total of 5 committee meetings...

Afamelanotide
https://www.nice.org.uk/guidance/indevelopment/gid-hst10009
NICE appeal - 20th June 2018
3 committee meetings so far...
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investek
Posted on: Sep 16 2019, 10:31 PM


Group: Member
Posts: 259

Total amounts reimbursed (* € 1,000), number of insured persons and average reimbursement per insured person (* € 1,000) per product per year

https://www.zorginstituutnederland.nl/binar...aktijk+2019.pdf

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investek
Posted on: Sep 16 2019, 04:30 PM


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AD treatment advances on psoriasis research
ILYA PETROU, M.D. | Staff Correspondent
Continued research and development in psoriasis has led to a translational revolution — the lessons from which can now be observed in other common inflammatory diseases, such as atopic dermatitis, alopecia areata, vitiligo, hidradenitis suppurativa, acne, and rosacea. According to one expert, the journey has been arduous but, due to the years-long work on psoriasis, the future is bright for patients with inflammatory skin diseases.
Atopic dermatitis and psoriasis are characterized by immune-mediated inflammation and abnormal keratinocyte differentiation and, although their T-cell infiltration characterizes both diseases, T-cell polarization differs. Because of their similarities however, the therapeutics for atopic dermatitis, in particular, have benefit- ted from continued psoriasis research.
“It took decades for us to get from relatively primitive treatments of psoriasis to the very advanced perfected treatments that we currently have available, and we can clear almost everybody with these therapies. The advent of the biologics around the turn of the century has changed the treatment and management of inflammatory skin diseases forever,” says Mark Lebwohl M.D., FAAD, Sol and Clara Kest professor and chairman of the department of dermatology at Mount Sinai School of Medicine, New York, New York.
Cyclosporine worked well but it basically knocked out the whole immune system, Dr. Lebwohl says, making patients more susceptible to cancers, opportunistic infec- tions, as well as a host of other side effects. Current advanced treat- ment approaches include therapies that target individual molecules in the immune system and lead to the clearing of inflammatory skin diseases that are immunologically mediated, without disrupting the immune system as a whole.
“The first biologics, like alefacept, were only modestly effective, and they targeted the activation of lymphocytes. These agents were designed to target just a tiny frac- tion of the immune system, which ultimately allowed us to treat psoriasis much more effectively, Dr. Lebwohl says.
The TNF (tumor necrosis factor) blockers also proved to be effective and although TNF is a much smaller target in the immune system compared to what cyclosporine targets, these agents still block a fair amount of the immune system, leading to an increase in opportunistic infections and a slight increase in skin cancers.
It was the realization of the critical importance of the IL-17 and IL-23 pathways that led to the development of numerous therapies that target and block only a very small part of the immune system, Dr. Lebwhohl says. And this has resulted in extraordinary clinical outcomes with very few side effects.
“IL-12 has once been likened to the master switch of psoriasis. Today, we know that blocking IL-12 also blocks IL-23. They share p40, a common molecule, and the antibodies to IL-12 are the same ones to IL-23,” Dr. Leb- wohl says.
As the only biologic currently approved by the U.S. Food and Drug Administration for atopic dermati- tis, dupilumab (Dupixent, Sanofi Regeneron Pharmaceuticals) is the first and only IL-4 and IL -13 anti- body used for patients with atopic dermatitis. Early results show that it can achieve dramatic clinical out- comes at the lowest dose. Follow- ing the success with dupilumab, a host of other biologic agents includ- ing tralokinumab (Leo Pharma) and lebrikizumab (Dermira) were devel- oped to target IL-13, and are achiev- ing positive clinical outcomes in tri- als with minimal side effects.
It was the realization of the critical importance of the IL-17 and IL-23 pathways that led to the development of numerous therapies that target and block only a very small part of the immune system, Dr. Lebwhohl says. And this has resulted in extraordinary clinical outcomes with very few side effects.
The role of IL-31 has also been well established in patients with pru- ritus and atopic dermatitis. Levels of
IL-31 are elevated in atopic dermatitis and corre- late with disease severity.
Other promising systemic agents for the treat- ment of atopic dermatitis are those that target this pathway, according to Dr. Lebwohl, including nemolizumab (Galderma), several JAK inhibi- tors: baricitinib (Olumiant, Eli Lilly), upadacitinib (ABT-494, AbbVie Inc.), Pfizer’s PF04965842, and the JAK-SYK inhibitor ASN002 from Asana.
Developed by Kiniksa Pharmaceuticals Corp., KPL-716 is a fully-human monoclonal antibody that, in addition to blocking oncostatin M (OSM), also inhibits IL-31, which, according to Dr. Leb- wohl, has also achieved remarkable results in pre- liminary clinical trials, particularly in the reduc- tion of pruritus.
The topical JAK inhibitor crisaborole (Eucrisa, Pfizer) is the first phosphodiesterase 4 (PDE4) inhibitor on the market that has demonstrated effi- cacy in controlling inflammation in atopic skin, according to Dr. Lebwohl.
“After almost a century of relatively primitive treatment options including systemic steroids, cyclosporine and a number of other immunosup- pressant drugs all associated with sometimes sig- nificant side effects, we now have a whole host of innovative therapies that, due to their smaller tar- get, can improve the symptoms of atopic dermati- tis with minimal side effects,” Dr. Lebwohl says. “The future is very bright for atopic dermatitis patients, as these new and exciting agents have been shown to help clear patients, particularly when recalcitrant to other tried therapies.”

https://www.dermatologytimes.com/sites/defa...t0919_ezine.pdf

Dr Lebwohl has previously received grants/research funding from CUV.




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investek
Posted on: Sep 13 2019, 03:31 PM


Group: Member
Posts: 259

Today’s trades look awful ‘bot like’.

Over 4,000 trades so far for 146k shares, av of ~36 shares per transaction.

More than half the trades (~2,300) have been for 20 shares or less.

Seems the shorter has done this before... they’ve managed to drive the price down (but we know this is an illiquid stock so no major achievement there), I’m sure such a fall has loosened shares from a few holders however I’m still not sure how they will close out (buy back) over 2.7mil shares.

Shortman shows decent shorting is still happening on the recent down days.

Iggy is more active than ever on the Yahoo board.

Everything is telling me to buy up as many shares as I can with any spare change.
(Not advice and do your own research)

I’m interested in other’s views...

GLTAH!
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investek
Posted on: Sep 12 2019, 01:44 AM


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From the German forum, credit to sirlutz.

https://translate.googleusercontent.com/tra...lXWo8VrbrAe-FGQ

Treatment at >70 years of age, in Germany!
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investek
Posted on: Sep 2 2019, 12:39 AM


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Yes. It’s a better angle of the earlier photo Johnny H posted...
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investek
Posted on: Sep 1 2019, 12:51 PM


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Posts: 259

A better photo of those plants...

I can see almonds, olives, avocado, coconut, I’m struggling to make out a few of the other items, jojoba? soybean?

From the Clinuvel website:
QUOTE
Moisturisers contain combinations of occlusives, emollients and humectants. Occlusives tend to be thick and greasy in texture and are better suited to dry skins or for use in some body moisturisers. According to Dr. J Kraft and dermatologist C. W. Lynde from The University of Toronto, occlusives reduce TEWL and have the most pronounced effect when applied to slightly dampened skin. Mineral oil is often used because of its favorable texture, but it is not as effective at preventing evaporation of water as many other occlusives. Some commonly used occlusives are: caprylic/capric triglycerides, mineral oil, lanolin, avocado or olive oil, petroleum, petrolatum, silicone, dimethicone, beeswax and cyclomethicone. Their main limitations include odor, potential to cause allergies and the greasy feel.

Emollients lubricate and soften the skin. They improve its appearance by filling in the spaces between rough, dead cells to achieve soft, smooth skin and provide a layer of oil on the skins surface to prevent water loss. They add that smooth, slippery feel to the moisturiser as they mainly consist of lipids (fats) and oils. Common emollients are: shea butter, petrolatum, lanolin, cyclomethicone, dimethicone copolyol, glyceryl stearates and propylene glycol linoleate, silicone, mineral oil, jojoba oil, avocado oil, soybean oil and vitamin E.


https://www.clinuvel.com/photocare/moisturisers
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investek
Posted on: Aug 28 2019, 04:29 PM


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I have a few observations from a cursory overview of the annual report.

1) First mention of ‘suncare’ for quite some time? (“development of proprietary suncare products”)

2) Confirmation that OTC products are in addition to CUV9900 and VLRX001, however still clinical in nature. “Are being developed and manufactured for clinical use” suggests this is happening now?

3) Performance milestones have changed
i. Listing on a new exchange has been removed (NASDAQ not on the cards?)
ii. Derivative of SCENESSE mentioned (Is this the first time this wording has been used? From memory Wolgen recently stated they will self distribute SCENESSE in the US, so distribution partnership for skincare products??)
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investek
Posted on: Aug 14 2019, 03:51 PM


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@polyphemus - Is it possible to see which broker(s) have been selling down while the short interest has been increasing of late?

Thanks in advance.
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investek
Posted on: Aug 9 2019, 05:54 PM


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If You Like EPS Growth Then Check Out Clinuvel Pharmaceuticals (ASX:CUV) Before It’s Too Late – Simply Wall St News
28 mins ago
Simply Wall St News

For beginners, it can seem like a good idea (and an exciting prospect) to buy a company that tells a good story to investors, even if it completely lacks a track record of revenue and profit. But as Peter Lynch said in One Up On Wall Street, ‘Long shots almost never pay off.’

So if you’re like me, you might be more interested in profitable, growing companies, like Clinuvel Pharmaceuticals (ASX:CUV). Now, I’m not saying that the stock is necessarily undervalued today; but I can’t shake an appreciation for the profitability of the business itself. While a well funded company may sustain losses for years, unless its owners have an endless appetite for subsidizing the customer, it will need to generate a profit eventually, or else breathe its last breath.

Check out our latest analysis for Clinuvel Pharmaceuticals

In the last three years Clinuvel Pharmaceuticals’s earnings per share took off like a rocket; fast, and from a low base. So the actual rate of growth doesn’t tell us much. As a result, I’ll zoom in on growth over the last year, instead. Like the last firework on New Year’s Eve accelerating into the sky, Clinuvel Pharmaceuticals’s EPS shot from AU$0.13 to AU$0.33, over the last year. You don’t see 161% year-on-year growth like that, very often.

I like to take a look at earnings before interest and (EBIT) tax margins, as well as revenue growth, to get another take on the quality of the company’s growth. Not all of Clinuvel Pharmaceuticals’s revenue this year is revenue from operations, so keep in mind the revenue and margin numbers I’ve used might not be the best representation of the underlying business. Clinuvel Pharmaceuticals shareholders can take confidence from the fact that EBIT margins are up from 32% to 52%, and revenue is growing. That’s great to see, on both counts.

ASX:CUV Income Statement, August 9th 2019
While it’s always good to see growing profits, you should always remember that a weak balance sheet could come back to bite. So check Clinuvel Pharmaceuticals’s balance sheet strength, before getting too excited.

It makes me feel more secure owning shares in a company if insiders also own shares, thusly more closely aligning our interests. So it is good to see that Clinuvel Pharmaceuticals insiders have a significant amount of capital invested in the stock. Notably, they have an enormous stake in the company, worth AU$205m. Coming in at 15% of the business, that holding gives insiders a lot of influence, and plenty of reason to generate value for shareholders. Very encouraging.

Clinuvel Pharmaceuticals’s earnings have taken off like any random crypto-currency did, back in 2017. That EPS growth certainly has my attention, and the large insider ownership only serves to further stoke my interest. The hope is, of course, that the strong growth marks a fundamental improvement in the business economics. So to my mind Clinuvel Pharmaceuticals is worth putting on your watchlist; after all, shareholders do well when the market underestimates fast growing companies. One of Buffett’s considerations when discussing businesses is if they are capital light or capital intensive. Generally, a company with a high return on equity is capital light, and can thus fund growth more easily. So you might want to check this graph comparing Clinuvel Pharmaceuticals’s ROE with industry peers (and the market at large).

https://simplywall.st/stocks/au/pharmaceuti...its-too-late-2/
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investek
Posted on: Aug 8 2019, 01:40 AM


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Posts: 259

New Purchase: Clinuvel Pharmaceuticals Ltd (CLVLY)
Fishman Jay A Ltd initiated holding in Clinuvel Pharmaceuticals Ltd. The purchase prices were between $15.55 and $26.5, with an estimated average price of $20.41. The stock is now traded at around $18.95. The impact to a portfolio due to this purchase was 0.04%. The holding were 9,000 shares as of .
https://www.gurufocus.com/news/923022/fishm...rp-chevron-corp

Jay A. Fishman, Ltd. provides investment counseling and portfolio management services to individuals, families, employee benefit plans, IRA’s and tax exempt institutions. The firm’s primary activities include investment management, portfolio reviews and personal financial consulting. Portfolios are individually managed with a disciplined investment philosophy and pursuant to each client's investment objective.
https://www.jaf-ltd.com
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investek
Posted on: Jul 30 2019, 08:21 AM


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Column 10: Could Silicon Valley ever be replicated?
https://www.clinuvel.com/social-media/subq/...r-be-replicated

By Giles Delaney* (Our favourite journalist that doesn’t really exist)
*This is the tenth column in a regular series about the big issues that affect CLINUVEL and the broader biopharmaceutical sector.
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investek
Posted on: Jul 27 2019, 04:26 PM


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Posts: 259

QUOTE
Whilst it’s pretty obvious what they are trying to do with Tsumoyle,
I haven’t been able to figure out what the meaning of the name, Chivere, is.
Does anyone have an idea about what that could refer to?


I haven’t had a chance to investigate this fully however this is what I have come up with so far...

CHIVÉRE could be a combination of CHI and VÉRE.

VÉRE could refer to ‘vere’ in Latin?
vere is an Latin word started with v. Here is the definition of vere in English
vere in fact, real, true.
vere vere
• adverb really, truly, actually, indeed; rightly, correctly, exactly; truthfully;
vere adverb
• really, truly, actually, indeed; rightly, correctly, exactly; truthfully

1) CHI could refer to qi or ch’i
In traditional Chinese culture, qi or ch'i (Chinese: 气; pinyin: qì About this soundqì) is believed to be a vital force forming part of any living entity. Qi translates as "air" and figuratively as "material energy", "life force", or "energy flow". Qi is the central underlying principle in Chinese traditional medicine and in Chinese martial arts. The practice of cultivating and balancing qi is called qigong.
https://en.m.wikipedia.org/wiki/Qi

2) CHI could refer to Crossover Hotspot Instigator (Chi sites are sometimes referred to as "recombination hot spots")
A Chi site or Chi sequence is a short stretch of DNA in the genome of a bacterium near which homologous recombination is more likely to occur than on average across the genome. Chi sites serve as stimulators of DNA double-strand break repair in bacteria,
https://en.m.wikipedia.org/wiki/Chi_site

“Chi-Dependent High-Molecular-Weight DNA of Plasmids
The formation of high-molecular-weight (HMW) DNA by certain Chi-containing plasmids in E. coli has led some to argue that Chi blocks DNA degradation in cells.”
How RecBCD Enzyme and Chi Promote DNA Break Repair and Recombination: a Molecular Biologist's View
https://mmbr.asm.org/content/76/2/217

So CHIVÉRE could refer to:
1) True life force, or
2) Actually blocks DNA degradation —> Anti-aging
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investek
Posted on: Jul 26 2019, 05:17 PM


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Sumoylation Pathway as Potential Therapeutic Targets in Cancer.
Gong L, et al. Curr Mol Med. 2017.

Abstract
Sumoylation is a covalent protein posttranslational modification that conjugates the small ubiquitin-like peptide SUMO to substrate. Sumoylation is critically implicated in multiple biological processes, including cell proliferation, differentiation, senescence and apoptosis, etc. Therefore, it is not surprising that dysregulation of sumoylation has been implicated in tumorigenesis and different types of cancer were found to be addicted to functional sumoylation pathway. The potential role for sumoylation as a therapeutic target in cancer is emerging. In this review, we summarize current knowledge regarding the involvement of sumoylation in genome stability and DNA damage response. We will further discuss the therapeutic potential of sumoylation as synthetic lethal partner and as a key signaling pathway in cancer stem cells.

(Emphasis mine)
https://www.ncbi.nlm.nih.gov/m/pubmed/28017138/
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investek
Posted on: Jul 26 2019, 02:47 PM


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Posts: 259

Precisely! I agree with the connection.

Below is another reference, credit to the original person who posted (probably Uho)

p53 sumoylation
Mechanistic insights from reconstitution studies
Shwu-Yuan Wu and Cheng-Ming Chiang

Abstract

Sumoylation represents a cascade of enzymatic reactions mediated by SUMO-activating enzyme (SAE1/SAE2 heterodimer), SUMO-conjugating enzyme Ubc9, and SUMO E3 ligases that include five protein inhibitors of activated STATs (PIAS1, PIAS3, PIASy, PIASxα and PIASxβ), and culminates in the formation of an isopeptide bond between the C-terminal glycine of a small ubiquitin-related modifier (SUMO) and the lysine residue of a protein substrate. Conjugation of a SUMO moiety, ranging from 92 (for SUMO-2) to 97 (for SUMO-1) amino acids, not only increases the molecular size but also alters the property and function of the modified protein. Although sumoylation has been observed with many cellular proteins and the majority of transcription factors including the p53 tumor suppressor, this covalent modification is normally detectable only in a small population, often less than 5%, of a given substrate in vivo. This low abundance of SUMO-modified proteins, due to the presence of sentrin/SUMO-specific proteases (SENPs) that actively cleave the reversible SUMO linkage, has posed a challenge to define the biological effect of SUMO in living cells. Nevertheless, the recent development of reconstituted modification and chromatin-dependent transcription assays has provided unique insights into the molecular action of SUMO in modifying protein function. The availability of these reconstitution systems has unraveled the interplay between sumoylation and acetylation in regulating the DNA binding and transcriptional activity of p53 tetramers and further allow the identification of transcriptional corepressors, such as mSin3A, CoREST1/LSD1 and Mi-2/NuRD implicated in SUMO-dependent gene silencing events.

Keywords: p53, SUMO, sumoylation, acetylation, chromatin, posttranslational modification, in vitro transcription
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4749140/
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investek
Posted on: Jul 24 2019, 03:35 AM


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https://www.fdanews.com/ext/resources/files...ing-Digital.pdf
Page 6

My expectations are tempered, nothing seems to happen quickly or easily with CUV...
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investek
Posted on: Jul 21 2019, 05:03 PM


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I’ve been thinking about Darren’s incentive to get CUV listed in another country (probably US, NASDAQ) and why this milestone was missed, or much more likely deferred to FY20.

The best I can come up with is that Wolgen has a plan/expectation to list on the NASDAQ in the best possible way and that probably means going straight for the NASDAQ Global Select Market, rather than a lower tier listing. From a quick look at the listing criteria I believe CUV will meet all necessary milestones for the top tier listing once the FY19 annual report is published. I may have overlooked something so please critique my (very quick) analysis.

Assuming the criteria for NASDAQ Global Select Market have now been met, the question is when will Wolgen want to list? After an FDA approval? This could/would drive a new wave of international ETF purchasing and may re-baseline/position the company on a global stage. Or does he list before approval and use the NASDAQ platform to get the message out about this hidden gem to the wider world?

Interested in your thoughts/views...

https://listingcenter.nasdaq.com/assets/initialguide.pdf
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investek
Posted on: Jul 19 2019, 08:23 AM


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@polyphemus is this something you can help with?

Is it possible to see which broker(s) have been selling down while the short interest has been increasing of late?

Thanks in advance.
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investek
Posted on: Jul 19 2019, 07:32 AM


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Posts: 259

Thanks Iggy, insightful post (the shorting part not Seeking Alpha reference), I have a couple of questions.

1) How do you know a (single) broker is shorting?
2) Which broker is it that is doing the shorting?

The biggest takeaway for me is that as the broker already has the right to lend out their client’s shares if they short these shares themselves they can do so without the usual borrowing costs associated with shorting (and without needing agreement from the holders to lend their shares).

I think there still could be a short squeeze in the near future with increased buying close to/after PDUFA and an upcoming dividend payment (that the broker will need to cover for the shares they’ve shorted).


QUOTE
Do You Know Where Your Securities Are Tonight?
Walter Cruttenden Apr. 19, 2011, 9:00 AM

In order for someone to short a security (sell stock that isn't theirs) they first need to "borrow" the shares.But who really wants to loan his or her securities to someone that is going to bet against them? After all, short sellers put pressure on the price of your stock, say bad things about your company on message boards, and generally hope that your investment will decline in value, so they can pay you back in "worth-less" securities. Knowing this, no intelligent investor would ever lend their securities to a short seller - so your brokerage firm does it for you.

What? My brokerage firm is loaning my securities to short sellers to bet against me without my knowledge? Yes, if you have a margin account with your brokerage firm you have signed a "hypothecation" agreement allowing that firm to put your shares up as collateral at a bank so they can borrow the funds they loan to you. Nothing wrong with that you say - but buried in the agreement is the blanket right for that brokerage firm to do just about anything it wishes with your securities as long as your loan is outstanding. This means if you own shares in a young biotech company that you are very excited about your brokerage firm can loan those shares (your shares) to anyone that wants to sell those securities short.

Cont’d...


https://www.businessinsider.com/do-you-know...ght-2011-4?IR=T
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investek
Posted on: Jul 8 2019, 01:15 AM


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Posts: 259

QUOTE
Biotech Daily
July 1, 2019


June 30 marked a 13-year reckoning for the Biotech Daily Top 40 Index (BDI-40)*, up 220.8 percent on the raw collective market capitalization, and when adjusted for comings and goings like the ASX200, it was up 339.4 percent over the 13 years to June 30, 2019.

The ASX200 was up 30.4 percent over 13 years, but the collective market capitalization of the three Big Caps of Cochlear, CSL and Resmed (which are not included in the BDI-40) climbed a staggering 681.3 percent from just $17,156 million in 2006 to $134,039 million.

Four of the BDI-20 stocks have weathered the storms of 13 years and 10 of the BDI-40 have survived the distance.

Clinuvel is the 13-year best, up 2,484.6 percent from $65 million in 2006 to $1,680 million on June 30, 2019, with Mesoblast up 894.4 percent from $71 million to $706 million.

Polynovo joined the Billion Dollar Club in June, up 817.1 percent from the then Metabolic’s $111 million, to $1,018 million on June 30, followed by Starpharma up 310.6 percent to $518 million, Circadian-Opthea (288.4%), Neuren (202.6%) and Benitec (114.3%).

Others have not done so well. Pharmaxis has fallen 72.3 percent from $364 million to $101 million, Alterity-Prana improved just $1 million in 13 years to $25 million, Optiscan has fallen 43.4 percent to $27 million, with Antisense up 58.3 percent to $19 million.

Tenacious among the surviving demotions are several 2006 BDI-40 stocks including Acrux, Alchemia, Bionomics, Genetic Technologies, Living Cell, Phosphagenics (Avecho) and Phylogica.

For the year to June 30, 2019 the BDI-40 was up 40.3 percent, the Big Caps were up 12.8 percent, the ASX200 improved 6.8 percent and the NBI fell 0.7 percent.

The BDI-20 saw 16 companies up for the year, with just four falls. The Second 20 saw just five rises for the year and 15 falls.

Avita was the best of the BDI-20, up 792.0 percent from $88 million 12 months ago to $785 million, followed by Genetic Signatures (268.4%), Paradigm, (236.3%), Clinuvel (218.8%), Pro Medicus (213.8%), Polynovo (189.2%), Volpara (154.6%), Telix (110.1%), Nanosonics (77.9%), Opthea (57.5%), Cyclopharm (48.5%) and Starpharma (19.9%).

For the year to June 30, 2019, Neuren led the BDI-20 falls, down $184 million or 61.5 percent to $115 million, followed by Ellex (13.6%), Immutep (9.6%) and Cynata (2.3%).

For the month of June, 12 of the BDI-20 stocks were up, with five up by more than 10 percent and eight fell. The Second 20 had five up (four by more than 10 percent) and 13 fell, of which 11 fell by more than 10 percent.

On the Nasdaq, Vaxart (Biota) was unchanged at $15 million, Eyepoint (Psivida) was up 3.3 percent to $248 million, Queensland’s Protagonist was up 19.2 percent to $404 million and Israel’s Redhill with Australian assets was up 12.4 percent to $263 million. Cannabis Corner’s 18 companies slipped 2.7 percent despite the addition of two new companies.

Amplia and Resonance will replace Airxpanders and Reva in the Second 20.

* The BDI-40 is selected with the assistance of Lodge Partners analyst Marc Sinatra.


https://www.biotechdaily.com.au
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investek
Posted on: Jul 7 2019, 05:31 PM


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SSIEM Annual Symposium
Rotterdam | The Netherlands | De Doelen Conference Centre Committees
September 3-6 2019

https://ssiem2019.org/wp-content/uploads/20...nt-5-7-2019.pdf


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investek
Posted on: Jun 30 2019, 06:58 PM


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EP3288967 and EP3288966

EP3288967 - PHARMACEUTICAL COMPOUND
Status Grant of patent is intended
Status updated on 19.05.2019
Database last updated on 29.06.2019
https://register.epo.org/application?number=EP16729054

EP3288966 - PHARMACEUTICAL COMPOUND
Status Grant of patent is intended
Status updated on 10.06.2019
Database last updated on 29.06.2019
https://register.epo.org/application?number...39&tab=main

https://patentscope.wipo.int/search/docs2/w...uCcz4D94eEfHgz4

https://patentscope.wipo.int/search/docs2/w...XPAZj0-9i0PuSJI
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investek
Posted on: Jun 30 2019, 06:36 PM


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Posts: 259

Looks like some good news on the horizon for the Vallaurix new molecule/hexapeptide!
https://register.epo.org/application?number...39&tab=main

In contrast to the struggles / road-blocks getting a similar patent granted in the US it appears a European grant could be only months away. I have no idea how this may impact further US or other global patent claims however I believe it could only strengthen the case.

Now we just need the evidence that this new molecule works as claimed, Vallaurix OTC topical anyone?




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investek
Posted on: Jun 19 2019, 03:55 AM


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https://yourir.info/resources/fee77b1d1a878...cial_Report.pdf
Page 18
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investek
Posted on: Jun 9 2019, 11:39 AM


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Sunday Stock Review - CUV
https://m.youtube.com/watch?v=v7zwztrnEkQ
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investek
Posted on: May 28 2019, 01:33 AM


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The British Porphyria Association’s (BPA) first ever Irish Conference will be held in Dublin on Sunday 23 June 2019.

https://www.eventbrite.co.uk/e/irish-porphy...ets-62199550530

The meeting is being organised with the support of Dr Crowley, Ms Brazil, Dr Sarkany and Dr Badminton. Orphan Europe have also kindly provided a grant to support us.
The Ashling Hotel venue is a 20-minute walk/5-minute tram ride from Dublin’s city centre. Heuston Intercity Railway Station is a 2-minute walk away. If travelling by car, the M50 motorway is close and there is multi-storey parking available at the hotel.

A DRAFT programme of content is detailed below to include: doctor talks, patient testimonials and lots of opportunities to speak with others affected by porphyria.
The conference is free to attend, but please book your place(s) now. The BPA have a limited travel bursary available to help support people to attend. If you’d like to apply please contact Sue Burrell: sue.burrell@porphyria.org.uk.
Irish Conference 2019 - Programme
Dublin, Ireland
Ashling Hotel, Parkgate Street, Dublin 8, Ireland
Sunday 23 June 2019: 1200 – 1700


1200-1230 Registration and light lunch
1230-1250 Introduction to the porphyrias and the BPA – Sue Burrell
1250-1305 Testing for porphyria – Ms Brazil
1305-1330 Acute talk: Symptoms, diagnosis and condition management of the acute porphyrias – Dr Crowley
1330-1345 Drug development and access to new medicines – Stephen Lombardelli (Alnylam Pharmaceuticals)
1345-1410 Symptoms, diagnosis and condition management of the cutaneous porphyrias – Dr Sarkany
1410-1425 Clinuvel UK Ltd: Intro to a treatment for EPP – Lachlan Hay (Clinuvel UK Ltd)
1425-1500 Refreshment break
1500-1520 AIP patient experience talk: A family case study of AIP – Liz Gill
1520-1540 EPP patient experience talk: An EPP patient story – Antony Fearn
1540-1610 New treatments/therapies and the future for porphyria – Dr Mike Badminton
1610-1630 Questions and answer session with the panel of speakers from the day
1630-1700 Refreshments and informal discussions
Please note: the exact content may change slightly, but the main timings of 1200 to 1700 will remain unchanged.
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investek
Posted on: May 21 2019, 10:44 AM


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Wolgen began using the term “loco-regional” at the last AGM, and this was in reference to the topicals, he also mentioned bio-mimicry (a topical that would only stimulate melanogenisis where applied, the same way we only tan on skin that is exposed to the sun).

Wolgen also mentioned a little about the differences between CUV9900 and VLRX001 a few years ago.
- CUV9900 for photoinduced skin disorders (perhaps PunkassDerm could elaborate on the full spectrum of relevant conditions)
- VLRX001 for complementary topical treatment in vitiligo

https://www.asx.com.au/asxpdf/20181121/pdf/...hbj4p2nx7vc.pdf

https://www.asx.com.au/asxpdf/20141128/pdf/...3j3zkx8n04n.pdf

https://www.asx.com.au/asxpdf/20151124/pdf/...78f6hzwd6v9.pdf
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investek
Posted on: Apr 21 2019, 02:18 PM


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It looks like afamelanotide has made it onto Finland’s list of medicinal products. I’m not 100% sure what this means in terms of access/state reimbursement, it might be worth giving the main EPP expert centre in Finland a call, Helsinki University Central Hospital. Do we have any Finnish speakers on the board?

https://www.finlex.fi/fi/laki/kokoelma/2019/sk20190415.pdf

I appreciate there are probably only a handful of people suffering from EPP in Finland (28?, assuming 1:200,000 and a population of ~5.5mil), however every new country providing treatment is a step forward and potentially a new life without pain for those receiving treatment!
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investek
Posted on: Apr 3 2019, 09:47 AM


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I haven’t been able to find out too much about the Goldman Sachs investor conference that Clinuvel will present at today/tomorrow however there is a little bit of info in the Starpharma Announcement below.

QUOTE
Starpharma will today present to institutional investors at the Goldman Sachs Tenth Annual Emerging Companies conference in Sydney.

The invitation-only Goldman Sachs Conference brings together around 40 ASX listed companies over a two day event with approximately 100 investors ranging from specialist small and mid-cap, to large cap funds including a number of offshore investors.


https://www.asx.com.au/asxpdf/20190403/pdf/...0lqtxcsy6r7.pdf
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investek
Posted on: Mar 20 2019, 09:43 AM


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Newsletter out
https://www.asx.com.au/asxpdf/20190320/pdf/...mvqv42wmsdd.pdf
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investek
Posted on: Mar 20 2019, 01:11 AM


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Nice find Verharven, thanks!

My initial thoughts went straight to ‘prep for NASDAQ listing’ however the more I think about it I don’t believe Clinuvel will raise capital when going for a full NASDAQ listing. There is already cash coming in and potentially more to be gained by keeping the register tight and increasing the FOMO.

So my revised hypothesis is that this is a web portal where changes in substantial holdings can be lodged (perhaps with combined access for Clinuvel, major investors and the ASX?)

My theory is loose and based on seeing similar terminology used by SomnoMed, see below.
https://somnomed.com/en/about-us/asx-invest...orm-603_090915/

With the recent high trading volumes I wouldn’t be surprised to see a Form 603 (Notice of Inital Substantial Holder) lodged soon regardless.

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investek
Posted on: Mar 19 2019, 07:35 AM


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Extremely thankful!

Coincidentally(?) Scenesse may be therapeutic in diabetic retinopathy...
Credit to Uho for the info below.

QUOTE
Α-Melanocyte-Stimulating Hormone Protects Early Diabetic Retina from Blood- Retinal Barrier Breakdown and Vascular Leakage via MC4R
Conclusions: This study showed previously undescribed protective effects of α-MSH on inhibiting BRB breakdown and vascular leakage, improving electrophysiological functions and morphology in early diabetic retinas, which may be due to its down-regulating pro- inflammatory factors and augmenting tight junctions. α-MSH acts predominantly on MC4R to antagonize hyperpermeability in retinal microvessel endothelial cells.

https://www.karger.com/Article/Pdf/487029
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investek
Posted on: Mar 18 2019, 09:37 AM


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Best I could find was a total of 984.8k shares traded Friday down under.
Credit for this find goes to Raimondo2 on the German forum.
http://aktien.finanztreff.de/aktien_einzel...t.htn?i=7667518

Bloomberg showed a total of 708.5k shares traded and we know from past experience that their total includes both ASX and Chi-X.
https://www.bloomberg.com/quote/CUV:AU

My guess is that the additioonal ~275k shares were traded off-market after hours.

Appreciate anyone who can build on this, perhaps Polyphemus?
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investek
Posted on: Feb 26 2019, 10:38 AM


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Think you just stumbled upon the delayed minor ‘trading halt’ associated with the release of the price sensitive half yearly (as this was released after the market had already opened ~10:45am I believe).
https://www.asx.com.au/documents/public-con...nouncements.pdf
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investek
Posted on: Feb 14 2019, 09:33 PM


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My understanding is that CommSec will allow some degree of Margin Loan against CUV stock however not when holding the stock in isolation.

You would be required to hold a diversified portfolio (Portfolio LVR (5 or more securities with Standard LVR) plus your CUV stock and CommSec would allow a margin loan for 40% of the total value of your portfolio. I’m not sure what % each stock would need to represent for the portfolio to qualify as ‘diversified’ however I doubt 1 share of CBA, BHP, WES, WBC, & RIO + a tonne of CUV shares would qualify, you may need to contact CommSec directly.

FYI CUV has been listed like this for some time (6mths?), I’ve been monitoring it from time to time waiting for CommSec to give CUV a single/standard LVR.

From the pdf:
“Portfolio LVR (PLVR) is enabled in diversified portfolios with 5 or more securities with Standard LVR.”

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investek
Posted on: Feb 14 2019, 03:38 PM


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Posts: 259

I’d be supportive of a split for the reasons already mentioned below however it might not be as simple a decision as it seems...

I recall various NASDAQ market designations have particular requirements/thresholds for the share price, see below/link. For the top tiers I believe a bid price of $4 is required so this may not be considered until CUV trades consistently above $40 for some period (that said they could obviously choose to do a smaller split e.g. 5:1).
https://listingcenter.nasdaq.com/assets/initialguide.pdf

There is also the consideration of larger NASDAQ fees if a greater number of shares are on issue.

Regardless, I’m sure Wolgen and Keamy are all over this and have a plan (is addition to NASDAQ Global Select Market more important than a split? Do they wish to attract more Aussie punters or more US instos?), however as usual I don’t expect we will find out what that plan is until it is implemented.
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investek
Posted on: Feb 12 2019, 01:48 AM


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My educated guess is that the 50k vol figure is based on the CUV shares traded on the ASX and the 108k vol figure is based on ASX + Chi-X (CXA) trades.
https://amp.reddit.com/r/AusFinance/comment...ch_vs_cxa_chix/

The same thing happened when Blijdorp bought his 1.3mil CUV shares mid last year. The massive volume wasn’t reported via Yahoo finance (and other providers that only publish the ASX vol). Fortunately Polyphemus posted news of the large trade. I doubled checked at the time and sure enough the difference was volume traded on Chi-X. It’s not that easy to get access to this info as a retail investor, perhaps someone has an IRESS / IRESS Direct account or similar and can post confirmation of the volumes across both exchanges.
https://www.commsec.com.au/support/frequent...tions/396.html#

It would also be interesting to see which brokers are doing the buying and/or the changes in monthly Top 20 holdings (I believe some holders have asked for monthly top 20 data from CUV in the past but have been met with silence, might be worth asking Mr Bull in his new role as IR Manager). I wonder if an investment bank is trying to quietly build a position before suddenly commencing coverage with a BUY rating and much higher price target just months before a pending FDA decision. (Apologies, I’m getting carried away! Sounds too much like a conspiracy theory wink.gif )
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investek
Posted on: Feb 9 2019, 09:21 PM


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I’m confident that is an old analyst report.
https://www.yumpu.com/en/document/read/3708...pharmaceuticals

Note the date on the URL you posted and the date below.


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investek
Posted on: Feb 8 2019, 12:46 AM


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11.3 What happens after the appeal decision is published?
There is no possibility of further appeal against the decision of the Appeal Panel. However, this decision and NICE's decision to issue the final guidance may be challenged by applying to the High Court for permission to apply for a judicial review. Any such application must be made promptly and within 3 months of publishing the final guidance.

https://www.nice.org.uk/process/pmg18/resou...-72286661671621

And some text from a past High Court challenge
“For the avoidance of doubt, it was correct for you to allow the Institute’s appeal before initiating any judicial challenge,...”
https://www.nice.org.uk/guidance/TA111/docu...ing-high-court2
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investek
Posted on: Feb 7 2019, 08:00 PM


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Posts: 259

Today’s commentary on CUV from Newing and a photo of Najib Babul for those curious.

QUOTE
Thur 7 Feb - Trading portfolio
The portfolio slipped 0.1% today. Best were CUV +4% and VTG +5%. Worst were SAR -5% and BGL -4%. In the current environment gold stocks are under-performing compared with the banks and iron ore miners.

CUV ($23.45 up $1.00) has broken out! I included the charts in yesterday’s blog so won’t repeat them here, but it does look good.

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investek
Posted on: Feb 7 2019, 07:36 PM


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Awareness of CUV seems to be growing in the US...

San Diego Entrepreneurs Exchange (SDEE)
Erythropoietic Protoporphyria: An Unmet Medical Need for a Severe Photodermatosis
Najib Babul posted by NAJIB BABUL | 96
http://www.sdentrepreneurs.org/najibbabul/...photodermatosis

Najib Babul, PharmD, MBA is an accomplished pharmaceutical scientist, drug developer, inventor, and biotech entrepreneur with more than twenty years of experience in bringing new drugs to market
http://najibbabulnews.com

http://twitter.com/intent/user?screen_name=najibbabulrelma
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investek
Posted on: Feb 7 2019, 06:51 PM


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I’m no chartist or technical trader either however some bloke Graeme Newing seems to agree with you and Waz.

QUOTE
Tue 5 Feb - Trading portfolio
The portfolio rose 0.2% today. By far the best performer was CUV +6% followed by ATU +4%. Worst was BRB -4%.

The CUV price at $22.65 is now right on the downtrend line from the September top of $24.10. If it gets through this then it still has to get through $24.10. After that, the sky is the limit. Well, perhaps not the sky – just $41.50.


http://www.newingonstocks.com

Newing’s chart below.
http://www.newingonstocks.com/wp-content/u.../CUV-190205.png
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investek
Posted on: Jan 30 2019, 10:55 AM


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Thanks Johnny, Desert Rat, you both raise good points.

Johnny I agree, I’m yet to find any evidence of afamelanotide being able to successfully penetrate the skin via a topical. That said Clinuvel has been investigating this (and other formulations) since pre-2003 (see graphic below).
https://sec.report/Document/9999999997-04-025305/scanned.pdf

I have read some interesting articles regarding carriers/substrates that could enable large molecules to pass through the skin but again no hard evidence yet...

It’s also worth noting Madman’s avatar (see below). Remember the floating jar of Scenesse Topical in the jungle from that video (that was quickly removed) years ago?
Note: It is labelled ‘Scenesse’, (brand name of afamelanotide), perhaps I’m reading too much into it...

Desert Rat, I agree that what you outline is the quickest/easiest way to get Scenesse to the paediatric population, however using the paediatric trials as a platform for launching a new delivery method may be the quickest/easiest way to expand delivery mechanisms available for Scenesse. I have also heard concerns regarding the use of an implant in such young children and this may factor in to the development path taken.

Either way I see some exciting times ahead, looking forward to the next phase of development!
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investek
Posted on: Jan 30 2019, 08:38 AM


Group: Member
Posts: 259

I feel it’s worth reminding ourselves of the requirements of the EMA paediatric investigation plan for afamelanotide.

QUOTE
Paediatric Investigation Plan
2.1. Condition:
treatment of erythropoietic protoporphyria

2.1.1. Indication(s) targeted by the PIP
Treatment of erythropoietic protoporphyria

2.1.2. Subset(s) of the paediatric population concerned by the paediatric development
From 2 years to less than 18 years of age.

2.1.3. Pharmaceutical form(s)
Implant
Age appropriate prolonged release formulation

2.1.4. Studies

Quality
Study 1.
Development of age appropriate prolonged release formulation for subcutaneous use.

Non- clinical
Study 2. Juvenile repeat-dose toxicity study in rats followed by 4-week recovery.

Clinical
Study 3. Comparative study to evaluate the pharmacokinetics of afamelanotide and the pharmacodynamic response to afamelanotide between subcutaneous administration of solid implant and the age appropriate prolonged release formulation in healthy adults.

Study 4. Open-label, multicentre, multiple dose, dose-escalation pharmacokinetic and pharmacodynamic study of afamelanotide age appropriate prolonged release formulation in children from 6 to less than 18 years with erythropoietic protoporphyria.

Study 5. Open-label, multicentre, multiple dose, dose-escalation pharmacokinetic and pharmacodynamic study of afamelanotide age appropriate prolonged release formulation in children from 2 to less than 6 years with erythropoietic protoporphyria.

Study 6. Placebo controlled, randomised, double-blind safety, pharmacodynamics and efficacy trial of afamelanotide age appropriate prolonged release formulation in children from 6 to less than 18 years with erythropoietic protoporphyria, and with an open-label active-only arm in children from 2 to less than 6 years, with 12 month open-label extension to evaluate safety.

Date of completion of the paediatric investigation plan:
By June 2022

https://www.ema.europa.eu/documents/pip-dec...granting_en.pdf

I’m hopeful that we hear something this calendar year regarding the new formulations and progress made towards achieving the paediatric investigation plan. In a few months it will be June and that leaves just 3 years for all the studies above to be completed (and we are all familiar with the length of time it has taken to get study results in the past...)

The BiotechDaily excerpt below is from 2014 and may shed some light on what we can hope to hear from Clinuvel/Vallaurix this year...
QUOTE
Clinuvel says it will create a joint venture with Biotech Lab Singapore, to be called Vallaurix, to complete development of topical paediatric afamelanotide and CUV9900. Clinuvel said that 16mg afamelanotide or Scenesse was under European regulator review and CUV9900 was “a novel melanocortin peptide for topical application for skin care”. Clinuvel said it retained a majority interest in the partnership, but did not disclose the financial terms and said it would lead and oversee the scientific aspects including the regulatory development of the melanocortins, with Biotech Lab Singapore managing chemistry and formulation development in Asia.
Clinuvel said that the clinical use of Scenesse over the past decade provided specific knowledge of the clinical use and safety of melanocortins in dermatology and feedback from the European Medicines Agency’s regulatory review “played an important role in the timing of the joint venture’s establishment”.
The company said Vallaurix would develop the paediatric formulations of afamelanotide for erythropoietic protoporphyria as well as CUV9900 to be used as a complementary therapy in photodermatoses and depigmentation disorders such as vitiligo.
Clinuvel said that subject to a positive European regulatory outcome for Scenesse in October 2014, the formulations for paediatric use would be developed to stay within the timelines committed to the European Medicines Agency.
Clinuvel acting chief scientific officer Dr Dennis Wright said that in view of the progress of Scenesse, it was time to advance new formulations for paediatric use in [erythropoietic protoporphyria] and CUV9900 for the complementary treatment of skin disorders”. Clinuvel chair Stan McLiesh said that “for years, the board has strived to realize the vision of furthering the development of Scenesse into complementary treatments.”

http://www.biotechdaily.com.au/media/backi...%20Sep%2019.pdf
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investek
Posted on: Jan 23 2019, 06:23 PM


Group: Member
Posts: 259

Public info from FT site indicates ~36mil shares, not sure how accurate this is...

https://markets.ft.com/data/equities/tearsh...mmary?s=CUV:ASX


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investek
Posted on: Jan 16 2019, 09:25 AM


Group: Member
Posts: 259

Let me reiterate what Farma and Magyver have already said.

There will be no off-label availability of SCENESSE with FDA approval (At least not for many many years).

Wolgen will not risk what he has taken so long to build. Clinuvel control distribution and will not provide SCENESSE outside the expert centres and approved indications. We are starting to learn a little more about the other indications Wolgen has in mind. IMO we will see a controlled, methodical expanded use, probably through many more smaller trials (initially e.g. VP, recently announced) and then larger trials probably linked to formal label extensions e.g. Vitiligo (where this has been previously discussed/agreed with the FDA). Similar to Farma I’m concerned about how quickly these label extensions are pursued however I feel we need to trust Wolgen, he’s taken us this far.

Way way way down the track (once all additional/non-standard risk monitoring obligations have been removed) you may see some off-label availability however in the near term I don’t think it’s worth speculating about. Probably better to spend the energy imagining what the new products, formulations and OTC products could be.
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investek
Posted on: Jan 11 2019, 09:55 AM


Group: Member
Posts: 259

There is some good info in the attached presentation however some of the stats provided are for New Molecular Entities only.

https://www.fda.gov/downloads/AboutFDA/Cent...R/UCM628150.pdf
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investek
Posted on: Jan 10 2019, 12:57 PM


Group: Member
Posts: 259

Only thing I can think of is that an Advisory Committee meeting is not required because of the additional information gained via the Scientific Workshop on Erythropoietic Protoporphyria (EPP) held by the FDA back in 2016. Several experts presented (inc. Dr Minder) as well as numerous patients and FDA reps were present. Perhaps the workshop meets/exceeds the advice/info normally gleaned from an advisory committee?

QUOTE
What is an FDA Advisory Committee?
Advisory committees provide FDA with independent advice from outside experts on issues related to human and veterinary drugs, vaccines and other biological products, medical devices, and food.
In general, advisory committees include a chair, several members, plus a consumer, industry, and sometimes a patient representative. Additional experts with special knowledge may be added for individual committee meetings as needed. Although the committees provide advice to the agency, FDA makes the final decisions.

https://www.fda.gov/AboutFDA/Transparency/B...s/ucm222191.htm

FDA News and Events - Scientific Workshop on Erythropoietic Protoporphyria (EPP)
https://www.fda.gov/drugs/newsevents/ucm501389.htm

Slides from Scientific Workshop on Erythropoietic Protoporphyria (EPP)
https://www.fda.gov/downloads/Drugs/NewsEvents/UCM580428.pdf
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investek
Posted on: Jan 10 2019, 09:46 AM


Group: Member
Posts: 259

And the FDA does not intend to hold an Advisory Committee meeting!

This is a surprise to Clinuvel also, recall Wolgen’s statements at the AGM and see Dr Wright’s comment below!
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investek
Posted on: Jan 7 2019, 04:38 PM


Group: Member
Posts: 259

Seems Clinuvel is starting to gain more coverage/visibility in the US...

Recent Tweet from Ron Leuty (biotech and sports business reporter in San Fran) “Clinuvel is a Australian company with US HQ in Menlo Park …
Coming out of the shadows: A new treatment may help people who are ‘allergic’ to the sun”
https://twitter.com/sfbizronleuty/status/10...8539213824?s=21

I wonder if Clinuvel/Wolgen will be attending or presenting at the 37th JP Morgan Healthcare conference? #JPM19 Is anyone from this board attending?

There are several events where Clinuvel or Wolgen could be mentioned/appear.

RECEPTIONS AND PRIVATE EVENTS |
Monday, January 7th
3:45pm - 4:30pm Ausbiotech: Capitalising on the Strengths of the Australian Bio-Economy
4:30pm - 5:30pm Ausbiotech: International Delegation Reception

Tuesday, January 8th
8pm - 12am Oppenheimer & Co Inc Cocktail Reception
(Investor in CUV)

Wednesday, January 9th
6:30pm - 8:30pm Columbia Business School - San Francisco: Alumni Reception at the J.P. Morgan Healthcare
(Wolgen’s alma mater)

http://go.bio.org/rs/490-EHZ-999/images/On...uide_121318.pdf
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investek
Posted on: Jan 4 2019, 11:30 AM


Group: Member
Posts: 259

Based on recent data the odds look better than even.

Since 2013 nearly 75% of Orphan Drug Approvals received a priority review designation.

https://www.fda.gov/downloads/forindustry/d...s/ucm581335.pdf
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investek
Posted on: Jan 2 2019, 11:50 AM


Group: Member
Posts: 259

Pretty sure it’s vitiligo...
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investek
Posted on: Jan 2 2019, 09:54 AM


Group: Member
Posts: 259

Good pickup Iggy!

Pic below shows vitiligo still apparent on the lady’s neck.

Taking on-board PunkassDerm’s comment of the face responding better and re-reading the study details provided by Farma it seems that for Patient/Case #3 “The treatment phase ended with the patient receiving an overall improvement of nearly 50%” so it was not totally curative, nor a full repigmentation response.
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investek
Posted on: Dec 31 2018, 08:22 PM


Group: Member
Posts: 259

Thanks Farma, nice find.

A couple of things stood out to me.

1. The article (and previous press releases) state the first objective as “to test whether a month’s treatment regimen would produce follicular repigmentation through the induction of dermal stem cells”, I can’t see any comment on whether this was achieved or not so I’m guessing it was not.
2. Re-pigmentation seems to have held for 3 months after the end of the trial but considering we have waited what, 4 years now? for these results I would have really appreciated some data on how re-pigmentation looks after 1, 2 or 3 years... I’m sure they have this info, just really disappointing that it hasn’t been released.

As Mauricinho mentioned in an earlier post, moving to open label basically takes any statistical significance out of these results however if data had been released regarding number of patients where re-pigmentation had held after 1, 2 or 3 years we may have been able to deduce some statistical significance in the combination treatment vs NB-UV alone and have something to get excited about.

For now I am taking comfort in Dr Grimes statement “We are observing similar efficacy results following the use of afamelanotide as we have found from the CUV102 study conducted in 2011-2012 in North America” and from the patient comment at ~7:48 in the video below, paraphrasing “I participated in a study and they stayed... they remained my colour... yay... for at least 3 years now”

https://m.youtube.com/watch?v=iqM0mKCFwcw
(I can’t recall who initially found and posted the YouTube video but credit to you, great find and thanks!)

Thanks again to all who have posted such valuable info this year and in the past, it is much appreciated!

Wishing everyone a safe and happy New Year’s celebration and a healthy and prosperous 2019!
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investek
Posted on: Dec 24 2018, 05:05 PM


Group: Member
Posts: 259

Perhaps some transactions were on the Chi-X and impacted the (strange) 205% figure?

Notes below from Shortman site, emphasis mine. https://www.shortman.com.au/credits

QUOTE
NOTES ON DATA

Data on this site is sourced from ASIC, ASX and other third party data providers. The short sales data is reliant on accurate report submissions by individual sellers. While ASIC monitors the compliance of reporting, there can be no guarantee as to the accuracy of these individual reports. The ASX data is published daily and the ASIC data is published 4 trading days after reported (T+4), so graphs on this site will be dated at least 4 trading days ago. If no position is reported for a particular stock, this site assumes zero shorted stocks.

Recent short sales data is sourced from ASX, and represents reported short positions. There is also no guarantee as to the accuracy of this data. These short sales include both ASX and Chi-X short sales. The trading volume is only the ASX trading volume, and the "Shorts as % of volume" is a simple division between these two figures. As Chi-X volume is not accounted for, it may not be accurate.
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investek
Posted on: Dec 23 2018, 09:59 PM


Group: Member
Posts: 259

Looks like a new (well amended previously granted) patent application has been published on 20 Dec 2018. (Patent Publication Number 20180360919)
(For reference this is a link to the previously granted patent by the same name https://patents.justia.com/patent/10076555)

QUOTE
METHODS OF INDUCING MELANOGENESIS IN A SUBJECT

Abstract
Described herein are methods and compositions for inducing melanogenesis in a human subject. The method comprises administering to a subject an alpha-MSH analogue, in an effective amount and time to induce melanogenesis by the melanocytes in epidermal tissue of subject without inducing homologous desensitization of the melanocortin-1 receptors.


http://appft.uspto.gov/netacgi/nph-Parser?...=DN/20180360919

https://patents.justia.com/patent/20180360919
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investek
Posted on: Dec 23 2018, 01:09 PM


Group: Member
Posts: 259

Clinuvel’s take on the 12 days of Christmas, as a social media campaign.

Seems both Instagram and twitter have the #12daysofskin content, and seems a few other companies tried to copy the concept.
Interesting that followers are growing on both platforms Insta ~4,000+ and Twitter ~1,100+

https://www.instagram.com/clinuvel_pharmaceuticals/?hl=en

https://mobile.twitter.com/ClinuvelNews?ref...7Ctwgr%5Eauthor
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investek
Posted on: Dec 14 2018, 08:54 PM


Group: Member
Posts: 259

Fair point Verharven, thanks for pointing out my oversight/sloppy language.

For completeness, this quarter S&P/ASX 200 Index – No change.

And for those interested in the specific differences between the indexes mentioned;

The S&P/ASX 200 is recognized as the institutional investable benchmark in Australia. Index constituents are drawn from eligible companies listed on the Australian Securities Exchange. The S&P/ASX 200 is designed to measure the performance of the 200 largest index-eligible stocks listed on the ASX by float-adjusted market capitalization. Representative, liquid, and tradable, it is widely considered Australia’s preeminent benchmark index.
https://au.spindices.com/indices/equity/sp-asx-200

The S&P/ASX All Australian 200 (AUD) Index follows the same methodology with respect to market capitalization and liquidity that are applied to the S&P/ASX 200 with one distinguishing characteristic - the rules do not extend index eligibility to foreign domiciled securities listed on the ASX. This allows the S&P/ASX All Australian Indices to be more fully representative of the characteristics of Australian listed companies.
https://au.spindices.com/indices/equity/sp-...-australian-200

October 2018 Foreign Entity Data can be found in the link below
https://www.asx.com.au/documents/resources/...t-20181031.xlsx
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investek
Posted on: Dec 14 2018, 09:52 AM


Group: Member
Posts: 259

As you predicted Waz, CUV has fallen short of inclusion in the ASX200 this rebalance.
https://www.asx.com.au/asxpdf/20181214/pdf/...6z7xvngbz8v.pdf

Interesting to note that Cooper Energy COE(ASX) was added with a current market cap of ~$700mil (vs CUVs ~$850mil market cap today). I haven’t run the numbers however I believe liquidity could be the difference with COE almost twice as liquid as CUV?

Let’s see what happens in March...
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investek
Posted on: Oct 31 2018, 02:49 PM


Group: Member
Posts: 259

I spose it’s no real surprise that Clinuvel / Dr Wolgen weren’t recognised at the AusBiotech and Johnson & Johnson Innovation Industry Excellence Awards today. I guess CUV will continue to fly under the radar in Australia...

AusBiotech’s Chief Executive Officer, Lorraine Chiroiu, said: “The annual Awards are an opportunity to recognise outstanding contributions to the sector, for which we are very grateful, as they demonstrate what is possible when vision and dedication come together.”

This year the Awards received an overwhelming number of emerging company nominations, demonstrating the positive Australian environment our life sciences companies are working within. For the first time ever, joint-winners are being awarded for this category.

Industry Leadership Award: Dr Anna Lavelle
Company of the Year: Medicines Development for Global Health
Joint Emerging Company of the Year: Telix Pharmaceuticals and Microba

https://www.ausbiotech.org/news/biotechnolo...cellence-awards
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investek
Posted on: Oct 27 2018, 09:01 AM


Group: Member
Posts: 259

From Twitter

On 13 November CLINUVEL will be presenting at the Bio Connections Australia Conference in #Melbourne. Stay tuned and learn more about it here: http://bit.ly/2pIDbEr

QUOTE
11:15 AM
SCENESSE®: an Australian Success Story | A First-in-Class NME Addressing Unmet Clinical Need
Nicoletta Muner, Director, Global Regulatory Affairs, Clinuvel Pharmaceuticals Ltd

Moderator: David Fuller, SVP Clinical Development Oncology, Syneos Health
- Afamelanotide: a first-in-class melanocortin-1 receptor agonist
- Novel clinical use in photoprotection and repigmentation
- Clinical development, regulatory pathways and post-authorisation management in EPP, a neglected orphan disease
(EU marketing authorisation in 2014, US NDA filed in 2018)

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investek
Posted on: Oct 22 2018, 12:44 AM


Group: Member
Posts: 259

Attendees List – 5th Annual Pharmacon Asia
- Clinuvel Pharmaceuticals
- Vallaurix

The conference has already happened 19-20th Sept 2018, however it is interesting to see representation from both Clinuvel and Vallaurix.
https://www.ibc-asia.com/event/pharmacon-asia/#close
https://www.ibc-asia.com/attendees-list-pharmacon-asia/

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investek
Posted on: Oct 22 2018, 12:12 AM


Group: Member
Posts: 259

Still some hope in Scotland?

QUOTE
Health Secretary outlines new pathway for medicines.

Patients with very rare diseases could get faster access to new treatments following a revised decision making process.

The Scottish Government is introducing a new definition of 'ultra-orphan medicines' that can treat very rare conditions affecting fewer than 1 in 50,000 people - around 100 people or less in Scotland. The new definition also allows the Scottish Medicines Consortium (SMC) the ability to treat some medicines for rare orphan diseases as ultra-orphan medicines.
The changes mean if the medicine meets the new definition of an ultra-orphan medicine and the SMC consider it clinically effective, then it will be made available on the NHS for at least three years while information on its effectiveness is gathered.

https://news.gov.scot/news/treatments-for-rare-conditions

QUOTE
8 October 2018
Revised process for ultra-orphan medicines

Following the Scottish Government's announcement around a new pathway in June 2018, a new approach to the assessment of ultra-orphan medicines is being introduced.

Revised process - ultra-orphan medicines for extremely rare conditions
A new approach to the assessment of ultra-orphan medicines is being introduced, in line with the Scottish Government announcement in June 2018 on a new pathway.

To be considered as an ultra-orphan medicine all criteria listed should be met:

The condition has a prevalence of 1 in 50,000 or less in Scotland,
The medicine has an EMA orphan designation for the condition and this is maintained at time of marketing authorisation,
The condition is chronic and severely disabling and
The condition requires highly specialised management.
Submissions for medicines that are validated as ultra-orphan according to this definition will be assessed by SMC and will then be available to prescribers for a period of at least three years while further clinical effectiveness data are gathered. After this period SMC will re-assess the data and make a final decision on routine use of the medicine in NHSScotland.

New ultra-orphan pathway
1. Validation as ultra-orphan medicine
In order for SMC to validate a medicine as ultra-orphan, companies are encouraged to provide relevant supporting evidence before receiving a Committee for Human Medicinal Products (CHMP) opinion. In addition, when we contact companies following a CHMP positive opinion, we will ask the company to indicate whether a medicine is expected to meet the ultra-orphan definition and complete a proforma (if not previously received).

We will then proceed with validation and confirm eligibility for the ultra-orphan pathway before the company makes a submission. The validation process is expected to take around six weeks. This validation process is now in place (October 2018).

We will contact companies with the outcome of the validation and, in the case, of disagreement, there will be an opportunity for the company to appeal.

2. Initial SMC assessment
Companies are encouraged to submit for the initial assessment using the SMC ultra-orphan framework. Further information on the submission requirements will be provided following engagement with the pharmaceutical industry, patient groups and other key stakeholders.

Note: submissions for medicines identified as ultra-orphan according to the current definition will continue to be assessed using the existing ultra-orphan process. To ensure that these ongoing submissions are completed before the new approach is introduced, future submissions will be assessed using the new ultra-orphan pathway from April 2019.

https://www.scottishmedicines.org.uk/how-we...are-conditions/
https://www.scottishmedicines.org.uk/about-...phan-medicines/

Status: still blank
Advice due date: TBC
https://www.scottishmedicines.org.uk/medici...fullsubmission/
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investek
Posted on: Oct 15 2018, 10:44 AM


Group: Member
Posts: 259

OK, so who put in the sell order for 6,250 shares at $90!
  Forum: By Share Code

investek
Posted on: Oct 8 2018, 02:05 AM


Group: Member
Posts: 259

Dear ShareScene CUV readers,

I have a challenge for all long term holders and readers of this board. From the true-believers/Clinuvelians to the trolls and plants, I think we all have an opportunity (and duty) to give something back.

By my calculations we collectively represent between 5-10% of the CUV share register and later today we will receive an unexpected maiden dividend.

My challenge to you all is to donate (at least) the value of your dividend payment to the American Porphyria Foundation, I believe collectively we can raise over $50k for Desiree Lyon and the APF!

As Stan stated in his letter, all long term holders have now done well and if/when the FDA finally approves SCENESSE we will all have a great debt to Ms Lyon, the APF and all the Porphyria patients that volunteered for the trials over the years. (We already owe them of debt for all the work they did in support of SCENESSE getting approval in Europe)

I know we all value our privacy and I think the best option is to donate directly to the APF via their website, see link below. One suggestion is that we all include the text ‘Desiree Lyon - ShareScene CUV’ in the Donating in Honor Of section so we can measure the overall impact of the board.
http://www.porphyriafoundation.com/content...yria-foundation

——
Johnny thanks for the prompter a couple of weeks ago, it is great to see you leading by example!

I had planned to do something like this 12-18 months ago however I was still trying to accumulate. I now feel there is no longer any excuse to delay and I have finally made my overdue donation!

Thank-you Desiree Lyon and the team at APF. I hope all EPPers can soon experience sunlight without pain!
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investek
Posted on: Sep 28 2018, 10:59 AM


Group: Member
Posts: 259

Speaking of trademarks (and potential infringement), your post reminded me of the pending re-registration of the CLINUVEL wordmark in the US. Looks like that’s all taken care of now with the mark registered on Sept 18, inc. many additional goods and services added (e.g. anti-aging moisturisers and another line mentions veterinary purposes!)

http://tmsearch.uspto.gov/bin/gate.exe?f=s...4810:kv5iyr.1.1


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investek
Posted on: Sep 23 2018, 02:14 AM


Group: Member
Posts: 259

Opps! I omitted the recent addition to the ASX300, perhaps others can include in their submissions.
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investek
Posted on: Sep 23 2018, 01:42 AM


Group: Member
Posts: 259

To make it easy for everyone I have attempted to draft a comprehensive summary (below) that can be copied or paraphrased in your submissions.
To my knowledge a nomination just needs to be sent to the following email address events@ausbiotech.org before Friday 28th September.

Perhaps we could use the 'thanks' feature on this post to keep track of how many people make a submission?

The text below is tailored for Wolgen and the Industry Leadership Award, however it should be easy to adapt for the Australian Company of the Year nomination.
It's just under the 400 word limit (399), happy for others to tweak or highlight anything I've missed.

Industry Leadership Award - I would like to nominate Dr Philippe Wolgen of Clinuvel Pharmaceuticals for the AusBiotech and Johnson & Johnson 2018 Industry Excellence Awards in the category of Industry Leadership.

QUOTE
Dr Wolgen has worked tirelessly for the last 13+ years to bring Clinuvel's drug SCENESSE® (afamelanotide) to market as the first therapy for patients with the rare disorder erythropoietic protoporphyria (EPP). In 2014 following the longest ever regulatory review by the European Medicines Authority, Clinuvel received marketing authorization and in 2016 the product was launched in Europe.

Dr Wolgen has achieved what two earlier management teams (and 12 prior years of effort) could not, bringing the world’s first systemic photoprotective agent to market!

I would like to highlight several factors why Dr Wolgen deserves this award:
• One of few Australian pharmaceutical companies to bring a new molecular entity to market!
• Sacrificed much personal life, including 50+ days of annual leave
• Disciplined financial management 2005-2018, Clinuvel has zero debt and has minimized shareholder dilution (Dilution 2005-17 = 187%)
• Total funds committed to SCENESSE® program to date: A$172m (<25% industry standard development costs)
• Maintained an Australian head office whilst globalizing the business and attracting a diverse share register ~equal representation in Australia, Europe and North America
• Recently completed the submission of a New Drug Application for SCENESSE® for EPP in the United States
• Staved off an opportunistic hostile takeover attempt in 2014
• Pioneered a new drug delivery mechanism for SCENESSE®, sustained released subcutaneous implant, leading to fewer and less severe side effects
• Introduced uniform pricing to help facilitate fair and equitable access to the drug, (Dr Wolgen presented to the final arbitration in German, not his native tongue)
• Profitable since 2017, first dividend declared 2018
• 66.1% increase in patient treatments 2016 to 2017
• 98% treatment continuation rate reported in EU/CH
• US patients flying to Switzerland to seek treatment
• Maintained a team of ~30 key staff for over 10yrs that have delivered amazing results

The following quotes from Chairman Stanley McLiesh, support my nomination of Dr Wolgen for this award.

“Having worked with previous executive teams, and certainly at CSL one led by one of Australia’s greatest CEOs, I have come to appreciate up close the efforts and accomplishments of our current CLINUVEL management against significant odds and challenges.”

“As a Board we are privy to key management decisions, and it has become obvious to us, and those with a standing in the sector, that Dr Wolgen’s intelligence, vision and forthright manner will succeed where others may well have walked away. This approach has taken CLINUVEL to the success it enjoys today.”


I think Clinuvel/Wolgen getting one of these awards would be a great thank-you from all of us who have been invested long-term for all the hard work Wolgen and the team have put in over the years!

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investek
Posted on: Sep 22 2018, 09:06 PM


Group: Member
Posts: 259

Seeing as though it now seems okay to do a bit a marketing about Clinuvel what does everyone think about the following?

Should we blitz them with nominations in the next 6 days?

Wolgen for the Industry Leadership Award (13yrs+ plus turning around a little known Aussie biotech, bringing the world’s first systemic photoprotective drug to market! Treatment for an ultra small patient population and a disease many don’t even know exists)

Clinuvel for Australian Company of the Year (As above plus 2 years of profitability, one of very few Aussie biotech companies to bring a new molecular entity to market, recent addition to the ASX300)

QUOTE
Each year, the Johnson & Johnson Innovation Industry Excellence Awards are presented at the AusBiotech national conference to recognise the highest achievers in the Australian life sciences. From researchers who successfully translate their discoveries to clinical practice, to companies who pioneer the developments of new treatments and reliable diagnostics, these prestigious Awards recognise the leading lights of Australia’s world-class biotechnology, medical technology and healthcare sectors.

Nominations are open until Friday 28 September 2018 in the following categories:

Industry Leadership Award
This award seeks candidates who have already made a significant difference to the industry and have an outstanding commitment to life sciences/biotechnology that often goes beyond the 'job description'. Candidates will be known for their passion, enthusiasm and commitment to the industry in Australia.

Australian Company of the Year
The Australian Company of the Year will be awarded to a company that has demonstrated significant achievement/s, and may include any company working in biotechnology or life sciences, including but not limited to the medical diagnostics or devices, pharmaceutical and agricultural biotechnology sectors. Criteria for companies may include deals done, product pipeline, IP, company strategy and/or revenue.

Australian Emerging Company of the Year
The Emerging Company of the Year award will be based on the same criteria as the previous category, but be specific to companies under five years of age.


Nomination Process
Nominations of up to 400 words are invited, outlining why the nominated individual/company should be awarded a Johnson & Johnson Innovation 2018 Industry Excellence Award, according to the applicable category and criteria. All applicants must be headquartered in Australia. Organisations with existing commercial interests owned by Johnson & Johnson or subsidiaries of Johnson & Johnson are not eligible. Staff/Board members and their associated organisations of Johnson & Johnson and AusBiotech are not eligible.

Please forward your nomination to the Events Team at events@ausbiotech.org
/ 03 9828 1400 or contact us if you have any queries.

http://www.ausbiotechnc.org/program-2/indu...cellence-awards
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investek
Posted on: Sep 22 2018, 04:32 PM


Group: Member
Posts: 259

Thanks odi01, Frogster, Verharven.

It’s a shame they got the pricing of the drug incorrect in the article, that’ll throw off any new-comers DCF models!
Note: It should read €14,000 per dose.

From the article
QUOTE
The company also expects to price the drug the same as the price in Europe, part of a strategy to be transparent on pricing. The drug is priced in Europe at €1,400 per dose and is dosed every 60 days, though the company said most patients receive three to four doses per year.
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investek
Posted on: Sep 21 2018, 03:20 PM


Group: Member
Posts: 259

https://starpharma.com/share_price_history
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investek
Posted on: Sep 21 2018, 01:11 AM


Group: Member
Posts: 259

Price to pay = follow up program? huh.gif

I’m confident there will be a follow up program in the US as part of any FDA approval, Clinuvel has asked for/suggested it!

QUOTE
A post-authorisation pharmacovigilance plan to monitor patients in the US long-term is part of the NDA submission.

https://www.clinuvel.com/investors/news/ite...esse-fda-filing
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investek
Posted on: Sep 18 2018, 11:38 AM


Group: Member
Posts: 259

I think the activity you are seeing is just a result of people (and bots?) trying to take advantage of the mechanism used to determine the opening price. The opening (and closing) auction can be a good opportunity to buy or sell a decent quantity of shares at a price you may struggle to find a match for once the market is open (assuming you don’t have access to Centrepoint the darkpool Johnny H mentioned previously).

For example this morning ~16k shares traded at $17.75 in the opening match and even now if you were to buy or sell a few thousand shares at market you’d likely drive the price up or down +/-20c.

The highest bids and lowest offers have the greatest chance of being included in the opening (and closing) matching process, and that may explain the wild fluctuations.

The links below provide a good explanation of the algorithm used in the matching process.
https://web.archive.org/web/20130127102638/...lose-prices.htm
https://www.rivkin.com.au/blog/shares/2017/...ions-24222.aspx
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investek
Posted on: Sep 13 2018, 01:34 AM


Group: Member
Posts: 259

Interesting that the CLINUVEL wordmark has been re-filed in the US.

Old Trademark
QUOTE
Word Mark CLINUVEL
Goods and Services
(CANCELLED) IC 003. US 001 004 006 050 051 052. G & S: Preparations for tanning the skin for use with sunlight or other ultraviolet light source, namely, suntan lotions and suntan oils; Preparations for tanning the skin without sunlight, namely, self-tanning preparations
(CANCELLED) IC 005. US 006 018 044 046 051 052. G & S: Pharmaceutical preparations for skin care; Biological and chemical preparations and reagents for medical or veterinary use; and Vaccines; Pharmaceutical preparations and drugs for the treatment of skin disorders; and Diagnostic preparations for medical use

http://tmsearch.uspto.gov/bin/showfield?f=...4807:kaitx7.3.2

New Trademark (application)
QUOTE
Word Mark CLINUVEL
Goods and Services
IC 003. US 001 004 006 050 051 052. G & S: Non-medicated skin care preparations; non-medicated skin care preparations, namely, cosmetics and cosmetic preparations for skin care, cosmetic preparations for skin care, based on analogues of melanocyte stimulating hormone, in particular afamelanotide, cosmetic nourishing creams, skin cleansing creams, skin lotions for cosmetic purposes, cosmetic sun protecting preparations, cosmetic preparations against sunburn, cosmetic sun protecting lotions, cosmetic sunscreen preparations, cosmetics for tanning the skin including preparations for tanning without sunlight, based on analogues, of melanocyte stimulating hormone, in particular afamelanotide, self-tanning preparations, suntan creams, cosmetic suntan lotions, cosmetic sun milk lotions; non-medicated skin rejuvenation preparations, namely, creams, lotions and cosmetic oils; non-medicated skin rejuvenation products, namely, creams, lotions and cosmetic oils with and without analogues of alpha-melanocyte stimulating hormone; anti-aging skin care preparations, namely, creams, lotions and cosmetic oils; anti-aging moisturizers used as cosmetics, non-medicated anti-aging serum; preparations for tanning the skin including preparations for tanning without sunlight
IC 005. US 006 018 044 046 051 052. G & S: Pharmaceuticals and pharmaceutical preparations for the treatment of skin disorders; pharmaceuticals and pharmaceutical preparations for the treatment of skin disorders, based on analogues of melanocyte stimulating hormone, in particular afamelanotide pharmaceuticals and pharmaceutical preparations for the treatment of damaged skin and tissue; pharmaceuticals and pharmaceutical preparations for the treatment of sunburn; pharmaceutical preparations for use in dermatology; pharmaceutical preparations for skin care; medicated skin care preparations; medicated sun tanning preparations; medicated sun tanning preparations for pharmaceutical purposes, based on analogues of melanocyte stimulating hormone, in particular afamelanotide; diagnostic preparations for medical purposes; chemical and biological preparations, substances, reagents and compounds, namely, pharmaceutical preparations for use in dermatology, for skin care, for the treatment of skin disorders, for the protection of the dermis and epidermis, all used in the manufacture, delivery and storage of pharmaceuticals, drugs and diagnostic preparations; vaccines; chemical reagents comprised of polyvalent compounds and synthetic molecules, for medical and veterinary purposes

http://tmsearch.uspto.gov/bin/showfield?f=...4807:kaitx7.2.1

The new trademark was ‘published for opposition’ 3rd July 2018 so I believe it should be fully registered soon.
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investek
Posted on: Sep 11 2018, 02:17 AM


Group: Member
Posts: 259

How CUV performs during a financial crisis is anyone’s guess. Historically I don’t recall a great degree of correlation between CUV and the overall market however I haven’t modelled this. A few people have mentioned that healthcare is not a bad sector to be invested in during a crisis however I do not have any data to back this up...

I’m no expert on financial crises however someone that is, Ray Dalio, has just released a new book that may help you navigate any upcoming debt crisis and he has very generously provided a link to a free PDF copy. Note: File size is huge ~70MB so will take some time to download

Ray Dalio’s new book
A Template for Understanding Big Debt Crises.
http://bit.ly/DalioRay
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investek
Posted on: Sep 10 2018, 01:13 AM


Group: Member
Posts: 259

I don’t think that Malek can be written off as a potential competitor. To quote Uho “Malek is a serious but way behind commercial and regulatory threat to Clinuvel”

That said, I thought it was interesting and potentially beneficial to Clinuvel that Malek’s article said
QUOTE
“This suggests that our peptides will not benefit individuals expressing loss-of-function MC1R, who have increased UV sensitivity and high risk for skin cancer and melanoma.”


It is my understanding that afamelanotide/Scenesse is effective in (at least two) MC1R variants, see extracts below

QUOTE
Afamelanotide, the first α-melanocyte-stimulating hormone (MSH) analogue, synthesized in 1980, was broadly investigated in all aspects of pigmentation because its activity and stability were higher than the natural hormone. Afamelanotide binds to the melanocortin-1 receptor (MC1R), and MC1R signaling increases melanin synthesis, induces antioxidant activities, enhances DNA repair processes and modulates inflammation. The loss-of-function variants of the MC1R present in fair-skinned Caucasians are less effectively activated by the natural hormone.


QUOTE
Two trials in human volunteers showed that neither MC1R variants nor fair skin reduced the afamelanotide-induced increase in skin pigmentation.

https://www.researchgate.net/publication/31...logic_Disorders

Caveat: I am no expert and these are just my thoughts/views (not advice).

I welcome the input of others more knowledgeable in this arena.

(I’m personally particularly interested in what Uho, royco, PunkassDerm and Farma make of all this.)
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investek
Posted on: Sep 8 2018, 07:32 PM


Group: Member
Posts: 259

Credit to Uhohinc for another great find! Thanks for your tireless efforts and willingness to share Uho, it’s greatly appreciated.
https://groups.google.com/forum/m/#!top...vel/F5lf_f0Ponw

MC1R: Front and Center in the Bright Side of Dark Eumelanin and DNA Repair
Viki B. Swope and Zalfa A. Abdel-Malek

http://www.mdpi.com/1422-0067/19/9/2667/htm

The following excerpts stood out to me.

QUOTE
Based on these findings, it can be concluded that expression of functional MC1R protects melanocytes against the genotoxic effects of UV by three mechanisms: (i) activation of DNA repair pathways (nucleotide excision and base excision repair pathways); (ii) inhibition of generation of reactive oxygen species, activation of antioxidant enzymes, and up regulation of expression of antioxidant genes; and (iii) increase in eumelanin synthesis (Figure 1) [35,76,78,79,80]. The first two mechanisms represent an early and immediate response to UV to prevent genomic instability of melanocytes, and the third is a latent response, which protects against the genotoxic effects of subsequent UV exposure.


QUOTE
The well-known effect of α-MSH on stimulating eumelanin synthesis and the photoprotective effect of eumelanin have sparked interest in developing melanocortin analogs as safe sunless tanning agents. The physiological α-MSH is composed of 13 amino acids. Its small size and linear structure allowed for extensive structure-function studies, which revealed that most of the melanotropic activity of the hormone resides in the His6-Phe7-Arg8-Trp9 core sequence [112,113,114]. The best known α-MSH analog is the tridecapeptide NDP-MSH or afamelanotide.


QUOTE
Subsequently, systemic administration of NDP-MSH, which led to increased pigmentation, was reported to prevent sunburn and reduce UV-induced DNA damage, particularly in individuals with light skin color who burn readily upon sun exposure [119]. These reports provided compelling evidence for the efficacy of α-MSH analogs in photoprotection, and ability of melanocytes to respond to exogenous treatment with NDP-MSH, despite the synthesis of endogenous melanocortins by keratinocytes and melanocytes.

To target specifically the melanocytes with α-MSH peptide analogs, it is ideal to develop highly MC1R selective peptides to reduce off-target effects. With this in mind, we are developing small peptide α-MSH analogs that are MC1R-selective, and mimic α-MSH in enhancing DNA repair, and stimulating pigmentation. Our goal is to develop these peptides for topical application, which is more practical and provides greater target specificity than systemic administration. For topical application, peptides need to be lipophilic, in order to enhance their permeation through the stratum corneum and the epidermal layers of human skin. We have designed n-capped tetrapeptide α-MSH analogs, with 4-phenylbutyryl-His-D-Phe-Arg-Trp-NH2 as the lead peptide, and tested them on primary human melanocyte cultures [120]. This lead peptide proved to be considerably more potent than α-MSH in stimulating the activity of tyrosinase, hence melanogenesis, and in enhancing repair of UV-induced photoproducts, and reducing UV-induced apoptosis of human melanocytes [120]. Moreover, this peptide had a more prolonged residual effect than α-MSH on stimulation of tyrosinase activity [120].

Our data showed that our tetra- and tripeptide analogs require expression of functional MC1R, and have no effects on cultured human melanocytes that express two loss-of-function MC1R variants, a genotype strongly associated with red hair, fair skin and poor tanning ability [49,120,123]. This suggests that our peptides will not benefit individuals expressing loss-of-function MC1R, who have increased UV sensitivity and high risk for skin cancer and melanoma.

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investek
Posted on: Aug 30 2018, 12:37 AM


Group: Member
Posts: 259

But now Darren has sixty thousand reasons to push forward with a NASDAQ listing.
I suspect this will happen shortly, highly likely within FY19... also seems they are pushing hard for an acquisition

From page 18 of the Prelim Final Report
QUOTE
Long-Term Incentive – Business Generation Incentive
During 2017/18, business generation incentives were introduced to the remuneration package for the Chief Financial Officer. These longer- term incentives must be achieved before 30 June 2019 and are linked to the Company achieving exceptional business outcomes that contribute to creating corporate value and to act as a key retention tool. The business generation incentives are $60,000 for each incentive and are linked to successful listing of the Company on an overseas exchange and expansion of the Company through acquisition with demonstrated positive cash flows of the acquired entity post-acquisition.

https://yourir.info/resources/fee77b1d1a878...cial_Report.pdf
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investek
Posted on: Aug 29 2018, 03:15 PM


Group: Member
Posts: 259

Before you sign the papers/mail the cheque take a look at the link below, might save you ~$175k

https://www.sothebysrealty.com/eng/sales/de...sland-in-manihi
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investek
Posted on: Aug 20 2018, 03:31 PM


Group: Member
Posts: 259

You’re welcome Farleap11.
Unfortunately I couldn’t make it to the conference in Sydney, I’d also be interested to hear what Dr Lim had to say if anyone managed to attend or get a copy of the presentation.

Hi ajshare, Re: TFWA Asia conference, I also noticed this on the Clinuvel website some time back however I’m not convinced that they actually exhibited or presented. They may have attended the conference (as I believe they have in the past) however I couldn’t find any evidence on the TFWA Asia website of Clinuvel or Vallaurix being listed as a participating company.

I agree that we could have an exciting couple of weeks ahead, looking forward to some solid announcements.

GLTA!

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investek
Posted on: Aug 19 2018, 09:14 PM


Group: Member
Posts: 259

I still can’t find any evidence of the Skincare product launch however it looks like Clinuvel will be presenting at the conference below...

18TH ANNUAL BIOTECH IN EUROPE FORUM
, 4TH-5TH OCTOBER 2018 @ CONGRESS CENTER BASEL, SWITZERLAND


PRESENTERS AT THE #Sachs_BEF FORUM

QUOTE
The 18th Annual Biotech in Europe Forum is recognised as the leading international stage for those interested in investing and partnering in the biotech and life science industry. This highly transactional event draws together an exciting cross-section of early-stage/pre-IPO, late-stage and public companies with leading investors, analysts, money managers and pharma licensing executives. Supported and designed by leading figures within Europe’s pharmaceutical and biotech industry, this event will once again be covered by our regular media partners. We expect over 650 delegates and over 100 presenting companies and 20+ pitches by seed companies.

Is Clinuvel looking for a distribution partner to help with later stage drug roll-out in the US or worldwide?

http://www.sachsforum.com/18bef-presenters.html

QUOTE
CLINUVEL AG
The CLINUVEL story starts in 1987 when university researchers launched an idea of synthesising human hormones to protect the skin. During this period, little was known about the properties of alpha-MSH (melanocyte stimulating hormone), although the scientists had discovered the biomimicry which these hormones could evoke (providing a golden glow without sun exposure). A basis was laid, but the majority of the research & development work was ahead to actually build a relevant product and successful company around this beginning scientific idea.

The CLINUVEL team in Australia obtained the rights to the technologies and established a company around alpha-MSH, its derivatives and knowledge. With an unabating focus and unusual willpower the CLINUVEL teams charged ahead and developed innovative technology which would release the hormonal analogue in picograms (10¯¹² grams) per day in a controlled fashion. With the world’s first dissolvable implant releasing a novel hormone to mimic the effects of the sun on human skin but without incurring the photo damage, our teams worked for two decades to test the technology - SCENESSE® - in more than 1,400 patients worldwide through 4,500 doses. Innovation came with rigid testing.

In 2014, the European Medicines Agency and the European Commission approved SCENESSE® as the world’s first photo protective drug for market authorisation to be distributed to European patients treated by specialist hospitals, dermatologists and other specialists. What had once been thought of as science fiction had become reality in October 2014, when SCENESSE® became the first systemic drug providing protection to the entire skin surface without exposure to light and UV. Currently, the Food and Drug Administration is reviewing the innovative pharmaceutical product for release in the United States. At CLINUVEL we focussed and specialised for two decades on extreme disorders which were provoked by environmental conditions, such as erythropoietic proto- and congenital porphyria [EPP, CEP], Solar Urticaria and other light-induced diseases. Worldwide the erythropoietic protoporphyria patients are forced to live an indoors existence deprived of any light source.

http://www.clinuvel.com/


So that’s two conferences between now and year end (the other being the 2018 Vitiligo International Symposium, Detroit, MI November 9-10) but nothing in Asia? Seems they are waiting for something (priority review? FDA approval?) before unveiling the skin care products... I feel less and less confident that we’ll see a cosmetic before the AGM / end of the year.
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investek
Posted on: Aug 16 2018, 09:59 PM


Group: Member
Posts: 259

Great find!

The article below outlines the pathways from senescence to melanoma and includes MITF sumoylation.
I find it interesting that this was published in August 2017, how much earlier did Wolgen know of or suspect these pathways / mechanisms of action existed? I suppose the trademark was only filed this year so perhaps the sumoylation connection was new to Wolgen?

QUOTE
Pathways from senescence to melanoma: Focus on MITF sumoylation
Abstract
Cutaneous melanoma is a deadly skin cancer that originates from melanocytes. The development of cutaneous melanoma involves a complex interaction between environmental factors, mainly ultraviolet radiation from sunlight, and genetic alterations. Melanoma can also occur from a pre-existing nevus, a benign lesion formed from melanocytes harboring oncogenic mutations that trigger proliferative arrest and senescence entry. Senescence is a potent barrier against tumor progression. As such, the acquisition of mutations that suppress senescence and promote cell division is mandatory for cancer development. This topic appears central to melanoma development because, in humans, several somatic and germline mutations are related to the control of cellular senescence and proliferative activity. Consequently, primary melanoma can be viewed as a paradigm of senescence evasion. In support of this notion, a sumoylation-defective germline mutation in microphthalmia-associated transcription factor (MITF), a master regulator of melanocyte homeostasis, is associated with the development of melanoma. Interestingly, this MITF variant has also been recently reported to negatively impact the program of senescence. This article reviews the genetic alterations that have been shown to be involved in melanoma and that alter the process of senescence to favor melanoma development. Then, the transcription factor MITF and its sumoylation-defective mutant are described. How sumoylation misregulation can change MITF activity and impact the process of senescence is discussed. Finally, the contribution of such information to the development of anti-malignant melanoma strategies is evaluated.

https://www.researchgate.net/publication/31...ITF_sumoylation

Senescence - SCENESSE
https://www.trademarkia.com/scenesse-79088813.html

Sumoylation - TSUMOYL
https://www.trademarkia.com/ctm/tsumoyl-017877352.htm

At least Tsumoyl makes a bit more sense now and I don’t just think of Sump Oil when I read it!
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investek
Posted on: Aug 15 2018, 12:43 AM


Group: Member
Posts: 259

Below is an excerpt from a post I made on 27th Oct 2017, some of the info may be useful. I’ve also added an excerpt and link to the Singapore Gov requirements for cosmetics.

QUOTE
I think that a Vallaurix cream, (Chivere?) could be marketed as a moisturiser and not be subjected to the drug approval process. My (extremely limited) knowledge in this area suspects this could possible and would come with the added advantage of not being required to include a product ingredient listing. This would seem to fit with a Wolgen 'trade secret' style of operation (and is just the kind of genius I'd expect from him!)

The more I think about it, the more I like this ‘Coca Cola style’ secret recipe strategy...

QUOTE
The text below is from a site that talks about the lack of regulation of cosmetics, http://fortune.com/2017/06/27/fda-cosmetics-regulations/
I'm yet to find much more 'official info' on the topic, perhaps Punkassderm can shed some more light?

“If you wanted to create a batch of homemade moisturizers and sell them online, you could go ahead and start—no paperwork, pre-market approval process, or registration required, says Dr. Steve Xu, a resident physician in the department of dermatology at Northwestern University Feinberg School of Medicine.

That’s because cosmetics, which fall under the purview of the Food and Drug Administration, are very lightly regulated. While the agency has some labelling requirements, companies can easily avoid listing a product’s ingredients by claiming doing so what give away trade secrets. What’s more, manufacturers don’t have to report health complaints to the FDA.

To identify potentially dangerous products, the agency relies on direct reports of adverse events from consumers. Understandably, these are pretty sparse (In 2014, the FDA opened an investigation into Wen Hair Care products after receiving 127 complaints that it caused hair loss. Unbeknownst to the agency, the company had already received more 21,000 complaints from consumers.)”


QUOTE
In Singapore, the Health Sciences Authority (HSA) oversees the safety issues linked to cosmetic products.
These include:
- Items we find in our bathroom cabinets such as toothpastes, bath products, shower gels, shampoos, conditioners and shaving creams;
- Products on our dressers such as make-up items, skin whitening, anti-wrinkle creams and perfumes/fragrances.
- Sunbathing lotions and hair dressing products (e.g. tints and lotions for perms and straightening).

How are cosmetic products regulated in Singapore?
As they are considered to be generally of lower risk than other health products, cosmetic products do not require HSA's approval before they are placed on the market. They are also not assessed or approved by HSA for their effectiveness before being sold. Companies who manufacture, import and sell cosmetic products are directly responsible for the safety of their products.

http://www.hsa.gov.sg/content/hsa/en/Healt.../Cosmetics.html
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investek
Posted on: Aug 11 2018, 10:51 AM


Group: Member
Posts: 259

Interesting development...

Seems Clinuvel has been following this for some time, from their website.
QUOTE
XP - Experimental treatments
Recently novel enzyme and gene therapies have been developed based on the etiology of XP. T4N5, a bacteriophage T4 endonuclease 5 has been utilized for topical therapy in a liposomal lotion. It is able to diffuse into the nucleus without a nuclear localization sequence and enables NER to recognize and cleave CPDs using light energy. This lotion holds significant promise for those with XP, receiving a Fast Track designation from the FDA.

https://www.clinuvel.com/photomedicine/clin...-pigmentosum-xp

The company behind T4N5 was acquired by Estée Lauder, who now apparently control the market for supplying DNA repair enzymes.
QUOTE
Yarosh’s efforts to raise the money he needed were ultimately in vain. “But in the process, AGI got an offer from Estée Lauder to sell, and that's the business decision that we made. So the company I founded is now a subsidiary of Estée Lauder, and it continues to supply these repair enzymes and liposomes." Estée Lauder controls the market, and enough of its customers are willing to pay for DNA repair enzymes that it can charge high prices for them

https://www.wired.com/story/dna-repairing-s...egit-or-nah/amp

It also appears that Dimericine Liposome Lotion was never approved by the FDA.
https://www.drugs.com/history/dimericine.html

So how do Estée Lauder get away with selling products/ingredients that appear to have a biological effect as a cosmetic??!!

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investek
Posted on: Jul 29 2018, 05:01 PM


Group: Member
Posts: 259

QUOTE
In April and May, CLINUVEL will publish three successive SCIENTIFIC COMMUNIQUÉS to review the current understanding and progress in proopiomelanocortin (POMC) science and photomedicine.

9th April 2018
http://www.clinuvel.com/images/pdf/201804S...COMMUNIQUÉ1.pdf

QUOTE
In SCIENTIFIC COMMUNIQUÉ III –scheduled for June – we will review the effects of afamelanotide, CLINUVEL’s lead drug, on the human genome, based on existing literature.

May 2018
http://www.clinuvel.com/images/2018/201805...QUÉ_II_FULL.pdf

Well they’ve missed June (2018), not many days left if SCIENTIFIC COMMUNIQUÉ III is to be published in July...

QUOTE
CLINUVEL will attract a wider audience in 2018, not the least by diversifying its product offerings to new markets. The knowledge gained as a specialty pharmaceutical company, and the confidence gained among the top academic experts worldwide, will need to be translated into a continuum benefiting a wider market. CLINUVEL will launch its premiere non-pharmaceutical product lines under private label. These dermatological products will be complementary to SCENESSE®. Fitting our 2018 strategy, CLINUVEL will exhibit its first conference display in Asia and Europe, our main targeted markets. This will be discussed by our Managing Director in more detail over coming months.

11th Jan 2018
https://yourir.info/resources/fee77b1d1a878....pdf?download=1

1) Will we see an actual launch of these dermatological products this year? (Will it actually be possible to buy something from CUV or Vallaurix as a consumer??!)

2) Will Clinuvel exhibit at conferences in Asia and Europe within 2018? (Aside from a vitiligo conference we haven’t found much evidence)

3) Will we (at a minimum) be able to see and touch non-pharmaceutical products at this year’s AGM?
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investek
Posted on: Jul 24 2018, 11:40 PM


Group: Member
Posts: 259

Nice find frank2you, thanks!

I have a feeling this could actually be good news for Clinuvel however I need Uho or others more knowledgeable in Biochem to confirm my hypothesis.

Basically, I think that SCENESSE activates a very similar pathway to that which the authors of the study claim as being therapeutic.

University of Massachusetts Medical School (referenced article) - Excerpt
QUOTE
These three other labs first found cells in vitiligo skin from mice or humans that looked a lot like the memory cells that protect the skin from a second exposure to a viral infection, suggesting that the body “thinks” it is fighting a viral infection when it “misfires” at the patient’s normal cells, killing the pigment-producing cells in the skin called melanocytes and causing vitiligo. These cells are called “resident memory T cells.”

Similar to the other labs, we also found the virus-like memory cells, and we were able to also determine that these cells specifically targeted the melanocytes. We hypothesized that if we could remove these memory cells from the skin using a new treatment, then treatments to repigment the skin would be long-lasting and possibly permanent.

Our team figured out that the vitiligo-causing memory cells require a special protein called “IL-15” to survive. We injected the vitiligo mice with an antibody that blocks the IL-15 protein from interacting with the memory cells.

After just a few weeks we discovered that the treatment wiped out the memory cells from the mouse skin, allowing the brown pigment to return in a spotty pattern, just as we see in patients who respond to therapy.


Hypothesis: SCENESSE will induce death in mast cells and without mast cells memory T cells will die. I also suspect SCENESSE may downregulate IL-15.

A few references below... I appreciate any builds/corrections.

1) Interleukins are regulated, increase/decrease by Msh/Scenesse, paritcularly much research with implictions on inflammation/homeostasis to IL-1, IL-6, IL-8, IL10
Google Groups - credit to Uhohinc

2) α-Melanocyte-stimulating hormone induces cell death in mast cells: involvement of NF-κB
https://www.sciencedirect.com/science/artic...01457930300797X

3) Human mast cells drive memory CD4(+) T cells toward an inflammatory IL-22(+) phenotype
https://www.researchgate.net/publication/23...2_phenotype/amp
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investek
Posted on: Jul 22 2018, 06:33 PM


Group: Member
Posts: 259

Progress of the Patent Application US20170304406 NEW INDICATION FOR ALPHA-MSH ANALOGUES - treatment of neurodegenerative disorders, does not look good at all!
https://patentscope.wipo.int/search/en/deta...mp;queryString=

Final Rejection
19/07/2018
https://patentscope.wipo.int/search/docserv...22600XP1%20.pdf

I’m no patent expert however I doubt this claim is going anywhere.

Also seems Clinuvel (or the Patent attorney more specifically) has managed to piss off the examiner! See excerpts below.

Not sure if this is amateur hour (yet again) or just bad luck?! I struggle to see how Big Pharma manage to gain >100 patents on one drug and Clinuvel has had to fight so hard for 6 or so (which will provide less protection than the market exclusivity periods it seems...)

This Shield of Patents Protects the World’s Best-Selling Drug
Over Humira’s lifetime, AbbVie has secured more than 100 patents to prevent anyone from attempting to copy the biologic, with $16 billion in annual sales.
https://www.bloomberg.com/news/articles/201...st-selling-drug

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investek
Posted on: Jul 22 2018, 04:32 PM


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Posts: 259

I’m guessing that Dr Lim’s presentation will cover some material from the following journal article.

Current challenges in photoprotection
Henry W. Lim, MDcorrespondenceEmail the author MD Henry W. Lim, Maria-Ivonne Arellano-Mendoza, MD, Fernando Stengel, MD
Published Online: December 27, 2016
https://www.jaad.org/article/S0190-9622(16)30882-9/fulltext

Several extracts below...emphasis mine

QUOTE
Electromagnetic radiation in the ultraviolet, visible, and infrared ranges all produce biologic effects. Ultraviolet filters are the most well-studied photoprotective measure for the adverse effects of ultraviolet radiation. Because of the reported endocrinologic effects of oxybenzone in animal studies, its effects on coral reefs, and its photocontact allergy potential, its use has been minimized in many countries worldwide. New developments in topical antioxidants and oral and subcutaneous agents (eg, Polypodium leucotomos extract, afamelanotide, nicotinamide) with photoprotective and antiphotocarcinogenic properties could potentially provide addition modalities for protection against the effects of visible light and infrared radiation
.

QUOTE
Oral & Subcutaneous photoprotection
There is growing interest in the potential for oral and subcutaneous agents to provide additional protection against exposure to UVR and to further reduce damage that ordinarily would lead to photoaging and skin cancer. These agents are different from sunscreens in their mechanism of action, in the different end points important in measuring efficacy, and in the benefits of their use. Several orally and subcutaneously administered agents have been shown to have the potential to reduce the severity of a sunburn, decrease photosensitivity, and prevent photodamage; however, larger studies need to be done to confirm efficacy and safety. Several of these agents are in late stages of clinical development.


QUOTE
Afamelanotide
Afamelanotide is a structural analog of α-melanocyte-stimulating hormone that was shown to be beneficial as an adjunctive photoprotective agent in patients with EPP and solar urticaria. As an agonist of the melanocortin-1 receptor, afamelanotide promotes synthesis of melanin (eumelanin), which is photoprotective, and acts as an antioxidant. In clinical trials, it was administered as a controlled-release, subcutaneous implant that released the drug over approximately 2 weeks; melanin concentration was increased after 2 days, with the effect lasting up to 2 months.63 After undergoing phase II and III clinical trials in Europe and the United States,64-66 afamelanotide, administered as 16 mg subcutaneously every 60 days, received regulatory approval in Europe for prevention of phototoxicity in adult patients with EPP. In 2 randomized, double-blind, placebo-controlled phase III studies, in 74 European patients with EPP and in 94 US patients with EPP who each received 5 or 3 subcutaneous implants, respectively, every 60 days, those who received afamelanotide experienced significant improvements in duration of pain-free time under direct sun exposure compared with placebo.66 Quality of life was also improved in both treatment groups, and adverse effects were mostly mild (consisting of headache, nausea, nasopharyngitis, and back pain). In the longer European study, phototoxic reactions were significantly less severe, with shorter recovery time in patients on afamelanotide. Afamelanotide has also been investigated as treatment of solar urticaria in a small study of 5 patients; it resulted in increased synthesis of melanin and an increase in tolerance to artificial light exposure.67 It should be noted that a phase III trial with afamelanotide in polymorphous light eruption was started in 2007 and completed in 2010 (NCT00472901), and a phase II trial against actinic keratosis in organ transplant recipients was started in 2009 with unreported study conclusion (NCT00829192). The results of these 2 trials have not been published to date.

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investek
Posted on: Jul 22 2018, 01:42 AM


Group: Member
Posts: 259

Can anyone make it to this event? I’m interested to know what Dr Henry Lim has to say...

WORLD CONGRESS ON CANCERS OF THE SKIN®
15 - 18 August 2018
International Convention Centre Sydney, Australia


Preliminary Program
Thursday 16 August 2018
11:00-12:00

Controversies in Photo Protection
Henry Lim
(30 minutes)

https://wccs2018.com/cms/wp-content/uploads...8-Program-2.pdf

On a related subject Clinuvel seems to be positioning to ‘own’ the photo protection space, note the following:
Photoprotection URL redirects to Clinuvel.com
http://photoprotection.com

YouTube Channel - The Photoprotection Channel set up by Clinuvel
https://m.youtube.com/channel/UC-CsMzFtkr20ps4z-xnvjlg
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investek
Posted on: Jul 20 2018, 09:30 PM


Group: Member
Posts: 259

Ok so I think I’ve finally figured out the recent share price drop...

There were never any skin care products! It was Women’s Running Shoes they’ve been waiting to announce as the new secret products!
(Perhaps they will be sold duty free through B&S!)

http://hakodate-majima.site/clinuvel/our-p...ent/lachlan-hay

http://hakodate-majima.site/
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investek
Posted on: Jul 17 2018, 11:40 PM


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Posts: 259

Interesting that the page on Intellectual Property has been pulled from the Clinuvel website...
http://www.clinuvel.com/science-of-skin-la...ectual-property

Now not even the cached page is appearing.. it was working over the weekend, see screenshot below.
http://webcache.googleusercontent.com/sear...;cd=4&hl=en

From a quick search I could only confirm 5 of the patents as Granted, the others were Patent Applications (skin cancers) / Abandoned Applications (photosensitivity PDT) / ? (DNA protection).

Why publish the page then pull it? Will it be back?
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investek
Posted on: Jul 7 2018, 12:38 AM


Group: Member
Posts: 259

I agree it’s bullish that Biljdorp has purchased the 1.3mil shares from Lagoda, however the timing/terms are interesting,.. especially given the Preliminary Annual Results are normally released by the end of August. In conflict with the (now out-dated?) Clinuvel Share Trading Policy?

https://www.asx.com.au/asxpdf/20101230/pdf/...yqrl3h90syp.pdf

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investek
Posted on: Jun 29 2018, 08:11 PM


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Posts: 259

I'm assuming 'afamelanotide doses' includes injections of afamelanotide solution within the early phase studies and 'SCENESSE implants' are the slow release dissolving implants that were developed/used at a later stage...
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investek
Posted on: Jun 23 2018, 05:07 PM


Group: Member
Posts: 259

I was thinking something similar regarding World Vitiligo Day on Monday.

Perhaps the trading halt/market sensitive announcement with encompass not only a confirmation of the NDA submission for SCENESSE in EPP but also details of an agreed upcoming Phase 3 trial for a second indication Vitiligo?

See below extract from a prior (Aug 2016) CUV release that mentions the next steps re:Vitiligo.

QUOTE
FDA REQUIREMENT
CLINUVEL has completed one US Phase II clinical trial of SCENESSE® in vitiligo patients (CUV102), with a second study (CUV103) underway in Singapore. In both studies the drug has been used in combination with NB-UVB light to evaluate its safety profile and ability to repigment skin in vitiligo patients.

The results of CUV102 and preliminary results in CUV103 show that SCENESSE® in combination with NB-UVB light administered twice or thrice weekly had a good safety profile, and the optimal effectiveness of the combination was identified in patients of darker skin complexion (Fitzpatrick skin types IV, V and VI).1

The FDA communicated to CLINUVEL that – prior to pursuing later stage clinical trials and seeking marketing authorisation for SCENESSE® in vitiligo in the US – the company would need to demonstrate the safety of the drug in combination with NB-UVB light, simulating the proposed human dose regimen in a pre-clinical model.

Now that the requirement has been completed, CLINUVEL will request a guidance meeting (Type C) with the FDA to discuss the next clinical trial in vitiligo patients in North America.


http://clinuvel.com/investors/news/item/49...ination-therapy
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investek
Posted on: Jun 23 2018, 03:28 PM


Group: Member
Posts: 259

CUV seems to have an increased focus on Vitiligo

The Instagram account definitely has a large amount of Vitiligo content and Clinuvel is a Silver sponsor of the 2018 Vitiligo International Symposium, http://vis2018.org/ (credit to Walltrader2014 from the German forum for this find).


World Vitiligo Day conference also on this weekend, no mention of CUV in the program however some familiar names presenting Dr Grimes, Lee Thomas, etc
https://www.umassmed.edu/globalassets/vitil...d18-program.pdf

Also appears there is a live-stream available for some of the program, perhaps CUV will get a mention?
https://go.umassmed.edu/wvd18-livestream
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investek
Posted on: Jun 21 2018, 11:37 AM


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Posts: 259

I posted this in Feb, however seems worthy of a repost for those who missed it first time round...
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investek
Posted on: Jun 2 2018, 03:43 PM


Group: Member
Posts: 259

Interesting...I have also been tracking the Google trends data on several search terms for a while, yet my results show a totally different curve for 'Clinuvel', see below.

Could it be that we have entered slightly different search parameters, I have tried to go for the broadest possible and not constrained it to a data type, e.g. Company, or is it adding the comparators that changes the relative results? (i.e. The other search terms act as a more stable baseline/reference point?)

Legend:
Yellow = Clinuvel
Blue = Scenesse
Red = Afamelanotide
Green = Melanocyte-stimulating hormone
Purple = Admedus (another healthcare company I'm tracking)

http://bit.ly/2J7nr5T
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investek
Posted on: May 17 2018, 02:27 PM


Group: Member
Posts: 259

Nice work waz, thanks!

Johnny try the link below:
https://www.asx.com.au/asxpdf/20180517/pdf/...399b2l4cgcv.pdf

Also this page should help you find any other previous ASX announcement.
https://www.asx.com.au/asx/statistics/announcements.do
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investek
Posted on: Apr 22 2018, 12:48 PM


Group: Member
Posts: 259

Hi Fortescue Bullrout,

Sharelooker proposed a connection on Feb 5, 2018, see post I've replied to / text below.
QUOTE
Maybe the "skincare solutions" will be distributed trough the B&S (https://www.bs-gg.com/nl) channel?! Bleidurps former company!
Any thoughts on this?


I'm yet to find any concrete link to "Artemis Skincare" however it seems plausible (why change a great logo to a complicated one with Artemis/Diana unless new products are linked to this Goddess?) Thinking about the addition of Blijdorp to the board, distribution through B&S International would enable the 'Skincare Solutions' products to be widely available through many duty free outlets (potentially one of the 2 distribution channels CUV mentioned?)
https://www.bs-group-sa.com

I hope this helps.

Cheers,
Investek
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investek
Posted on: Apr 22 2018, 09:11 AM


Group: Member
Posts: 259

Artemis (Diana) came from finding the preview of the new logo and mention of companies with Artemis in the name is part of investigating possible links to the future direction of CUV.

On Oct 18, 2017 PunkassDerm commented.
QUOTE
This is Artemis (Diana). Is there an Artemis group or pharma?
https://imythology.wikispaces.com/Diana


Combined with CUV's statement below I think it's plausible that a pending acquisition/product licensing drove the logo change.

QUOTE
The Company will further expand through the licensing of a product and/or an acquisition. The objective is to increase the product offerings.


Some of the 'Artemis' Pharma/Skincare companies previously mentioned are listed below, Artemis of Switzerland / Artemis Skincare seems the most logical fit with CUV to me.

1. Artemis Therapeutics, Inc. (ATMS)
http://www.artemis-therapeutics.com

2. ARTEMIS Pharmaceuticals (owned by Exelixis Inc.)
https://www.bioportfolio.com/corporate/comp...aceuticals.html
https://www.exelixis.com/

3. Artemis of Switzerland
http://www.artemis-skincare.com/

___________________________

Yes Macgyver, fully aware that Artemis Skincare has been around since 2015, I previously posted links to articles related to Artemis Skincare from 2011!
https://translate.googleusercontent.com/tra...zvU6y2ZVQX563AA
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investek
Posted on: Apr 21 2018, 06:53 PM


Group: Member
Posts: 259

Interesting to note that http://www.artemis-skincare.com is now live!
And only 1 month before the announcement of a new CUV skincare product range...coincidence?
(Previously only an archived version was available, see related post)

Is this a potential (all share) acquisition? or super complex JV arrangement (probably more likely...) Could explain why the share price has been allowed to run-free over the last ~6 months.

I've re-posted my theory on potential future group structure / product offerings below. Chivere may now need to be replaced with Tsumolye (Sump oil! biggrin.gif Thanks to whoever posted that, makes me laugh every time!)
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investek
Posted on: Apr 15 2018, 06:24 PM


Group: Member
Posts: 259

Cheers.

I'm no patent expert however to my knowledge this is how the PCT (Patent Cooperation Treaty) process works.
QUOTE
The PCT makes it possible to seek patent protection for an invention simultaneously in a large number of countries by filing a single "international" patent application instead of filing several separate national or regional applications. The granting of patents remains under the control of the national or regional patent offices in what is called the "national phase".

http://www.wipo.int/pct/en/faqs/faqs.html

So I believe CUV is now entering the US national phase (no idea how long that usually takes, appreciate any further info).
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investek
Posted on: Apr 15 2018, 04:29 PM


Group: Member
Posts: 259

Patent Application 20180094039 published 5 April 2018
PHARMACEUTICAL COMPOUND
The present invention relates to compounds comprising a quaternary ammonium group, their use in skin diseases, and their preparation.
Applicant: Vallaurix
https://patents.justia.com/patent/20180094039

Patent Application 20180086789 published 29 March 2018
PHARMACEUTICAL COMPOUND
The present invention relates to an alpha-MSH analogue compound, the use in skin diseases, and the preparation.
Applicant: Vallaurix
https://patents.justia.com/patent/20180086789


Could these be the topical adjuvant maintenance therapy for Vitiligo or the paediatric formulation for SCENESSE Enfance?
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investek
Posted on: Apr 15 2018, 01:40 PM


Group: Member
Posts: 259

http://bit.ly/RogerCone
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investek
Posted on: Apr 12 2018, 01:57 AM


Group: Member
Posts: 259

http://lucasmeyercosmetics.com/mailing/pdf...il-brochure.pdf
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investek
Posted on: Apr 12 2018, 01:31 AM


Group: Member
Posts: 259

I don't recall having seen these products before. If they work as claimed surely they infringe CUV's IP!

Tanning

MelinOilTM
(INCI: Isopropyl Palmitate, Lecithin,
Aqua, Acetyl Hexapeptide-1) MelinOILTM
is an oil-soluble version of a patented α-MSH biomimetic peptide. The smart lipophilisation technology used in MelinOILTM leads to a transparent micro dispersion of the peptide in an oil allowing its formulation into clear oil-based products. MelinOILTM binds MC1-R both on melanocytes and keratinocytes to stimulate the natural skin defence system against sun and also stimulate melanin production in the hair bulb to reverse the signs of greying (hair and beards). MelinOILTM acts effectively and simultaneously on melanogenesis to improve natural cell UV protection by melanin, on DNA repair to limit photo ageing and on the in ammatory cascade to soothe sun-ravaged skin.
Recommended inclusion level 0.5 - 5%

Melitane®
(INCI: Glycerin (and) Water (and) Dextran (and) Acetyl Hexapeptide-1) is a peptide agonist of the α-MSH (α-melanocyte stimulating hormone). Because of its af nity with the receptor MC1-R, Melitane® can be used as a natural photoprotector and as an in ammation modulator. Melitane® stimulates pigmentation and Melanin (natural protection factor) under UV-inducing conditions. Melitane® complements the skin’s own level of natural Melanin and strengthens the skin’s defence. In addition, Melitane® makes the skin less sensitive to UV-induced erythema.
Recommended use level: Tanning effect: 0.5 - 5%; Soothing effect: 1 - 5%; Protective effect: 1 - 2.5%; DNA protection and repair: 0.5%

https://infinity-ingredients.co.uk/assets/u...ing-Range-6.pdf
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investek
Posted on: Apr 11 2018, 01:02 AM


Group: Member
Posts: 259

Re: CUV patent for Vitiligo, credit to ajshare who posted this last year, patent granted!
http://www.sharescene.com/index.php?act=at...st&id=48600

Also link/screenshot of AU Vitiligo patent
http://pericles.ipaustralia.gov.au/ols/aus...y!199765566
http://pericles.ipaustralia.gov.au/ols/aus...y%7DqksEjzw%7Fv


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investek
Posted on: Apr 5 2018, 01:32 PM


Group: Member
Posts: 259

Perhaps the new Orphan indication is Bullous Disease?

The AGM presentation, see slide below, stated that IP had already been filed, see (WO2015063102) ALPHA-MSH ANALOGUES FOR USE IN BULLOUS DISEASE, https://patentscope.wipo.int/search/en/deta...=PCTDescription

I believe Bullous Disease would be categorised separately from familial chronic pemphigus (Hailey–Hailey disease, for which CUV already has US orphan designation)
http://clinuvel.com/2014-announcements/ite...-hailey-disease

Management of familial benign chronic pemphigus
"Furthermore, unlike in bullous diseases such as pemphigus vulgaris, antidesmosomal autoantibodies might not be detected."
https://www.ncbi.nlm.nih.gov/pmc/articles/P...!po=6.42857



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investek
Posted on: Apr 5 2018, 09:14 AM


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Posts: 259

"they can charge pharma prices for non-pharma products" or they can just give it away...

"The global identity reflects both the Group’s values and evolution as it focusses its research and development on complimentary product lines with a theme on “the interaction of human skin with its environments’, aiming to deliver innovative pharmaceutical solutions for complex problems."
https://www.asx.com.au/asxpdf/20180220/pdf/...qlkjtl7dw5f.pdf

I am tempering my expectations.
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investek
Posted on: Mar 28 2018, 02:51 PM


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Posts: 259

The 2016 AGM presentation has an overview, see below.

"A competitive breakdown of research groups and companies active in melanocortins is discussed" slide 22
https://yourir.info/resources/fee77b1d1a878....pdf?download=1


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investek
Posted on: Mar 24 2018, 05:55 PM


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Non pretium sensitivo? (Locari)

Sabbati forsitan proximus?
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investek
Posted on: Mar 24 2018, 09:31 AM


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Posts: 259

Well this isn't great news, seems the update the Chair gave at the recent AWMSG meeting was a negative outcome for Scenesse being reimbursed in Wales.
http://www.awmsg.org/awmsgonline/app/appraisalinfo/634
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investek
Posted on: Mar 24 2018, 09:28 AM


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Posts: 259

Thanks Johnnytech.

Re: CUV - I don't believe a NASDAQ listing will affect CUV:ASX (assume they will just be cross listed)

Re: CLVLY - conversation from ADR to Share, I'm not qualified to answer (perhaps some other ADR holders can clarify) I suggest you get formal (tax?) advice.
I did however find a couple of articles below that may help you.

Logitech Press Release
In order to increase our trading liquidity on NASDAQ we have announced a mandatory exchange of ADRs for Logitech shares.
After the exchange our shares will continue to trade on NASDAQ under the ticker symbol 'LOGI'.
If you hold your ADRs in a broker account no action on your part is required. This exchange will happen automatically on October 23, 2006. Your broker will charge you a fee of $0.025 per ADR for the automatic exchange.
http://s21.q4cdn.com/947125427/files/doc_n...ge_FINAL_JG.pdf

Foreign Stock Forum
Naval March 11, 2015 at 12:54
If I choose the option of converting the ADR to ordinary shares, is that considered a sale for tax purposes with associated Capital Gains/Loss?

David March 12, 2015 at 9:59 pm
Nope. You will not be charged any taxes for converting ADRs to ordinary shares including any capital gain/loss associated with the transaction. Thx.
http://topforeignstocks.com/2014/08/08/wha...nyse-or-nasdaq/
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investek
Posted on: Mar 24 2018, 12:57 AM


Group: Member
Posts: 259

After reviewing the NASDAQ Initial Listing Guide, (thanks Frogster) specifically the requirements for the various tiers: The Nasdaq Global Select Market®, The Nasdaq Global Market® and The Nasdaq Capital Market®. I have a theory as to why a listing has not yet occured and when/how it may happen.
https://listingcenter.nasdaq.com/assets/initialguide.pdf

Until the end of last financial year CUV failed to meet the criteria for all but one of the NASDAQ tiers, Capital Market.

The maiden profit last financial year and an assumed modest profit this financial year would mean that after July 2018 CUV should qualify for The Nasdaq Global Market or, provided there is a decent uptick in sales, potentially even The Nasdaq Global Select Market.

My theory is that a NASDAQ listing has been intentionally held off until these requirements are met so that CUV can list in a more prestigious tier and make the most of the initial interest/new buyers.

It is debatable whether cross listings add value however I believe in the case of CUV being so tightly held a NASDAQ listing would create value. Furthermore I believe it would help increase liquidity however the McKinsey article below casts doubt on both of these points.
https://www.mckinsey.com/business-functions...nt-create-value

Finally I thought it was worth including a link to this interview with Jordan Saxe, Senior Managing Director and head of healthcare listings at Nasdaq, where he outlines his predictions for Biotech IPOs in 2018.
http://business.nasdaq.com/marketinsite/20...redictions.html

Seems it could be a busy year for biotech's (and CUV?) on the NASDAQ!
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investek
Posted on: Mar 23 2018, 02:51 PM


Group: Member
Posts: 259

QUOTE
The Company will further expand through the licensing of a product and/or an acquisition. The objective is to increase the product offerings.


https://yourir.info/resources/fee77b1d1a878....pdf?download=1
Page 37
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investek
Posted on: Mar 9 2018, 09:24 AM


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Posts: 259

March 2018 Quarterly rebalance of the S&P/ASX Indicies
https://www.asx.com.au/asxpdf/20180309/pdf/...9c4xfsrvf0v.pdf

No addition of CUV to ASX300


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investek
Posted on: Mar 5 2018, 11:14 PM


Group: Member
Posts: 259

FT 1000: High-Growth Companies Asia-Pacific
https://ig.ft.com/special-reports/ft-1000/asia-pacific/2018/

CUV #80
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investek
Posted on: Mar 2 2018, 08:20 PM


Group: Member
Posts: 259

I apologized promptly and unreservedly. Again, I'm sorry for any offence caused.
My point was to highlight that we should respect each other (esp. the research and detailed contributions made) and build upon the valuable content. I accept that I could and should have conveyed that more appropriately.

My posts carry no more weight than anyone else's. I don't think I run, nor would I wish to run Sharescene. I post what I able to find as a means of saying thanks to the many members that have provided valuable information over the years.

Not sure my qualifications are relevant, and not trying to 'run' CUV or Wolgen. I was simply putting forward an 'option' whereby retail investors could band together and be heard by CUV management.

Shareholders may not have been aware that they could call a General Meeting.
https://hallandwilcox.com.au/the-right-of-m...rporations-act/
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investek
Posted on: Mar 2 2018, 06:53 PM


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Posts: 259

Apologies seeva, seems I read the text too literally (not the best medium to convey tone).

I agree the performance rights are overly generous and were not tied to the most appropriate milestones.

I know several holders (including myself) voted against the remuneration report several years ago however with the international holders unable to vote and the institutions (given cheap shares in placements) voting with management the company is being run as if it were private!

Don't get me wrong I have no issue with Wolgen getting rewarded for his hard work, I just wish the performance rights were tied to approvals and significant sales increases (so that long term holder's were rewarded commensurately).

I made peace with these decisions years ago, whilst I didn't (and still don't) agree with how Wolgen got his large stake he now has it and I figure our interests are largely aligned. For him to move from Rich to Super Mega Rich he'll surely have to take us on the journey with him.

If you and others are truly sick of the lack of accountability please PM me the number of CUV:ASX shares you own and we can see if we have over 5% collectively (I know we have members representing over ~3% of shares on issue). If we can get another 2% represented we could call an Extraordinary General Meeting. Wolgen and Co. might not action our requests however they would be forced to listen to them!
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investek
Posted on: Mar 2 2018, 02:48 PM


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Posts: 259

Submission!

I'm all for collaboration on the board and helping each other out but please respect the efforts of others before posting lazy questions. Frogster was good enough to provide the document and page number of the performance rights, you could have clicked and scrolled... see below.


Also I sent you a PM some time ago to help clarify one of your questions and you are yet to read it...
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investek
Posted on: Mar 1 2018, 03:24 PM


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Posts: 259

No that isn't new. Status has been "NDA filed" since I first stumbled upon those reports, see post on 24th August 2017.

I see no reason why Clinuvel wouldn't formally announce that the NDA has been submitted once the last module is in (the submission is tied to more performance rights after all!) If the company is in fact coming out of the shadows this is the kind of news I would expect it see communicated via a Press Release, tweet and Facebook post (however it won't surprise me if someone on this forum finds out and posts before the company!)
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investek
Posted on: Mar 1 2018, 11:40 AM


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Posts: 259

Latest OptumRx Brand Pipeline Forecast - Q1 2018

SCENESSE page 12, status unchanged from last quarterly report.
https://www.optum.com/content/dam/optum3/pr...ineForecast.pdf


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investek
Posted on: Feb 24 2018, 01:31 AM


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Posts: 259

I contacted a graphic designer and asked if he could improve the new CUV Group logo.

He sent back the update below!


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investek
Posted on: Feb 21 2018, 09:28 PM


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Posts: 259

.
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investek
Posted on: Feb 21 2018, 07:06 AM


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Posts: 259

I don't have an issue with company values being clearly outlined, communicated and lived by, when fully embraced I believe they can be a positive differentiator. However, I do have an issue (or several) with this update. I don't want to believe this is Wolgen's work... I expect more from him. Perhaps he is super busy with the FDA submission and just gave this the rubber stamp? I sincerely hope he is not relaxing his standards in other areas - read FDA submission!

The Values read to me like a (confused) MBA assignment. I recall a previous announcement stating greater investment in people development and perhaps someone more junior has been the driving force behind this work as part of some learning or formal study? I have no idea why the Values have been overly complicated (they don't even fit on one page!) and turned into a 'Values System'. IMO a simple one page Company Charter capturing purpose, values and approach is all that was needed. BHP has a great example of this https://www.bhp.com/our-approach/our-company/our-charter


I believe the Values could have been summarised much more succinctly, and I made an attempt to re-work them over lunch, see below.

C ommitted (We aim to be sincere in our approach and represent data and facts. We act respectfully and do not harm others.)

L earning (We aspire to create an environment where professionals are able to develop and grow. etc)

I nclusive (Operate on the basis of gender and ethnic equality. Cherish diversity, equality, respect and harmony)

N ovel (innovation, through tech)

U nity (We strive to build international teams. We value our colleagues and co-workers)

V irtue (respect, We wish to set an example of excellence in our industry.)

E xcellence (We are determined to remain leaders in our field of expertise, and be creative and diligent in all our endeavours.)

L egacy (Through diligence and integrity we advance and serve the people.)


Perhaps we should test their new values?
I know many here have previously contacted the company to obtain information such as a copy of the share register or information about voting rights for CLVLY shares. Will our requests and emails continue to go unanswered...?
"We aim to be sincere in our approach and represent data and facts. We act respectfully..."

Finally, I made a quick attempt at trying to summarize what I believe is wrapped up in the new (way too busy and probably unnecessary) logo, see below.
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investek
Posted on: Feb 20 2018, 11:18 AM


Group: Member
Posts: 259

Artemis is featured!

Seems that spijko site was the web designer. Logo is a little more refined but way too busy IMO. The rational will probably be that this is a 'group' logo and the pharma products will stick with the frilled neck lizard and the cosmetic/otc will use a clean style like the packaging I uploaded.

Thoughts?


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investek
Posted on: Feb 20 2018, 10:38 AM


Group: Member
Posts: 259

Can't be long now...
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investek
Posted on: Feb 14 2018, 12:23 AM


Group: Member
Posts: 259

I appreciate the enthusiasm however I'm trying to stay grounded...

1) I highly doubt CUV will make the ASX300 rebalance in March. From my calcs the average market cap would need to have been around $450mil for the preceding 6 months and I believe CUV will have fallen short. Also (I haven't run the numbers) however average daily volume traded (as a % of free float) may also be on the low side. I'm hoping for the Sept rebalance, assuming some further share price run-up, however I wouldn't mind being proven wrong next month!

2) Half yearly reports are not new, see last year's in the link below. I doubt we will get anything more than the statutory numbers.
https://www.asx.com.au/asxpdf/20170224/pdf/...94w4c94rs03.pdf

___________________________________________

I have taken info from the newsletter and AGM presentation (and some creative license) to try and give us at least one key milestone per month to look forward to this year. Let's see how they go keeping the self-imposed deadlines...

Feb - new website/ positioning
Mar - NDA submission
Apr - CUV 103 vitiligo results
May - FDA decision on priority review, Announcement of new products
Jun - Cutaneous Porphyria study kick off
Jul - Opening Analytical Lab Singapore?
Aug - Launch Clinuvel Skincare Solutions (2 distribution channels)
Sep - TGA filing (EPP)
Oct - Japan filing (EPP)
Nov - AGM
Dec - FDA decision?
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investek
Posted on: Feb 13 2018, 09:33 AM


Group: Member
Posts: 259

This month's update from the Scottish Medicines Consortium.
https://www.scottishmedicines.org.uk/About_...ns_news_release

Still no update on afamelanotide (since decision was challenged), however I thought the following was interesting.

QUOTE
5-aminolaevulinic acid hydrochloride (Ameluz) was accepted for use in the treatment of basal cell carcinoma (a low grade type of skin cancer) unsuitable for surgical removal. This treatment is a gel that is applied to the affected area and activated with photodynamic therapy, a red light source which is shone directly on to the skin.
 

Biofrontera AG ETR:B8F
http://www.biofrontera.us.com/ameluz/

Therapeutic indications
Treatment of actinic keratosis of mild to moderate severity on the face and scalp (Olsen grade 1 to 2; see section 5.1) and of field cancerization in adults.
Treatment of superficial and/or nodular basal cell carcinoma unsuitable for surgical treatment due to possible treatment-related morbidity and/or poor cosmetic outcome in adults.
http://www.ema.europa.eu/docs/en_GB/docume...WC500120044.pdf
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investek
Posted on: Feb 12 2018, 01:35 AM


Group: Member
Posts: 259

I think you could be onto something re: Blijdorp's B&S International being used as a distribution channel for Clinuvel Skincare Solutions.

Perhaps the "licensing of a product and/or an acquisition" that Wolgen mentioned at the AGM could be a complementary OTC skincare product or range... Artemis?!

I found some info on an "Artemis Skincare" also known as "Artemis of Switzerland", see links below, currently owned/made by "Intracosmed ag"
https://www.intracosmed.ch/en/home.html

QUOTE
Nature and high tech unite in ARTEMIS of Switzerland in a unique way

No compromise. That was the briefing for a skincare, which was clearly different. "The aim was to develop a skincare that completely meets the wishes of demanding women for optimum skin compatibility, visible results and luxurious enjoyment," says brand visionary Herbert Frommen. His ambitious idea was implemented by years of research work by a team of Swiss scientists. The result: divine, just like the name.

The origin: GODDESS ARTEMIS THE PROTECTOR

A strong, emotional and truly divine name that perfectly reflects the brand's intention. Artemis was the Greek goddess of hunting and the forest and the most modern woman who ever produced the myths surrounding Mount Olympus. She should have been close to nature, consistent and self-confident and so beautiful that Aphrodite was divinely angry with her. Its attractive properties make the goddess the perfect ambassador for the cosmetics brand, bringing a whole new quality to skin care:

ARTEMIS of Switzerland - exclusive to Douglas.

http://bit.ly/artemis1

An old cached version of http://Artemis-skincare.com
http://bit.ly/artemis11

The Artemis Story...
https://translate.googleusercontent.com/tra...zvU6y2ZVQX563AA

https://www.douglasshop.hu/markak/artemis/
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investek
Posted on: Jan 25 2018, 01:47 AM


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Posts: 259

Is it just me (and my biased/paranoid view as a CUV holder) or is there a conflict of interest within the NICE evaluation committee?

QUOTE
Francis Pang - Vice-President, Market Access, Biogen Idec
Francis studied health economics at the University of York (1995) followed by appointments as the inaugural Research Fellow in Pharmacoeconomics at the Centre for Health Economics, University of York and as Monbusho Scholar at the Department of Economics, Kyoto University, Japan.
Prior to joining Biogen Idec, Francis held various health economics and market access leadership roles at Abbott Laboratories, Takeda Pharmaceuticals and Shire Human Genetic Therapies.
Francis is currently pursuing his MBA at INSEAD.


QUOTE
Biogen, Inc. (previously known as Biogen Idec) is an American multinational biotechnology company based in Cambridge, Massachusetts, specializing in the discovery, development, and delivery of therapies for the treatment of neurodegenerative, hematologic, and autoimmune diseases to patients worldwide.

Emphasis above mine.

See slide 37, Francis Pang part of the NICE HST Lead Team
https://www.nice.org.uk/guidance/GID-HST10009/documents/1

Coincidentally today was the last day for comments to NICE
https://www.nice.org.uk/guidance/indevelopm...on/html-content

Why do I get the feeling NICE's final decision will remain a no? There just doesn't seem to be as much patient and support group noise as in the US. The mention from the MP in parliament signals a glimmer of hope however I'm not holding my breath. It wouldn't surprise me if there ends up being another battle in the courts (a la Germany) before UK patients are able to gain access.
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investek
Posted on: Jan 22 2018, 02:12 AM


Group: Member
Posts: 259

I appreciate the support and collaboration (esp. recent work by PunkassDerm!) when we all work together and leverage each other's strengths we are able to discover much more than any of us could individually!

There are many quality contributors to this board and they all deserve a big thanks! I won't mention any individuals (as I'm bound to miss some key people) but from the early day long termer's who made the board what it is, to the more recent contributors (from Europe, the USA and Australia), this forum has provided invaluable information to us all (many times before official channels). I'm sure we have all read information which has challenged our views, confirmed our biases, made us angry, happy, laugh (hopefully), taught us something new and been a reminder about how much more there is to learn.

For many years I only ever read the forum however I decided to start trying to contribute in a meaningful way as a means of saying thank-you to everyone who has posted valuable information, insights and opinion over the years.

I hope we see Clinuvel reach its true potential soon and long term investors are rewarded for the wait. Even more importantly hopefully SCENESSE becomes available to many more patients in need. Most are here to make a buck however think of the life-changing impact this drug is already having, it's great to be involved with a company doing some good in the world! Exciting to think about future applications and improvements to quality of life that may be possible.

GLTA!

---------------

I found the following interesting re:biotech patents
https://www.ncbi.nlm.nih.gov/pmc/articles/P...!po=73.0769
QUOTE
With the increasing emphasis that patent offices are placing on the utility of biotechnology inventions, applicants are now finding that applications that fail to identify specifically the utility of the invention are rejected
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investek
Posted on: Jan 20 2018, 06:12 PM


Group: Member
Posts: 259

Interesting to see that there are numerous patent applications for KPV, including several by L'Oreal!

I'm not sure how many have actually been granted however I did find this one...
https://www.pat2pdf.org/patents/pat6894028.pdf
http://www.google.com/patents/US6894028

Note: Inventor, Anna Catania and assignee ZenGen Inc.

I can't find too much on ZenGen Inc. except a few market announcements
https://www.eurekalert.org/pub_releases/200...z-zir100103.php

ZenGen.com no longer appears to be the same company...

--------------

WILD SPECULATION & CONJECTURE BELOW!

It seems ZenGen were unable to commercialise their products (not sure why??) however the patents might still be valid. Perhaps this is the acquisition/licensing deal Wolgen mentioned at the AGM?!

QUOTE
The Company will further expand through the licensing of a product and/or an acquisition. The objective is to increase the product offerings.


http://clinuvel.com/investors/news/item/do...426f0ef3f7eed87
p37
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investek
Posted on: Jan 20 2018, 01:23 AM


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Posts: 259

Building on the MSH -> IL-10 -> psoriasis treatment link, we also have the compelling anecdote from xray, see below.


Further to what we have uncovered on KPV I found this article interesting...
Dissection of the Anti-Inflammatory Effect of the Core and C- Terminal (KPV) -Melanocyte-Stimulating Hormone Peptides
http://jpet.aspetjournals.org/content/jpet.../2/631.full.pdf

So basically KPV is the last 3 components of alpha-MSH, Lysine (K) Proline (P) & Valine (V).

QUOTE
In conclusion, the melanocortin peptide KPV was able to inhibit PMN migration and generation of proinflammatory mediators in a model of urate peritonitis. This inhibition did not seem to be associated with MC-R activation and could be better explained by inhibition of IL-1 effects. Our results show that at least two pharmacophores, the core region (HFRW) involved in MC-R activation and the KPV C-terminal tripeptide, which is able to counteract specific cytokines. These findings are thus of fundamental importance for the drug developmental strategies, including determination of targets, exploiting the therapeutic potential attributed to MSH peptides.



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investek
Posted on: Jan 19 2018, 01:38 AM


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Posts: 259

Fantastic digging PunkassDerm! Thanks for your efforts, you've put my mind at ease!

The links below are to a couple of the supporting studies referenced in your previous posts.

http://bit.ly/tripeptide
p582

QUOTE
Structure of -MSH and related tripeptides
As illustrated in Fig. 1B, the tridecapeptide sequence of -MSH [molecular weight (MW), 1664.91] is contained within ACTH. The core amino acid sequence HFRW ( - MSH6–9) is moreover common in -, -, and -MSH and ACTH. Pharmacological studies using the frog (Rana pipiens) skin pigmentation bioassay disclosed that the minimal se- quence of -MSH required for the melanotropic effect of -MSH resides in this core amino acid sequence (8). Efforts have been made to create protease-stable -MSH analogs containing this core sequence with superpotent melanogenic effects such as [Nle4, d-Phe7] -MSH (NDP-MSH) (9). C- and N-terminal fragments of -MSH, on the other hand, were shown to have no melanotropic effect in frog and lizard skin bioassays (9). Surprisingly, C-terminal peptide fragments of -MSH, however, possess similar or even pronounced anti- inflammatory effects as full-length -MSH, as will be out- lined in detail below. These small molecular weight peptides include the N-acetylated and C-amidated tripeptide KPV (MW, 383.49) and several stereoisomers, i.e., dKPV, KPdV, KdPV, and dKPdV. A structurally related derivate is KdPT (MW, 344.41) in which the hydrophobic amino acid valine of KPV is substituted by the more polar amino acid threonine. Recent evidence indicates that KdPT has likewise potent antiinflammatory effects.



https://pdfs.semanticscholar.org/f629/c20f0...9e72836e662.pdf
p1002

QUOTE
An important example of the immunosuppressive capacity of -MSH is demonstrated by its effect on the outcome of the contact hypersensitivity (CHS) reaction (Fig. 8). Thus administration of -MSH, systemic or topical, suppresses CHS at both the elicitation and sensitization phases (138, 153, 209, 315, 349). In addition, when -MSH is applied before epicutaneous sensitization with haptens, it induces tolerance, which is hapten specific, since animals can be still sensitized with other antigens. The induction of hapten-specific tolerance by -MSH may be mediated by IL-10, because it is blocked by administration of anti-IL-10 antibodies (138).


See figure 8 below.
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investek
Posted on: Jan 18 2018, 12:48 PM


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Posts: 259

Thanks PunkassDerm, I appreciate your additions!

I feel good about CUVs patent protection on a topical transdermal melanotropin however I'm still dubious about efficacy.

Re: the Kirby info you posted see below a copy of my post from September, it seems Afamelanotide in a Kirby Transdermal Delivery didn't work!

QUOTE
I've been doing some research on the transdermal/topical efficacy of CUVs drugs regarding human use.
As most of you know information in this regard is scarce, I appreciate anything further you are able to find regarding CUV9900 or VLRX001 human trial results.

I had some luck finding info regarding the outcome of a dose escalation study of transdermal CUV1647 (EPT1647) from over 10 years ago! (Forgive me if this is known info)
http://www.asx.com.au/asxpdf/20051019/pdf/3stz1z9fgmqxt.pdf

The study used Ken Kirby's TDS technology which I believe is referenced in one of CUV's topical patents.
Initially I was excited when I read "The system has proven that it delivers its drug payload and releases it in a bio-available and active form reliably and efficiently."
https://pdfs.semanticscholar.org/68d6/dd38d...5647754fb25.pdf page 3
There is even what looks like a Melanotan spray pictured on page 2.

I was still dubious, due to the large molecular size/weight of CUV1647, so I kept digging until I found a PhD thesis on the very trial!
https://core.ac.uk/download/pdf/30695931.pdf

Basically topical CUV1647 did not work in human trials at all


I'm concerned that CUV9900 and VLRX001 aren't much smaller than CUV1647 and may struggle to penetrate the skin. A much smaller fragment may be different story and the patent granted should cover all derivatives?
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investek
Posted on: Jan 18 2018, 12:33 PM


Group: Member
Posts: 259

Apologies, I should have said 'inferred' from the patents.

The link below is to my best guess of the patent that relates to VLRX001 (there is another patent that explicitly mentions CUV 9900)
https://patentscope.wipo.int/search/en/deta...=PCTDescription
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investek
Posted on: Jan 18 2018, 02:08 AM


Group: Member
Posts: 259

I have re-read the AGM presentation and summarised a few points below that I skimmed over the first time but think are worthy of further discussion.
http://clinuvel.com/investors/news/item/do...426f0ef3f7eed87

1. Slide 36 states "Clinuvel has a majority stake in an experimental lab in Singapore, where a number of novel projects are being progressed, and will lead to the clinical development of a. CUV9900 b. VLRX001 both as topical and second-generation melanocortin (MC) products.

Note: Both topical! My concern with this is that CUV9900 is 927 g/mol and (from my approximation) VLRX001 is ~790 g/mol (based on information in the patents). I recall PunkassDerm posted some info regarding a couple of large size topical molecules in creams however I still have concerns about the ability of these molecules to pass through the Stratum Corneum. Has anyone found any additional evidence of large (500 - 1,000 dalton) peptides being successfully delivered transdermally?

2. Slide 40 states "CUV103 vitiligo results n = 18, Asian phenotype" and indicates a timing of ~April 2018

My concern with this is that (besides us waiting forever for these results, I believe that trial recruitment may have been an issue) with only 18 participants this trial is not statistically powered, and I think we will struggle to get any results with p values <0.05. That said Wolgen has stalled this trial for so long that if the results weren't any good why wouldn't he just bury the trial along with the others we never heard about.

So I'm guessing we'll see 'encouraging' results that are not statistically significant but add to the good safety record.

3. Slide 41 states "Launch Clinuvel Skincare Solutions (CSS), 2 distribution channels" and indicates a timing ~Sept 2018


Is this an OTC cosmetic?!! A new product (cream?) to be sold only in Asia with a secret formula (that won't ever be revealed?) (hence no new patents/details) You can't 'launch' without a product can you? So does this mean something will be available to be purchased publicly in 2019?? Why mention 2 distribution channels if you won't be selling anything? (What could they be, online and retail?) I don't think CSS will be selling CUV9900 (or VLRX001) as slide 36 indicates both topicals will be prescription (note the Rx) and slide 41 indicates that there will be a CUV9900 trial with results not due until after 2020. Maybe it's just afamelanotide in a cream? Afamelanotide won't penetrate the skin (so no 'drug' issues) but it could be sold as the first 'anti-aging' cream to contain a melanocortin!? Would be more honest than what many major skin care companies state today!

Interested in your thoughts...
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investek
Posted on: Jan 11 2018, 09:22 AM


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Posts: 259

Summary points from ASX announcement
- Stan's last full year as chair
- Wolgen to stay on to 2021
- Dr Emilie Rodenburger to be next CSO
- CUV will attract a wider audience in 2018, diversify, enter new markets
- CUV will launch its premiere non-Pharma products under private label (more in coming months)

Does all this indicate they are positioning to be acquired?
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investek
Posted on: Jan 11 2018, 09:00 AM


Group: Member
Posts: 259

http://www.asx.com.au/asxpdf/20180111/pdf/43qrc9jg0q1s5d.PDF

Letter from Stan
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investek
Posted on: Jan 6 2018, 09:52 AM


Group: Member
Posts: 259

The British Porphyria Association have released their latest newsletter
http://www.porphyria.org.uk/wp-content/upl...er_2017_WEB.pdf

Update on SCENESSE
Since our last newsletter in May the BPA have invested huge amounts of time in supporting the appraisals processes for SCENESSE in England (National Institute for Health and Care Excellence – NICE), Wales (All Wales Medicines Strategy Group – AWMSG) and Scotland (Scottish Medicines Consortium – SMC). The drug received marketing authorisation through the European Medicines Agency (EMA) for use in Europe in 2014. However, the relevant government bodies in the UK still have to decide whether they are happy to fund the drug on the NHS. For each country, the BPA were asked to provide a statement on EPP and outline the potential impact of SCENESSE on patients, as well as on carers and their families. This covered the effect on quality of life, including elements such as family life, economics, choice of careers, study options, amongst many others.

We would like to say a huge thank you to all of the patients involved in sharing their emotive EPP experiences to create strong and thought provoking submissions. We have had enormous support and collaboration from BPA committee members, EPP patients and patient organisations from around the world. Each country has a slightly different process and each has progressed at slightly differing speeds. At the time of publication, the following can be reported: Scotland (SMC): we were invited to submit a patient group statement and attend a patient involvement meeting in May, followed by the formal appraisal in June, where we had a significant voice in explaining the severity of EPP. We were acknowledged by SMC to have created a very strong submission. Disappointingly, the final decision has not yet been published by SMC and Clinuvel is still in discussion with them. We hope to hear more soon.

Wales (AWMSG): again we were invited to submit a patient group statement and patient testimonials, as well as attend a clinical and patient involvement meeting (CAPIG) in June. The appraisal was held at a public meeting in September, where the collated information was shared with the panel. At this public meeting, AWMSG recommended not to approve SCENESSE for use in Wales, as ‘the case for cost effectiveness was not proven’. However, this still needs to be ratified by government before a formal notification will be made. Clinuvel have lodged a request for an independent review and this has been granted, which means that ratification is delayed until afterwards. It is thought that this review will take place in January 2018.

England (NICE): NICE also invited the BPA to submit a statement, which was completed in June. SCENESSE is being assessed under the Highly Specialised Technology (HST) process, and we were able to nominate two people to attend the appraisal meeting on 23rd November in Manchester. A decision is expected to be made by May 2018. Whilst waiting for the outcomes of these processes, Clinuvel have been establishing the necessary systems to enable them to meet the conditions of the EMA’s exceptional circumstances approval, including establishing patient and disease registries, and setting up specialist treatment centres in the UK for controlled distribution. This means that, if approved, centres will be in a position to start administering the medication quickly.

Keep looking out for updates on our website and Facebook.
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investek
Posted on: Jan 4 2018, 12:49 AM


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Posts: 259

QUOTE
CRANBURY, N.J., Jan. 3, 2018 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE MKT: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, today announced that the U.S. Food and Drug Administration (FDA) has notified Palatin that it may proceed with its clinical investigation of subcutaneous injection PL-8177 as a potential treatment for patients with ulcerative colitis. The notice to proceed was received following Palatin's submission of an investigational new drug (IND) application for this program. Palatin expects to commence a Phase 1 single and multiple ascending dose study in the current quarter.

PL-8177, a selective melanocortin receptor 1 (MC1r) agonist peptide, is Palatin's lead clinical development candidate for ulcerative colitis and other inflammatory bowel diseases. Agents that modulate the MC1r system may have therapeutic potential in a variety of inflammatory disease indications.

"The FDA's acceptance of this IND application is an important milestone for Palatin, as we accelerate our drug discovery programs following the successful licensing of bremelanotide for hypoactive sexual desire disorder," said Carl Spana, Ph.D., president and chief executive officer of Palatin Technologies. "We are excited about the potential of modulating the melanocortin system in the treatment of a wide variety of diseases, and have multiple programs to develop melanocortin based therapeutics for patients with inflammatory diseases."

PL-8177 is a cyclic peptide that has demonstrated efficacy in animal inflammatory bowel disease models. Palatin has developed an oral formulation of PL-8177 that has been validated in animal studies, and is scheduled to be explored in future clinical investigations. PL-8177 is highly specific for MC1r, with sub-nanomolar affinity binding and EC50 functional values.

https://www.prnewswire.com/news-releases/pa...-300576748.html
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investek
Posted on: Jan 2 2018, 05:42 PM


Group: Member
Posts: 259

Thanks Sharelooker.

Agreed, not the news we were after to kick off 2018!

Seems Sharelooker's page is one of Norwegian law (based on Google translate). I've been monitoring the link below from time to time, Norwegian 'New Methods'
QUOTE
New Methods are the following actors; the regional health authorities, the Norwegian Institute of Public Health, the Norwegian Medicines Agency, the Norwegian Radiation Protection Agency and the Norwegian Directorate of Health. The actors work on behalf of the Ministry of Health and Care Services, which is the system owner


The page still indicates "For Method Assesment" however the status have been like that for a long time... might be worth making contact to get clarification
https://translate.googleusercontent.com/tra...OKjmHOocunRxyrA
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investek
Posted on: Dec 31 2017, 05:19 PM


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Posts: 259

Nice find PunkassDerm, thanks for sharing!

I notice that one of the authors is Anna Catania, a leader in the melanocortin field. The link below is to some of her other work, it's a bit dated (2010) however it gives a very thorough overview of all the melanocortins and many mechanisms of action.
http://bit.ly/AnnaCatania
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investek
Posted on: Dec 30 2017, 02:53 AM


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Posts: 259

Nice find Clinhope!

I think we may be over-thinking it! The screen-shot you included states what the likely non-health-related benefits are "such as improving employment and study options" It is interesting that the screenshot says "despite taking those benefits into account" whereas I'm sure somewhere else in the report they state that the model excludes increased wages, lower reliance on state welfare, etc.

I think the main issue with NICE is just the current obsession with wanting to use their standard QALY model, not being happy with the bespoke EPP questionnaire and DALY scoring (including the grouping of patients into mild, moderate and severe) and probably above all pressure/mandate to reduce costs!

Re: the CUV Google Group disappearing I haven't made contact with Uhohinc however I did notice many spam posts appearing offering xanax and other drugs in recent days. Uhoh was removing these quite promptly though so not sure why the group appears offline, however this is the error message I get:

QUOTE
Banned Content Warning
The group that you are attempting to view (Clinuvel Afamelanotide Scenesse Vitiligo Porphyria CUV ASX.CUV CLVLY ur9) has been identified as containing spam, malware or other malicious content. Content in this group is now limited to view-only mode for those with access.
Group owners can request an appeal after they have taken steps to clean up potentially offensive content in the forum. For more information about content policies on Google Groups, please see our Help Centre article on abuse and our Terms of Service.
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investek
Posted on: Dec 28 2017, 12:27 AM


Group: Member
Posts: 259

Ok so I've finished reading the NICE HST prelim evaluation report on afamelanotide for treating EPP and think I managed to decipher one more piece of the puzzle!

I also found a link to a good summary of QALY, http://www.valueinhealthjournal.com/articl...Fshowall%3Dtrue

The 'QALY gain' in the base case (Scenario 1.0) is ~3.22.

I calculated this by using Table 32 - simple QALY results (page 416) and Table 38 Undiscounted QALY results (page 444). I've copied the two key variables from these tables (QALY Gain & £/QALY) into a new (grey) table below for ease of reading.

The screen shots that follow explain the basic relationship between Implant cost, QALY Gain, £/QALY, years of treatment and number of implants. By substituting in the known values for Scenario 1.0 we can calculate the QALY Gain.

Assumptions / deductions:
Cost per implant (plus admin. & monitoring) = ~£12,675 (p384)
No. implants / yr (Base Case) = 2 (see my previous post)
Number of years of treatment = 35 yrs (p389 & 444)

I believe CUV has a convincing argument that 'gain in QALYs' does not adequately capture the benefit received by patients. Furthermore I believe the 'gain in QALYs' would be far greater in children (if you could measure it) as they may not yet have changed their behaviour as permanently to avoid sunlight. The sad thing is NICE is slowing development for a paediatric treatment by not recommending reimbursement by the NHS for adults now. This is becoming more a case for basic human rights for EPP patients in the UK than a cost benefit equation.

I think logic will ultimately prevail and patients in the UK will get access to a much needed treatment, I'm just not sure this will occur in May 2018, it may take a bit longer for NICE to come to their senses!
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investek
Posted on: Dec 24 2017, 05:06 PM


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Posts: 259

The blacked out info has been hidden because CUV deem it commercially sensitive.

The report doesn't state (openly) that the Base Case is two implants, that is what I had to deduce!

So there are two pieces of info you can use to figure out the base case no. of implants (however you really only need the second one).

1) In your first screen shot below with the redacted content in blue it states "The company estimated the number of implants per year as *** in the base case.
Note the 3 asterisks! We know (from previous reports) that either 1,2,3,4 (or 5) implants will be administered. Only numbers 'one' and 'two' have 3 letters, which corresponds to 3 asterisks.

2) In your second screen shot below it states "New scenario analyses were conducted altering the number of implants to 0, 1, 3, or 4 per year." This is really all we needed to see. If the new scenarios use 0, 1, 3, or 4 implants per year the only logical number for the base case is 2!

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investek
Posted on: Dec 23 2017, 01:44 AM


Group: Member
Posts: 259

I've read about half of the NICE HST prelim evaluation report on afamelanotide for treating EPP and I think I've managed to decipher two of the redacted pieces of info (not sure what that tells us) and one other tidbit. https://www.nice.org.uk/guidance/GID-HST100...ommittee-papers

1. Base case is two implants per year, see screenshot below or page 181 of the report. This is slightly concerning as I believe this number is justified from the real world use data. I recall a reference of the Netherlands prescribing up to 5 implants per year. I had assumed ~3-4/yr average however 2/yr may explain the high degree of seasonality we are observing in sales.

2. In the base case, "Anxiety Disorders" were used as the proxy for disability weighting in the DALY calculation. This can be seen from the second screenshot below that references anxiety (page 213) and/or page 159 by looking up the 2010 GBD disability weights of 0.03 (mild), 0.149 (moderate), 0.523 (severe). http://dcp-3.org/sites/default/files/chapt...20Disorders.PDF
Not sure why this info was hidden, seems like a decent proxy to me!

3. CUV is positioning for a legal battle (if need be). Note: the cc on several letters, Maria Manley from Bristows LLP. "Maria is experienced in coordinating EU and overseas litigation. Currently representing a leading pharma company before the EU Court against a decision by the EU Competition Commission and in an action before the English courts."

So my takeaways from this are that I expect sales to grow more slowly this year, maybe FY18 revenues come in at ~$22-25mil, as Lachlan and co. are pre-occupied with regulatory red-tape rather than driving sales, and when sales do occur they are likely only 2 implants per year per patient. CUV's legal justification seems sound, not sure if it will ultimately win over NICE however Wolgen has done this before in Germany. I think NICE debate will drag out much longer than May 2018 through appeals etc. unless more senior NICE staff get involved early next year. I see little incentive for NICE to change their tune unless under duress, need that patient voice more than ever!

Overall I feel better about the upcoming FDA NDA decision having read this report, but worse about near term sales.

Merry Christmas and a happy, healthy and prosperous New Year to all!
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investek
Posted on: Dec 20 2017, 11:28 PM


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It is interesting that NICE decided to allow Translarna via the NHS, a drug that costs more than double SCENESSE and also had patient input in the EMA process and was approved under 'exceptional circumstances' (and I believe has not been approved by the FDA). The UK seems to have had a grudge against CUV from the outset! (Weren't they one of the EMA members to vote against approval?!)

I agree the UK patient groups really need to make some noise now! Maybe they need some help from Ms Lyons? I get the feeling the evaluation committee does not fully appreciate how debilitating EPP can be. One of the comments from the FDA EPP meeting is stuck in my mind, when a mother says that she "was not aware her son had a broken bone because he could not feel it over the pain from EPP reactions!"

I'm sure Wolgen won't let this rest, time to earn all those shares that were gifted to him!

NICE backs PTC's muscular dystrophy drug Translarna
Drug to be available on the NHS for DMD patients aged five and over
21st July 2016

QUOTE
The UK's cost-effectiveness watchdog has backed the use of Translarna (ataluren) for DMD patients aged five and over whose disease is caused by 'nonsense' mutations and who are able to walk, provided the drug is prescribed within the terms of a managed access deal based on 'financial and clinical details'.
Translarna remains the only treatment to be approved for marketing - after a series of setbacks for other late-stage clinical candidates - that modifies the underlying cause of DMD and it is estimated that around 50-60 children could receive the drug over five years under NICE's access plan.
The drug has a list price of £220,000 ($290,000) a year, and it is understood the access deal includes an agreed discount as well as a commitment by PTC to generate real-world evidence on the drug's benefits over the five-year period. Thereafter a new finding decision will be made.


http://www.pmlive.com/pharma_news/nice_bac...IGN_NAME=2&
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investek
Posted on: Dec 15 2017, 01:17 AM


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Posts: 259

QUOTE
The Chairman informed members that an independent review panel would be convened early in the New Year to investigate complaints submitted by Clinuval Pharmaceutial Limited following the announcement of AWMSG’s recommendation on 13th September 2017 that afamelanotide (Scenesse) for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria is not supported for use within NHS Wales.


http://awmsg.org/meetingszip/AWMSG%20meeting%20papers.pdf

They say "a panel will be convened early in the New Year" however I highly doubt AWMSG makes any big decision before NICE decision in May.

We continue to wait... any news on additional clinics / countries online in Europe? Perhaps we can team up and make some calls to the Centres below...
http://porphyria.eu/en/content/specialist-...-laboratory-map
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investek
Posted on: Dec 8 2017, 07:22 PM


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I highly doubt CUV will qualify for inclusion in the ASX300 rebalance in March 2018.

Without looking in great detail it appears market cap will be a tad too low (from memory the 300th largest company in the all ords is ~$400 - 425mil atm) and I believe average daily trading volumes as a percentage of free float will come up shy also.

Perhaps Sept 2018, however I'm not holding my breath. That would likely require sustained share price above $9 and higher volumes like we saw pre AGM for an entire 6 month period...
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investek
Posted on: Dec 3 2017, 06:17 PM


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Prepare for an FDA advisory committee meeting as part of the NDA evaluation...

An advisory committee (AC) is mentioned on slide 23 of the AGM presentation. I don't think this is a bad thing, however good to be aware of. There seems to be a strong correlation between the AC recommendation and the final NDA outcome and speed of decision (the more in favour the AC, the faster the decision). See extracts/links below:

QUOTE
3.3.4 Finalize Need for Advisory Committee (AC)
Under FDAAA, an Advisory Committee meeting must be held for all NMEs and original BLAs, unless an adequate justification is documented explaining the decision to not hold a meeting (for NMEs and Original BLAs, this reason is to be included in the approval letter). For other applications the review division, in consultation with the office director, may decide to convene an Advisory Committee meeting. A review division may need AC input, for example, when: 1) the clinical trial design used novel clinical or surrogate endpoints; 2) the application raises significant issues on the safety and/or effectiveness of the drug or biologic; or 3) the application raises significant public health questions on the role of the drug or biologic in the diagnosis, cure, mitigation, treatment, or prevention of a disease.

https://www.fda.gov/downloads/AboutFDA/Cent...s/UCM218757.PDF

QUOTE
With regard to novel drugs, 37% of FDA-approved new chemical entities or new biological entities in the 2001–2010 period were the subject of an advisory committee meeting. This percentage increased from 32.8% in the 2001–2005 period to 41.4% in the 2006–2010 period, suggesting a slight increase in the FDA’s use of advisory committee input to help inform product approval decisions. Additional data analysis shows that new biologics, priority status applications, and orphan drugs were the subject of more meetings, on a percentage basis, than new chemical entities, standard applications, and non-orphan drugs.

The FDA’s approval decisions have been broadly consistent with the recommendations of its advisory committees. The FDA approved 88% of the original NDAs or BLAs that were endorsed by its advisory committees, and did not approve 86% of those that the committees did not endorse.

The association between the strength of the endorsement by the committee (as measured by the percentage of panel members voting for approval) and the duration between the advisory committee meeting and FDA approval date is shown in Exhibit 2c. As might be anticipated, the duration varies inversely with the strength of the endorsement, suggesting that strongly endorsed products tend to be approved on the first review cycle, whereas products that are not as strongly endorsed could be associated with multiple review cycles


https://www.mckinsey.com/~/media/McKinsey/d...e_outcomes.ashx

https://embed.topra.org/sites/default/files...s-cox-scott.PDF
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investek
Posted on: Nov 24 2017, 11:11 AM


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Thx, you have mail.
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investek
Posted on: Nov 21 2017, 09:55 PM


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Posts: 259

Controvers, love your enthusiasm as always however I suggest taking it down a few notches.

Many of the articles you have provided links to are written by bots/algorithms.

Just over a year ago I posted about the potential for CUV to be added to the ASX300 (http://www.sharescene.com/index.php?showtopic=27&view=findpost&p=866356) this will likely need to happen before addition to the ASX200. Whilst CUV has a current market cap that is likely high enough to qualify for the ASX300 I'm not confident that the current volumes are high enough to enable addition to the index at the March 2018 rebalance. I think September 2018 is much more likely, however I said that a year ago and look what happened!

If you are interested you can read up on the liquidity requirements in the link/extract below.
http://us.spindices.com/documents/methodol...ian-indices.pdf


Also some Dutch cheerleading for you, looks like Amsterdam will be the future home of the EMA!
https://mobile.the-scientist.com/article/50...ve-to-amsterdam

I also received confirmation from a friend that he attended a prior CUV AGM (several years ago, 2014?) as a non-holder. (He has since bought shares)

GLTA
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investek
Posted on: Nov 21 2017, 09:20 PM


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I think you could be on to something Royco!

I've been wondering something similar for a while, particularly around one indication you failed to mention, arteriosclerosis!
Refer the study below courtesy of Uho on gg.
http://atvb.ahajournals.org/content/atvbah...305064.full.pdf

I need to brush up on my stats, can anyone estimate how many EPP patients need to be monitored and over what time period in order to see a statistically significant (p<0.05) prophylactic effect from SCENESSE in preventing/reducing arteriosclerosis?

Surely with such a high prevalence of heart disease in the general population it would not take a very large sample size to demonstrate? Also I wonder if there is a link in higher functioning/sensitivity MCR1 and lower heart disease? We've all heard of the supposed link between the Mediterranean diet and heart health, what if it's the olive skin that is linked to heart health?
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investek
Posted on: Nov 21 2017, 06:13 AM


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From memory even non-holders can attend, just not allowed to ask questions or vote. All attendees need to register at the door but it's straight forward and takes about 2mins.
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investek
Posted on: Nov 14 2017, 12:58 AM


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Still no update/decision on Afamelanotide from the Scottish Medicines Consortium.
Links below to November decisions and medicines with advice withheld (SCENESSE still on the list)

Medicines with advice withheld pending product availability
https://www.scottishmedicines.org.uk/SMC_Ad...tegory?term=All

QUOTE
November 2017 decisions news release
SMC accepts three new medicines for use by NHSScotland
The Scottish Medicines Consortium (SMC), has today (Monday 13 November) published advice accepting three new medicines for use by NHSScotland.

https://www.scottishmedicines.org.uk/About_...ns_news_release

Looks like it's all down to NICE and we'll be waiting until May 2018.
First evaluation meeting in a couple weeks.

QUOTE
Highly specialised technologies evaluation committee meeting
23 November 2017
NICE, Level 1, City Tower, Piccadilly Plaza, Manchester, M1 4BT

https://www.nice.org.uk/event/hst-november-2017
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investek
Posted on: Nov 12 2017, 04:06 PM


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Latest OptumRx Brand Pipeline Forecast - Q4 2017
https://www.optum.com/content/dam/optum3/pr...ineForecast.pdf

SCENESSE p16, no changes from last quarter

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investek
Posted on: Nov 12 2017, 02:46 PM


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Great find controvers! Thanks for sharing.

A few of the points that stood out to me are included below.

QUOTE
Taken together over one-quarter of these orphan approvals received breakthrough therapy designation and nearly three-quarters received priority review



QUOTE
2017: A year of FDA “firsts” in Rare Disease
• tisagenlecleucel – First gene therapy approval in the United States
• avelumab - First FDA-approved treatment for metastatic merkel cell carcinoma
• lesipasvir + sofosbuvir - First HCV Direct-Acting Antivirals approved for use in adolescents
• cerliponase alfa - First FDA- approved treatment for a form of Batten disease
• edaravone - First new treatment for patients with ALS in over 2 decades
• ibrutinib – First FDA-approved therapy for the treatment of chronic graft-versus-host disease (GVHD)
• benznidazole - First treatment approved in the United States for the treatment of Chagas disease

Let's hope this continues in 2018!

QUOTE
FDA Orphan Drug Approvals by Submission Type
• Both novel and new indication Orphan Drug approvals have increased in recent years.
• Pace of annual novel Orphan approvals has doubled since 2011.
• New indication approvals have greatly increased beginning in 2013

How Often Do Orphan Drugs Expand Approved Labeling to Treat Other Conditions?
• Nearly three-fourths of drugs initially approved as an orphan drug have not expanded their labeled indication.
• 85% of drugs approved for orphan diseases have not expanded to other conditions.
• Fewer than 10% of initial orphan approvals have added a non-rare indication to their label.

Some High Revenue Drugs Have Orphan Indication(s)
• Humira
• Enbrel
• Remicade
• Crestor
• Neulasta
• Copaxone
• Rituxan
• Avastin
Majority of these examples of top selling orphan drugs are products that were first approved to treat non-rare diseases

Question: Do these highest-revenue orphan drugs expand their labeled indications similar to other orphan drugs?
Most of the highest-revenue orphan drugs received a much greater number of expanded indication approvals than is typically experienced with orphan drugs.


6 drugs are highlighted with between 6 and 15 new indications (Humira and Remicade, 14 & 15 new indications after approval).

Based on the information within the patents and already granted orphan designations I count more than 6 potential additional indications after EPP for CUV...
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investek
Posted on: Nov 10 2017, 05:13 PM


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