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sharelooker
Posted on: Yesterday, 06:04 PM


Group: Member
Posts: 432

QUOTE
B.2.2. Renewals of Marketing Authorisations for unlimited validity

SCENESSE - afamelanotide -
EMEA/H/C/002548/R/0026, Orphan
Clinuvel Europe Limited, Rapporteur: Janet
Koenig, Co-Rapporteur: Alexandre Moreau, PRAC
Rapporteur: Martin Huber


https://www.ema.europa.eu/en/documents/agen...-meeting_en.pdf
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sharelooker
Posted on: Jul 22 2019, 07:35 PM


Group: Member
Posts: 432

http://www.buysellsignals.net/BuySellSigna...lia_pdf_623.pdf
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sharelooker
Posted on: Jul 21 2019, 07:50 AM


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Posts: 432

Updated!

https://www.barrons.com/quote/stock/au/xasx/cuv
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sharelooker
Posted on: Jul 20 2019, 05:42 AM


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Posts: 432

https://www.volkskrant.nl/de-gids/voor-mens...-pijn~b7582656/
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sharelooker
Posted on: Jul 15 2019, 03:01 AM


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Posts: 432

I'm not really sure about this but overall this mutual CMC/GMP agreement is a very good sign. CUV probably transferred the Catalent CMC procedures to the Birmingham facility in the US. These protocols are already fully validated and should be accepted by the FDA!
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sharelooker
Posted on: Jul 14 2019, 10:28 PM


Group: Member
Posts: 432

According to the leaflet, the implants are manufactured at Catalent Germany Schorndorf GmbH and Catalent UK Packaging Ltd.
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sharelooker
Posted on: Jul 14 2019, 09:29 PM


Group: Member
Posts: 432

US and EU Fully Implement Mutual Agreement on GMP Inspections
Posted 12 July 2019 | By Zachary Brennan


https://www.raps.org/news-and-articles/news...greement-on-gmp
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sharelooker
Posted on: Jul 13 2019, 09:17 PM


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Posts: 432

https://www.gurufocus.com/news/907936
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sharelooker
Posted on: Jul 11 2019, 01:07 AM


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Posts: 432

The FDA's Janet Woodcock talks about some big changes she's pushing for in drug development, and agency reviews

Janet Woodcock is perhaps the most influential regulator at the FDA. And when the head of CDER talks about the changes being made at the agency when it comes to clinical trial designs, or the need to reorganize for a specific disease arena, an assessment of the expansion of gene therapy or I/O, common development mistakes, and so on, you can be sure the industry pays attention to every word.


Geoffrey Porges
So it was with some eagerness that I opened up Geoffrey Porges’ summary of their recent conversation about the FDA. And I wasn’t disappointed. In a wide-ranging exchange with the SVB Leerink analyst, Woodcock discussed the growing importance of patient-reported outcomes in clinical trials, a campaign underway now to see if CROs would help spur more basket studies to compare drugs head-to-head, and much, much more.

And she’s offering some insights into the FDA’s thinking that could prevent a lot of setbacks in the future. At the risk of losing a lot of the nuance of his detailed review, here are the highlights I came away with. The italics are mine:

 The FDA may still prefer the classic, randomized clinical trial, comparing a drug against a placebo as the purest way to determine a treatment effect, but Woodcock says that the patients enrolling for a study don’t like it at all. And neither do many of the developers. “In fact, the FDA recognizes that many patients do not want to potentially receive a placebo, and understands the difficult logistics industry could encounter with a placebo design. As a result, the FDA is supportive of non-inferiority and other trial protocols, such as dose comparisons and delayed start trials.”

Basket studies, testing multiple drugs in a head-to-head comparison, are a distinct favorite at the agency. But the developers tend to steer clear, preferring a single agent approach. “The FDA has reached out to the industry’s contract research organizations (CRO) to test the waters for feasibility, but Dr. Woodcock ultimately believes it will be patient groups that drive such a radical change.”

Where do biopharma companies fail most frequently? This is one of my favorites, which underscores several themes you’ll find in our coverage. Porges note on Woodcock’s remarks: “For the clinical deficiencies, it is most common to see companies push for biomarker endpoints that have not yet been validated as correlated to outcomes that matter for patients or physicians. Dr. Woodcock also offered that the clinical and regulatory teams at both large and small companies sometimes delude themselves into believing that further development of certain drugs, or indications, can be supported by retrospective subsets from prior studies. In many cases the FDA sees these post hoc analyses leading to erroneous conclusions.”

Woodcock voiced particular frustration with the way the booming immuno-oncology field handles trials. Notes Porges: “For example, she suggested they have primarily been used as dictated by the protocols of the original trials, but wondered if these agents that affect the immune system would be better used with upfront or intermittent dosing. She also expressed concern that adequate biomarkers and the time to onset of response is poorly understood. Finally, she opined that it is unclear whether all of the PD-[L]1 agents are truly different or just various iterations of each other. However, the FDA does not have the ability to answer these questions, many of which could reduce the value of these assets, without the buy in from industry.”

Patient-reported outcomes are a major theme now at the FDA. Woodcock discussed a coming guidance on trial design around patient-focused clinical design work. “The FDA hopes to combine these endpoints with more robust natural history studies to “conduct better trials that are more feasible and will be studying outcomes that matter most to patients. And [the FDA] is going to accept that kind of endpoint”. Dr. Woodcock also suggested many trials are designed without input from the patient community, which has led to difficult enrollment or high dropout rates.”

The recent surge of new approvals at the FDA is not seen as a temporary phenomenon. Regulators are prepping for a future with even more new drug OKs each year, particularly as fields like gene therapy expand rapidly And that requires some rethinking of the process. First, CBER may well be underfunded if the growth trend plays out. And the agency is examining how it reviews new drug/device combinations, to make sure it’s handled in the most effective manner. “(T)he shift towards multimodal interventions, such as drug-device combos, may require a restructuring at the FDA to better review these complex applications that span expertise and insight in different branches or divisions of the Agency.”

The reorganization of the FDA’s Office on New Drugs — which has to be cleared by lawmakers — includes a new office for neurosciences. While trial failures appear to dominate in this field (my comment), the agency sees a lot of similarity in the field related to pathways, drugs and targets. And there’s plenty of more work coming: “The FDA has pushed for this new division due to a recognition that neuroscience is an ‘up and coming’ field where we will see ‘tremendous advances’.”

Single arm studies for rare and serious diseases, using a historical comparison, sometimes make a lot of sense — and sometimes don’t. A lot depends on what regulators and experts know about the natural history of the disease and the availability of a good biomarker to test the drug against. That can work particularly well in advanced cases of drug-resistant cancer, because the regulators understand the way the disease typically progresses. In ALS, she uses as an example, that doesn’t work so well, but patients are also satisfied with small effects, which the agency wants to keep in mind.
There’s a lot more in Porges’ assessment. He is thorough.

July 10, 2019 09:37 AM EDTUpdated 10:21 AM
AUTHOR
John Carroll
EDITOR & FOUNDER


https://endpts.com/the-fdas-janet-woodcock-...agency-reviews/
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sharelooker
Posted on: Jun 30 2019, 11:57 PM


Group: Member
Posts: 432

Evonik has opened a skin laboratory in singapore focussing on tissue engineering and the development of skin models that are crucial for testing new API's. Maybe more collaboration with CUV ahead??

QUOTE
However, the demand for laboratory-engineered skin goes far beyond the area of clinical applications. There is also a need for optimized approaches for so-called skin models, realistic replicas of the human skin that are employed for research and testing purposes in laboratories, for example to test new cosmetic ingredients, cleaning agents or chemicals.


https://corporate.evonik.com/en/pages/artic...rticleId=114060


https://corporate.evonik.com/Downloads/Corp...%B6nig%20en.pdf
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sharelooker
Posted on: Jun 22 2019, 06:35 PM


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Posts: 432

QUOTE
Analysts don’t expect Vyleesi to fare much better. The drug does not have Addyi’s safety concerns, but the fact that it must be injected could be a major barrier to potential patients, according to SVB Leerink analyst Ami Fadia. Ken Cacciatore, an analyst at Cowen, wrote in a note to investors that he expects Vyleesi’s commercial performance to “materially disappoint.”


https://www.statnews.com/2019/06/21/fda-app...ns-libido-drug/
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sharelooker
Posted on: Jun 22 2019, 07:10 AM


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Posts: 432

PTN is up almost 60% in the after-hours trade! It seems that Vyleesi was approved by the FDA!

https://www.marketwatch.com/investing/stock/ptn

https://www.fda.gov/news-events/press-annou...enopausal-women
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sharelooker
Posted on: Jun 21 2019, 08:22 PM


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Posts: 432

PTN down 18% in premarket trade!
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sharelooker
Posted on: Jun 20 2019, 09:57 PM


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Posts: 432

Re PTN/AMAG

https://www.statnews.com/2019/06/20/women-s...-bremelanotide/
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sharelooker
Posted on: Jun 17 2019, 05:36 PM


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Posts: 432

https://finance.yahoo.com/news/why-clinuvel...-203655923.html
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sharelooker
Posted on: Jun 16 2019, 12:08 AM


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Posts: 432

Another ETF that tracks the S&P/ASX 200 index:

Lyxor Australia S&P/ASX 200 UCITS ETF
https://www.bloomberg.com/quote/LAUU:LN
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sharelooker
Posted on: Jun 14 2019, 08:02 AM


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Posts: 432

Congrats, waz!!Good job!

https://us.spindices.com/documents/indexnew...e_download=true
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sharelooker
Posted on: Jun 13 2019, 04:59 AM


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Posts: 432

https://freeshkreli.blogspot.com/2019/06/
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sharelooker
Posted on: Jun 12 2019, 07:03 AM


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Posts: 432

'Can we teach old drugs new tricks? –Repurposing of neuropharmacological drugs for inflammatory skin diseases'
07 June 2019
https://onlinelibrary.wiley.com/doi/epdf/10.1111/exd.13987
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sharelooker
Posted on: Jun 11 2019, 07:03 PM


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Posts: 432

https://thebull.com.au/asx-gains-102-points-in-broad-rally/
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sharelooker
Posted on: Jun 11 2019, 06:51 PM


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Posts: 432

CLINUVEL PHARMACEUTICALS LTD HOLD
Minimal concerns over FDA delay


https://www.sharecafe.com.au/wp-content/upl..._CUV-report.pdf
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sharelooker
Posted on: Jun 11 2019, 06:57 AM


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Posts: 432

'CBUS Super', a large australian auperannuation fund, is now on board with 83k shares.

Source: Morningstar
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sharelooker
Posted on: Jun 6 2019, 07:45 PM


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Posts: 432

Updated ownership table at morningstar. Credit Suisse is now on board with a few shares.

https://www.morningstar.com/stocks/pinx/clvlf/quote.html

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sharelooker
Posted on: Jun 6 2019, 06:45 PM


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Posts: 432

What about PME? Their market cap and average trade volume is even higher compared to CUV and they're still awaiting asx200 listing.
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sharelooker
Posted on: Jun 4 2019, 06:48 AM


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Posts: 432

Yes, you are right but in this case, it was a sBLA as a first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC).
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sharelooker
Posted on: Jun 4 2019, 06:37 AM


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Posts: 432

All NDAs/sNDAs/BLAs/sBLAs with a 3-month PDUFA extension since Ocober 2016:

https://investor.sagerx.com/news-releases/n...pdufa-extension

https://investor.incyte.com/news-releases/n...iod-ruxolitinib

http://ir.acorda.com/investors/investor-ne...od/default.aspx

https://www.daiichisankyo.com/media_investo...ail/006995.html

https://www.allergan.com/news/news/thomson-...ulipristal.aspx

http://ir.lipocine.com/U-S-FDA-Extends-Rev...mains-Unchanged

https://investors.karyopharm.com/news-relea...d-selinexor-new

https://www.gene.com/media/press-releases/1...lication-for-oc

https://www.kyowa-kirin.com/news_releases/2...20180530_01.pdf

https://ir.bauschhealth.com/news-releases/2018/02-09-2018

https://investors.merck.com/news/press-rele...al/default.aspx

https://ir.akceatx.com/news-releases/news-r...s-first-quarter

https://www.businesswire.com/news/home/20180523005645/en/

https://investors.biomarin.com/2017-12-22-B...-to-May-28-2018

https://www.eisai.com/news/2018/news201839.html

https://investor.lilly.com/news-releases/ne...investigational

https://theratechnologies.s3.amazonaws.com/...20171113-en.pdf

https://news.bms.com/press-release/corporat...gulatory-review

Almost all drugs have been approved after the 3-month extension period (mostly due to CMC issues) including blockbusters like Ocrevus and Keytruda. So I think, the probability of approval is even higher now than before the recent asx announcement. Don't worry, folks. Take your sleeping pills until October
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sharelooker
Posted on: Jun 4 2019, 05:14 AM


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Posts: 432

Does anyone have access to this article? Is it worth reading it or is it just a copy of the asx announcement?

https://pink.pharmaintelligence.informa.com...r-Phototoxicity
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sharelooker
Posted on: May 31 2019, 03:04 AM


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Posts: 432

Principles of cuntaneous immunology and immunotherapy is effective in skin cancer;
https://www.youtube.com/watch?v=tf_jOLjcdbg

Targeting of Antigen Presenting Cells for Tumor Immunotherapy;
https://www.youtube.com/watch?v=6qxenfx0BHs
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sharelooker
Posted on: May 31 2019, 02:39 AM


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Posts: 432

Great find, Odi01!
Dr. Grabbe has much expertise in the field of melanocortins. In the late 90s he worked with Dr. Luger (University of Muenster) on dendritic cells that express the melanocortin receptors MC-1R which are possible targets for treating multiple sclerosis. I believe that Mainz as an EPP-center is strategically planned because it has all the requirements for future research on SC beyond EPP.

https://de.wikipedia.org/wiki/Stephan_Grabbe

https://www.researchgate.net/profile/Stepha...;sorting=recent

https://www.researchgate.net/publication/12..._Receptor_MC-1R
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sharelooker
Posted on: May 27 2019, 10:21 PM


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Posts: 432

There will be two more conferences next week:

15th Sun Protection Conference
Agenda: https://summit-events.com/assets/files/Sun-...rogramme-v1.pdf

Jefferies 2019 Heathcare Conference
Agenda: http://www.jefferies.com/CMSFiles/Jefferie...0Agenda(10).pdf

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sharelooker
Posted on: May 22 2019, 02:28 AM


Group: Member
Posts: 432

https://professionals.optumrx.com/content/d...019Q2_FINAL.pdf

QUOTE
This edition focuses on ten near-term pipeline drugs that are expected to receive a Food and Drug Adminstration (FDA)
approval decision by the end of the 3rd quarter of 2019. These drugs are notable because of their potential for clinical and/
or economic impact
. In many ways, they highlight an ongoing pipeline trend of focusing on Orphan Drug development and
conditions caused by genetic mutations.
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sharelooker
Posted on: May 21 2019, 03:36 AM


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Posts: 432

The presentation was today at 10:30 a.m.!
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sharelooker
Posted on: May 16 2019, 01:54 AM


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Posts: 432

I totally agree with you.! This could be a breakthrough technology! AVH also wants to focus on cell and gene therapy. So they can modify skin cells, e.g. to enhance collagen production which is the ultimate skin rejuvenation.
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sharelooker
Posted on: May 16 2019, 01:26 AM


Group: Member
Posts: 432

Maybe this technology can be used to treat feet and hands of vitiligo patients that generally don't response well to afamelanotide?!
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sharelooker
Posted on: May 13 2019, 05:37 PM


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Posts: 432

10 Year Anniversary:

https://www.youtube.com/watch?v=WtXYxUecHwQ
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sharelooker
Posted on: May 10 2019, 07:09 PM


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Posts: 432

AVH also focuses on skin rejuvenation (cosmetic) and is a debt-free company. I think PW likes that wink.gif. The CEO has an excellent background (Novartis etc.) and much expertise in gene and cell therapy. I think a merger of CUV and AVH would make a lot of sense regarding long term sustainability. Does BNYM plays a key role?

Corporate presentation:
https://www.asx.com.au/asxpdf/20190313/pdf/...g4hlc687m34.pdf
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sharelooker
Posted on: May 10 2019, 05:52 AM


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Posts: 432

Maybe Johnny H bought back his shares?!
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sharelooker
Posted on: May 8 2019, 05:39 AM


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Posts: 432

Global Healthcare Conference
Monday, May 20 – Wednesday, May 22
Grand Hyatt New York
New York City
Hosts: Rob DiGia and Dan Brennan

Three day conference bringing together investors and 200+ companies across the healthcare services and life sciences sectors for presentations as well as thematic panels, and concurrent one-on-one and group meetings

https://www.ubs.com/global/en/investment-ba...ence-agenda.pdf
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sharelooker
Posted on: May 7 2019, 08:49 PM


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Posts: 432

SCIENTIFIC COMMUNIQUÉ IV
https://www.clinuvel.com/photomedicine/scie...c-communique-iv

QUOTE
Not surprisingly, the work of CLINUVEL to provide systemic photoprotection is concentrated towards those individuals at highest risk (constitutional, familial) of contracting melanoma in their lifetime. The prevention of the disease in individuals at risk is an area of intense focus and critique by CLINUVEL’s teams, with the objective one day to have the ultimate preventative agent developed.
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sharelooker
Posted on: May 7 2019, 08:59 AM


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Posts: 432

It's Probably Overpriced!
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sharelooker
Posted on: May 2 2019, 06:45 PM


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Posts: 432

Maybe a hint that CUV ist currently negotiating with US health insurances?

http://provcomm.ibx.com/ProvComm/ProvComm....33;OpenDocument
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sharelooker
Posted on: May 2 2019, 09:42 AM


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Posts: 432

Newsletter is out!

https://www.asx.com.au/asxpdf/20190502/pdf/...sdwp551f27h.pdf
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sharelooker
Posted on: May 2 2019, 03:01 AM


Group: Member
Posts: 432

QUOTE
Afamelanotide for treating erythropoietic protoporphyria [ID927]: Following
receipt of an appeal, which was upheld at the appeal hearing on 30 July 2018,
the topic has been returned to the committee. Anticipated publication June 2019
(Q1 2019-20).


https://www.nice.org.uk/Media/Default/Get-i...rs-march-19.pdf
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sharelooker
Posted on: Apr 30 2019, 09:36 AM


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Posts: 432

Quarterly is out!

https://www.asx.com.au/asxpdf/20190430/pdf/...nn33nhvly80.pdf
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sharelooker
Posted on: Apr 26 2019, 06:49 PM


Group: Member
Posts: 432

https://youtu.be/a_UE-xNIDA4?t=548
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sharelooker
Posted on: Apr 20 2019, 03:33 AM


Group: Member
Posts: 432

This site has been updated recently:

https://www.clinuvel.com/clinuvel/company-o...tory-and-future

QUOTE
Our employees focus and specialise on key areas such as:
• the properties of visible light and ultraviolet light
• the interaction of visible light or UV light emitted and human biology in general
• behaviour of skin under extreme conditions
• the effect of hormonal therapies on anti-inflammatory and nervous disorders
• the release of pharmaceutical products in a controlled delivery
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sharelooker
Posted on: Apr 17 2019, 02:37 AM


Group: Member
Posts: 432

https://www.biopharmcatalyst.com/news/2019/...1eVI8KeBClLxd9w
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sharelooker
Posted on: Apr 16 2019, 02:46 AM


Group: Member
Posts: 432

https://www.asx.com.au/asxpdf/20190415/pdf/...b8s03vpfczm.pdf
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sharelooker
Posted on: Apr 15 2019, 03:36 AM


Group: Member
Posts: 432

I cannot believe that the interest in this company has hit an all time low, despite forthcoming FDA decision! They clearly need a lot of coverage in the US!


Google trends for 'clinuvel' in the US:
Attached image(s)
Attached Image

 
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sharelooker
Posted on: Apr 11 2019, 12:32 AM


Group: Member
Posts: 432

https://amazingerasmusmc.nl/actueel/vijf-mi...dagenlang-pijn/
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sharelooker
Posted on: Apr 10 2019, 04:55 AM


Group: Member
Posts: 432

Announcement of the new indication at the biocentury conference on friday?

QUOTE
CLINUVEL PHARMACEUTICALS LTD. (ASX:CUV; PINK:CLVLY)
ROOM - 404 / 405
PDUFA, photomedicines for orphan skin disorders


https://cms.biocentury.com/assets/images/co...dule_update.pdf
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sharelooker
Posted on: Apr 9 2019, 03:38 AM


Group: Member
Posts: 432

I think so! PW has emphasized this date in every newsletter since January.
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sharelooker
Posted on: Apr 8 2019, 07:28 AM


Group: Member
Posts: 432

https://www.bs-group-sa.com/wp-content/uplo...e-in-Lagaay.pdf

https://www.lagaay.com/
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sharelooker
Posted on: Apr 5 2019, 05:24 AM


Group: Member
Posts: 432

Great week so far! The next week will be very busy:

- 07-09: April London – HC Wainwright
- 08 April: FDA communication on labelling, post-marketing authorisation
- 12 April: New York – BioCentury Future Leaders
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sharelooker
Posted on: Apr 3 2019, 01:46 AM


Group: Member
Posts: 432

Restricting the google search results for 'afamelanotide' to the last 24 h, i get the following link. However, no information about 'afamelanotide' on this website.

https://www.fda.gov/advisorycommittees/whatsnew/default.htm

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sharelooker
Posted on: Apr 2 2019, 08:30 PM


Group: Member
Posts: 432

Schedule of the Biocentury conference is now online:

https://www.biocentury.com/conferences/future-leaders-2019

1:30 PM - 2:00 PM CLINUVEL PHARMACEUTICALS LTD. (ASX:CUV; PINK:CLVLY) ROOM - 404/405

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sharelooker
Posted on: Apr 2 2019, 05:08 AM


Group: Member
Posts: 432

I didn't get it either! First he said chance/risk ratio of 5:1, and then 10-12:1. I was confused about this part!
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sharelooker
Posted on: Apr 1 2019, 01:42 AM


Group: Member
Posts: 432

Summary:

- NYSE / NASDAQ listing very soon
- doesn't recommend selling the stock now
- discovered CUV at 3 mln now 1 bn (1,2 AUD -> 30 AUD)
- in 2-3 years: 10-30 bagger
- sees high potential in vitiligo (50 mln patients worldwide)
- compares CUV with Allergan
- skin cancer treatment
- additional 3 skin diseases
- expects massive cash flow in the next 40 years
- investors need patience
- has clients that made million of dollars with CUV
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sharelooker
Posted on: Apr 1 2019, 12:48 AM


Group: Member
Posts: 432

Nothing really new! He is very confident about a 30 bagger in the next 3 years.
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sharelooker
Posted on: Mar 31 2019, 07:52 PM


Group: Member
Posts: 432

https://www.youtube.com/watch?v=NFQpmLZ9huo&t=0s

28:10 min
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sharelooker
Posted on: Mar 29 2019, 07:33 AM


Group: Member
Posts: 432

https://www.asx.com.au/asxpdf/20190329/pdf/...w29jnhqj637.pdf

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sharelooker
Posted on: Mar 26 2019, 08:51 PM


Group: Member
Posts: 432

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://www.clinuvel.com/wp-content/uploads...al_Report-1.pdf
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sharelooker
Posted on: Mar 23 2019, 04:40 AM


Group: Member
Posts: 432

https://patents.google.com/patent/EP2673295...el&sort=new

QUOTE
2019-03-22
Application status is Withdrawn


https://patents.google.com/patent/US2013034...en&sort=new

QUOTE
2019-03-22
Application status is Abandoned


Bad news?
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sharelooker
Posted on: Mar 21 2019, 06:33 AM


Group: Member
Posts: 432

Website down!!!Password protected
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sharelooker
Posted on: Mar 20 2019, 07:00 AM


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Posts: 432

CLVLY has been recently added to the PDUFA calendar on BioPharmCatalyst. This will give us some more tailwind for the FDA run-up.

https://www.biopharmcatalyst.com/calendars/pdufa-calendar
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sharelooker
Posted on: Mar 20 2019, 02:18 AM


Group: Member
Posts: 432

http://www.aifa.gov.it/sites/default/files...na_SCENESSE.pdf
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sharelooker
Posted on: Mar 19 2019, 09:47 PM


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Posts: 432

I think they are flooded with inquiries from potential (US) investors and an Investor Form helps to structure these requests! I'm very happy to see their efforts to attract and care about new investors.
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sharelooker
Posted on: Mar 18 2019, 08:59 PM


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Posts: 432

BTW the new Acting FDA Commissioner was a co-founder of a biotech called Sapere Bio that focuses on cell-aging and senescence.
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sharelooker
Posted on: Mar 18 2019, 08:43 PM


Group: Member
Posts: 432

https://www.cash.ch/forum/boerse/aktien-aus...maceuticals-ltd

Good morning Mela

Thank you for your interest! But you have a lot of questions for an "unaffected" Wink

I'll try to answer one or two questions. In any case, I find it exciting that you have contacted us. I just write - don't be embarrassed to ask further questions. The questionnaire is a bit stupid. There are probably about 10 pages full of questions that I would formulate differently or even ask completely different. The questions are primarily about the current status of changes/improvements in dealing with EPP - so what has changed since the last implant. Dress habits, how did I expose myself to the sun/light, did I have EPP Schüber etc.? Duration approx. 30 minutes. Basically I think it's good that (whoever) wants to know what is changing. The total duration of the 'treatment' is about 1 hour. The implantation of the implant seems difficult to me - it needs experienced hands! The syringe goes under the skin, so that the medicine can spread best. It takes about 10 days until the whole substance is released. After only 3 days a tan is visible and the light protection is activated and becomes stronger and stronger - for about 2 months, then it decreases again. There are different strong EPP- characteristics. The stronger the more often an implant is necessary to be protected the whole year. For example, I only need 3 implants! I cannot judge the load for the evaluation of the questionnaires of an institute. I find the word "load" unsuitable - an implant costs about CHF 17'000.- and the institute/spital certainly earns it. At least once a year you have to give a blood sample and urine - these will be examined for changes because our liver is especially burdened with protoporphyrin. Also every year the skin has to be examined, especially with the treatment scenesse for skin cancer. NEW we EPPler go also to the sun... hihi... So process: Give blood, inject implant, give urine, fill out questionnaire.

The LIFE WITH scenesse is a NEW life - all EPPers confirm that to you. Pain is gone, shadow running is no longer necessary, social restrictions as well as professional are almost gone, sports are almost all possible...you can already imagine when a legless person suddenly gets 2 functioning legs or sees a blind person again? One should not underestimate EPP. The illness WITHOUT scenesse is very difficult to bear and needs much courage and willingness to suffer and perseverance. It has a massive impact on the EPPler!

Scenesse has massive potential - Cliunvel is also working on it. Skin cancer prevention, beauty industry and possible cell renewal (reduction of cell aging) are only the most important application areas of Clinuvel's drugs. There are more features by entering scenesse, but I don't want to declare them here because they are not official.

So that would be for now. As I said - just ask...

Dear greetings, star hour

Translated with www.DeepL.com/Translator
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sharelooker
Posted on: Mar 17 2019, 10:10 PM


Group: Member
Posts: 432

According to the latest BS's Investor Presentation, it seems that they are preparing their shareholders for a big leap into the health&beauty sector. With the acquisition of FragranceNet in October 2018, they now have a top online retailer in North America. I think it could serve as a distribution channel for CUV's skincare products.

https://www.bs-group-sa.com/wp-content/uplo...n-FY-2018-1.pdf

QUOTE
Online health & beauty is one of our main growth markets for coming years

FragranceNet
Integration well ahead of expectations; further improvements in margin expected
▪ Further focus on operational efficiency and roll out of business model outside US, with initial focus on
Europe and Australia


  Forum: By Share Code

sharelooker
Posted on: Mar 14 2019, 12:27 AM


Group: Member
Posts: 432

CLVLY $20.00!
  Forum: By Share Code

sharelooker
Posted on: Mar 13 2019, 08:53 PM


Group: Member
Posts: 432

Three Wise Monkeys Podcast
#17. Appen's acquisition, Advance NanoTek, Clinuval Pharmaceuticals and more!

CUV starts at 25:33 min
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sharelooker
Posted on: Mar 13 2019, 04:18 AM


Group: Member
Posts: 432

Research article by Sharpless about p53 and DNA repair:

https://www.cell.com/cell/fulltext/S0092-86...Fshowall%3Dtrue

https://endpts.com/ncis-ned-sharpless-to-ge...se-exit-report/
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sharelooker
Posted on: Mar 13 2019, 03:35 AM


Group: Member
Posts: 432

New FDA Commissioner is Norman Sharpless. He seems to be an expert in melanoma research.

https://link.springer.com/chapter/10.1007/9...-59259-994-3_15
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sharelooker
Posted on: Mar 10 2019, 12:17 AM


Group: Member
Posts: 432

Interesting posts from 'sternstunde' who is an EPP patient and has been treated with SC since five years.

https://www.cash.ch/forum/boerse/aktien-aus...maceuticals-ltd
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sharelooker
Posted on: Mar 2 2019, 05:11 AM


Group: Member
Posts: 432

Great report! Price target should be even higher because the planned OTC skincare products haven't been included in the report. Any guesses what happend to these products? In the December newsletter it was mentioned that they will be released in the "New Year".
  Forum: By Share Code

sharelooker
Posted on: Mar 1 2019, 11:07 PM


Group: Member
Posts: 432

http://www.more-ir.de/d/17623.pdf

New price target: AUD 58.40!
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sharelooker
Posted on: Feb 26 2019, 09:58 PM


Group: Member
Posts: 432

Someone is grabbing shares like an insane! Total amount was 173k (asx + chix). New substantial owner? Take-over?
  Forum: By Share Code

sharelooker
Posted on: Feb 26 2019, 09:49 AM


Group: Member
Posts: 432

Half-year report is out:
https://www.asx.com.au/asxpdf/20190226/pdf/...z7l8z6wq5mv.pdf
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sharelooker
Posted on: Feb 25 2019, 06:52 PM


Group: Member
Posts: 432

Combined ASX and CHI-X volume was 130k! Strong accumulation is still ongoing.
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sharelooker
Posted on: Feb 19 2019, 12:39 AM


Group: Member
Posts: 432

QUOTE
Some patients themselves, however, still had their grievances. The conference saw emotive testimony from the International Porphyria Patient Network’s Rocco Falchetto, who recounted his and others’ experiences with erythropoietic protoporphyria (EPP), a rare and debilitating and antisocial disease that causes acute photosensitivity of the skin. Falchetto’s group was one of a number of bodies that lodged appeals against a decision by NICE’s Highly Specialized Technologies committee to maintain its December 2017 recommendation that Clinuvel’s EPP drug Scenesse (afamelanotide) should not be funded under the NHS for treating patients with the condition. Both EMA and NICE, said Falchetto, have failed to acknowledge the evidence provided in patient testimonies and by expert physicians “on the overwhelming clinical benefit” of Scenesse. “If you involve patients early,” Falchetto told the audience, “it does not have to come to an appeal—as in our case. Take us seriously!”


http://www.pharmexec.com/dia-europe-patien...say-now-doctors
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sharelooker
Posted on: Feb 15 2019, 03:09 AM


Group: Member
Posts: 432

All Time High for CLVLY: $16.70!
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sharelooker
Posted on: Feb 14 2019, 08:36 PM


Group: Member
Posts: 432

Does anyone know what this means?

Bold and Italics : Indicates Bonus stocks (LVR is applicable for diversified portfolios)

https://www.commsecadviserservices.com.au/m...-securities.pdf
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sharelooker
Posted on: Feb 14 2019, 05:15 AM


Group: Member
Posts: 432

They don't have the PLGA-polymer technology.
  Forum: By Share Code

sharelooker
Posted on: Feb 14 2019, 02:11 AM


Group: Member
Posts: 432

https://www.cv-library.co.uk/job/209494844/...72-6991cdba2b6e

https://www.randstad.com.sg/jobs/formulatio...apore_16345943/

https://www.randstad.com.sg/jobs/laboratory...apore_16491765/
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sharelooker
Posted on: Feb 13 2019, 11:55 PM


Group: Member
Posts: 432

https://www.fda.gov/NewsEvents/Newsroom/Pre...s/ucm630942.htm
  Forum: By Share Code

sharelooker
Posted on: Feb 13 2019, 08:17 PM


Group: Member
Posts: 432

This case shows the openness of the FDA to disruptive drugs like esketamine despite missed primary endpoints.

https://endpts.com/fda-experts-offer-a-big-...-spur-concerns/

QUOTE
If the FDA goes ahead and offers a formal approval, which looks increasingly likely in view of the neutral internal review, they’ll be once again overlooking the agency’s gold standard on 2 positive, well controlled studies. But that’s increasingly common, especially under commissioner Scott Gottlieb.
  Forum: By Share Code

sharelooker
Posted on: Feb 11 2019, 11:14 PM


Group: Member
Posts: 432

Quite big difference in volumes:

https://www.clinuvel.com/investors/share-prices ->108k


https://www.asx.com.au/asx/share-price-research/company/CUV ->50k

Special trade arrangements?


  Forum: By Share Code

sharelooker
Posted on: Feb 10 2019, 07:00 AM


Group: Member
Posts: 432

https://www.policlinico.mi.it/uploads/fom/a...ta_scenesse.pdf
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sharelooker
Posted on: Feb 8 2019, 12:32 AM


Group: Member
Posts: 432

A great newsletter! I also like the mention of a new financial reporting system. Obviously they are expecting massive cash inflows in future or they need a new system as a requirement for NASDAQ listing.

  Forum: By Share Code

sharelooker
Posted on: Feb 8 2019, 12:32 AM


Group: Member
Posts: 432

A great newsletter! I also like the mention of a new financial reporting system. Obviously they are expecting massive cash inflows in future or they need a new system as a requirement for NASDAQ listing.

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sharelooker
Posted on: Feb 7 2019, 10:47 AM


Group: Member
Posts: 432

https://www.solocheck.ie/Irish-Company/Clin...-Limited-638236
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sharelooker
Posted on: Feb 1 2019, 11:48 PM


Group: Member
Posts: 432

ASX 200 List (1 February 2019)

https://www.asx200list.com/
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sharelooker
Posted on: Feb 1 2019, 10:03 PM


Group: Member
Posts: 432

Excellent summary!
+ an expansion of the company through acquisition with positive cash flow post-acquisition. This was also part of the CFOs long-term incentive plan and must be achieved before 30 June 2019.
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sharelooker
Posted on: Feb 1 2019, 03:17 AM


Group: Member
Posts: 432

QUOTE
Public Response to NoMA Assessment Report –
CLINUVEL (UK) LTD


pp. 96 - 101

https://nyemetoder.no/Documents/Beslutninge...g%20versjon.pdf
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sharelooker
Posted on: Jan 23 2019, 05:26 AM


Group: Member
Posts: 432

I like the new design of the drop down navigation menu! It looks more professional.

https://www.clinuvel.com/





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sharelooker
Posted on: Jan 21 2019, 11:00 PM


Group: Member
Posts: 432

What's your estimate for the quarterly results next week?
My guess: AUD 7.5 - 8.5M in receipts.
  Forum: By Share Code

sharelooker
Posted on: Jan 20 2019, 03:13 AM


Group: Member
Posts: 432

Could it be that BB Biotech, a Swiss investment company, accumulates CUV shares for its portfolio? When i restrict my search results for "clinvuel" to the last 24 h, google puts out the link to the portfolio site!
The company invested in CUV in 2009, however sold its stake in 2010.

https://en.wikipedia.org/wiki/BB_Biotech

https://www.bbbiotech.ch/de/bb-biotech/stra...olio/portfolio/


  Forum: By Share Code

sharelooker
Posted on: Jan 18 2019, 01:14 AM


Group: Member
Posts: 432

QUOTE
6 Implantate sind für die meisten Patienten wichtig, um einen dauerhaften
Schutz aufzubauen. An anderen Kliniken wird dies auf ärztlichen Rat umgesetzt, die
Krankenkassen sehen darin keine Probleme


Translation::

QUOTE
6 Implants are important for most patients in order to achieve a permanent
protection. At other clinics, this is implemented on the advice of doctors, who
Health insurance companies see no problems in it.


It seems, that some german doctors already prescribe six implants per year!
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sharelooker
Posted on: Jan 15 2019, 11:11 PM


Group: Member
Posts: 432

According to the recent newsletter, PW is well aware of Mitsubishi's new oral melanocortin drug and it seems to be effective. Some EPP patients have been very enthusiastic about the outcome. I think the company is now planning a phase 3 study?! Does anyone know if the FDA instructed CUV/Epitan to formulate the drug as an implant in order to get it through the regulatory process? Then, why is Mitsubishi pursuing an oral drug for the treatment of EPP?
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sharelooker
Posted on: Jan 10 2019, 09:31 AM


Group: Member
Posts: 432

QUOTE
Priority Review granted for innovative drug, PDUFA date 8 July 2019


https://www.asx.com.au/asxpdf/20190110/pdf/...sc3v3tm7xs5.pdf
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sharelooker
Posted on: Jan 9 2019, 07:35 AM


Group: Member
Posts: 432

https://www.statnews.com/2019/01/07/fda-pla...g-edge-science/
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sharelooker
Posted on: Jan 8 2019, 03:19 AM


Group: Member
Posts: 432

Bad news!

https://nyemetoder.no/Documents/Rapporter/A...devurdering.pdf

QUOTE
NoMA’s overall appraisal
The limited clinical documentation indicates that treatment with afamelanotide has a small effect on
duration of exposure to sunlight. However, it has not been possible to establish whether the treatment
improves the quality of life. The severity calculations are also subject to high uncertainty.
The Market Authorisation Holder and the clinician NoMA has been in contact with, suggest that the
treatment with afamelanotide may have benefits that are not easily demonstrated in clinical trials. They
are referring to long term adherence to the treatment in compassionate use and expanded access
programmes. Reference to adherence in these programmes is not sufficient to estimate an effect size of
the treatment. Therefore, it is not possible for NoMA to assess the potential benefits the patients could
acquire with afamelanotide.
NoMA does not consider that cost effectiveness is documented for afamelanotide.
  Forum: By Share Code

sharelooker
Posted on: Dec 25 2018, 01:46 AM


Group: Member
Posts: 432

Acorda received a RTF letter for INBRIJA on 08/29/2017 due to manufacturing issues:

http://ir.acorda.com/investors/investor-ne...on/default.aspx

They resubmitted the NDA on 12/07/2017:

http://ir.acorda.com/investors/investor-ne...er/default.aspx

NDA was then accepted on 02/20/2018:

http://ir.acorda.com/investors/investor-ne...er/default.aspx

..and INBRIJA was finally approved on 12/21/2018 as the 60th FDA approval in 2018!

http://ir.acorda.com/investors/investor-ne...er/default.aspx

Assuming that CUV has resubmitted the additional information at the beginning of November 2018, we should have the FDA feedback until mid of January 2019

Merry Christmas to all of you!
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sharelooker
Posted on: Dec 23 2018, 02:26 AM


Group: Member
Posts: 432

During CUV's series "12DaysofSkin", three diseases have been addressed so far: EPP, Vitiligo and XP. It's most likely that XP will be the third indication and i'm expecting an official announcement in the next 1-2 weeks. Update your models!

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sharelooker
Posted on: Dec 14 2018, 11:12 PM


Group: Member
Posts: 432

The advisory committee meeting was already mentioned in the March newsletter and it's quite common for a NME like SC. So i don't think it's gonna have much impact on the length of the review process.
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sharelooker
Posted on: Dec 13 2018, 06:08 AM


Group: Member
Posts: 432

https://www.fda.gov/downloads/AboutFDA/Cent...R/UCM628150.pdf
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sharelooker
Posted on: Dec 13 2018, 05:24 AM


Group: Member
Posts: 432

I'm pretty certain that the recent NDA delay is due to the new implementations of the FDA regarding RWE and GMP.

https://www.fda.gov/NewsEvents/Newsroom/Pre...s/ucm628244.htm
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sharelooker
Posted on: Dec 12 2018, 07:57 AM


Group: Member
Posts: 432

Newsletter is out:

https://www.asx.com.au/asxpdf/20181212/pdf/...4szm77yczfm.pdf

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sharelooker
Posted on: Dec 9 2018, 08:04 PM


Group: Member
Posts: 432

Belgium

https://www.afmps.be/sites/default/files/co...nt/bt_afmps.pdf
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sharelooker
Posted on: Dec 9 2018, 05:48 AM


Group: Member
Posts: 432

I dont't know if this has been posted before:

QUOTE
Explained simply: Refuse-to-file actions allow FDA to inform a sponsor as quickly as possible of deficiencies in an NDA or BLA, helping companies to correct such issues rather than wait for FDA to issue a complete response letter.

Incomplete applications, including applications for which minor components have not been received within 30 calendar days after receipt of the original application, as may have been agreed upon at a pre-submission meeting, may also be refused for filing, the agency explains.


https://www.raps.org/regulatory-focus%E2%84...idance-explains

Maybe the GMP inspection was under way during the 2-month NDA validation period and they knew that the need to hand in the results of the manufacturing process later. This would be consistent with Stan's statement that they've expected the FDA's requests.
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sharelooker
Posted on: Dec 9 2018, 05:05 AM


Group: Member
Posts: 432

https://trademarks.justia.com/search?q=clinuvel
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sharelooker
Posted on: Dec 7 2018, 04:33 AM


Group: Member
Posts: 432

Mandarine Gestion SA

https://www.barrons.com/quote/stock/au/xasx/cuv
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sharelooker
Posted on: Dec 7 2018, 04:21 AM


Group: Member
Posts: 432

More about the new program:

https://www.fda.gov/downloads/ScienceResear...e/UCM627769.pdf
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sharelooker
Posted on: Dec 7 2018, 04:02 AM


Group: Member
Posts: 432

The official statement:

https://www.fda.gov/NewsEvents/Newsroom/Pre...s/ucm627760.htm
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sharelooker
Posted on: Dec 7 2018, 03:10 AM


Group: Member
Posts: 432

QUOTE
The US Food and Drug Administration (FDA) on Thursday unveiled a new framework discussing how the agency will use real world evidence (RWE) and real-world data (RWD) to help companies win new indications for approved drugs and biologics, expand labels or satisfy post-approval study requirements.

As far as what the framework will guide FDA on specifically, the agency said its RWE program will evaluate the potential use of RWE to support changes to labeling about drug product effectiveness, including adding or modifying an indication, such as a change in dose, dose regimen or route of administration; new populations; or the addition of comparative effectiveness or safety information.


https://www.raps.org/news-and-articles/news...s-to-support-ef
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sharelooker
Posted on: Dec 1 2018, 05:26 AM


Group: Member
Posts: 432

FCS Asset Management Ltd. (Spain)

https://www.barrons.com/quote/stock/au/xasx/cuv
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sharelooker
Posted on: Nov 28 2018, 06:45 AM


Group: Member
Posts: 432

Just updated!

https://www.nice.org.uk/guidance/indevelopment/gid-hst10009

Committee meeting 3: 14 March 2019
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sharelooker
Posted on: Nov 28 2018, 05:54 AM


Group: Member
Posts: 432

QUOTE
Afamelanotide has a promising future as a treatment for a variety of skin diseases including EPP, solar urticaria, PMLE, acne vulgaris, vitiligo and Hailey-Hailey disease. In consideration of the limited data available on afamelanotide use in children, elderly patients, pregnant or lactating women, and those with hepatic or renal impairment, more studies are needed to evaluate safety and efficacy in these populations.5 The anti-inflammatory, pigmenting and free radical scavenging effects produced by the stimulation of melanin production, coupled with a mild side effect profile, make afamelanotide an attractive and versatile compound that shows therapeutic potential in a variety of dermatologic conditions.


http://www.skintherapyletter.com/dermatology/afamelanotide/
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sharelooker
Posted on: Nov 25 2018, 08:37 PM


Group: Member
Posts: 432

Interesting publications regarding the reimbursement processes in europe:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5491965/

https://reader.elsevier.com/reader/sd/pii/S...55DED00FA79E29A

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sharelooker
Posted on: Nov 25 2018, 01:26 AM


Group: Member
Posts: 432

QUOTE
- Erythropoietic protoporphyria: The Scenesse, a symptomatic treatment for Erythropoietic Protoporphyria, is still not available or reimbursed in France, but the Clinuvel company that markets it has finally started the reimbursement request to the health authorities. Our center gives all its support to advance in their efforts.


https://www.porphyrie.net/action-et-soutien/
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sharelooker
Posted on: Nov 24 2018, 07:46 AM


Group: Member
Posts: 432

QUOTE
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen and modernize agency’s oversight and reporting of inspections for sterile injectable drugs


https://www.fda.gov/NewsEvents/Newsroom/Pre...s/ucm625601.htm

Maybe this could be the cause for the recent delay?!
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sharelooker
Posted on: Nov 24 2018, 03:09 AM


Group: Member
Posts: 432

23 November 2018

QUOTE
To date, what are the therapeutic options?

"An innovative drug is currently available, called afamelanotide [which is the subject of a recent parliamentary question , Ed], which is implanted under the skin at the iliac crest, after local anesthesia. It is a powerful antioxidant, which does not cure the underlying disease but significantly mitigates phototoxic reactions. The circulating levels of protoporphyrin remain therefore high, but the patient increases his tolerance to sun exposure, thus managing to perform outdoor activities that were previously impossible. Studies are currently being carried out on the safety and efficacy of pediatric afamelanotideIn fact, to date, the drug is authorized only in adults. Alternatively, it is possible to prescribe UV-ray filtering creams , however of low efficacy, and antioxidant supplements . Other isolated experiences on the use of zinc sulphate, cimetidine in pediatric age and UVB phototherapy are published in the literature ".


https://www.osservatoriomalattierare.it/por...l-sole-fa-paura
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sharelooker
Posted on: Nov 15 2018, 04:57 PM


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Posts: 432

https://www.osservatoriomalattierare.it/por...o-la-burocrazia
  Forum: By Share Code

sharelooker
Posted on: Nov 13 2018, 07:54 PM


Group: Member
Posts: 432

Is there a possibility to watch this interview online?
  Forum: By Share Code

sharelooker
Posted on: Nov 8 2018, 02:09 AM


Group: Member
Posts: 432

Interesting! A medical doctor in Canada.

QUOTE
Certifications
Certification for the administration of Scenesse (afamelanotide)- Clinuvel


https://my.clevelandclinic.org/canada/staff/champagne-trevor
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sharelooker
Posted on: Nov 5 2018, 09:19 PM


Group: Member
Posts: 432

Mr. Max Otte's fund is now holding 36k shares.

QUOTE
Privatinvestor Verwaltungs AG


https://www.barrons.com/quote/stock/au/xasx/cuv?mod=DNH_S
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sharelooker
Posted on: Nov 1 2018, 07:07 PM


Group: Member
Posts: 432

6.) November 10, Häm O'Globin and Family: Therapy of a rare light disease in Zürich
https://www.kispi-150.ch/forschungstage-im-...ahnhof-zuerich/
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sharelooker
Posted on: Oct 31 2018, 09:17 PM


Group: Member
Posts: 432

31 October 2018

QUOTE
Rome - The procedures for obtaining the drug afamelanotide, essential for patients affected by erythropoietic protoporphyria , are too complex: now a question presented to the Senate asks the Minister of Health Giulia Grillo which initiatives she intends to take to streamline them. The text, presented last October 24 by the senators Paola Binetti (president of the Rare Disease Parliamentary Intergroup) and Maria Rizzotti , suggests a possible intervention at the European Medicines Agency (EMA) in order to facilitate access to therapy throughout Europe .


QUOTE
The difficulties for access to therapy come from the reserves of the EMA , which in 2014 published the report EMA / CHMP / 601433/2014 , raising a series of concerns, especially on the time of effectiveness of the drug , reducing it to a handful of minutes .


QUOTE
Senators Binetti and Rizzotti , in the written answer to question no. 4-00736, then asked the Minister what initiatives he intends to take to streamline procedures and facilitate access to the drug for patients who need it: "rare patients", but who are in extreme need of the medicine. It also asks if the Minister does not consider intervening at the EMA to request a review of his report, so as to facilitate access to the drug throughout Europe, also on the basis of data collected in Italy, which confirm its effectiveness and security.


https://www.osservatoriomalattierare.it/por...l-afamelanotide
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sharelooker
Posted on: Oct 30 2018, 03:33 AM


Group: Member
Posts: 432

5.) November 24, First Meeting Doctors Porfiria Patients in Rome
https://www.osservatoriomalattierare.it/app...zienti-porfiria



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sharelooker
Posted on: Oct 29 2018, 08:32 PM


Group: Member
Posts: 432

https://www.finnewsnetwork.com.au/archives/...work201065.html
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sharelooker
Posted on: Oct 28 2018, 07:18 PM


Group: Member
Posts: 432

A lot of conferences and meetings in November:

1.) November 6, World Orphan Drug Congress 2018 in Barcelona
https://www.terrapinn.com/conference/world-...genda-day-1.stm

2.) November 13, Bio Connections Australia Conference in Melbourne
https://www.informa.com.au/event/conference...ions-australia/

3.) November 17, German EPP Patient Meeting in Hamburg
http://www.epp-deutschland.de/

4.) November 21, CUV AGM Meeting in Melbourne
https://www.clinuvel.com/investors/news/ite...nfirms-agm-date

I've never seen such a packed schedule.

+ possible regulatory outcomes from NICE and FDA
+ possible announcements of the new indication and skincare products. Hopefully, they'll be ready soon. So they can catch the Christmas trade.
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sharelooker
Posted on: Oct 24 2018, 01:23 AM


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Posts: 432

Johnson & Johnson Announces Offer to Acquire Ci:z Holdings Co., Ltd.
Acquisition is Expected to Expand J&J's Consumer Portfolio of Science-based Dermocosmetic Beauty Products

http://www.investor.jnj.com/releasedetail....leaseID=1079631

QUOTE
"Health and beauty consumers are actively seeking science-based innovation to improve their skin," said Jorge Mesquita, Worldwide Chairman, Johnson & Johnson Consumer. "This transaction will maximise value creation for Johnson & Johnson's Consumer business by bringing in an agile innovation model and rapidly accelerating sales through our global commercialization expertise."
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sharelooker
Posted on: Oct 21 2018, 10:32 PM


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Posts: 432

only in german:

http://www.epp-deutschland.de/mediapool/21...ata/FR7_EPP.PDF
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sharelooker
Posted on: Oct 20 2018, 08:00 AM


Group: Member
Posts: 432

Farma, I agree with you! Moreover, if they prove that SC can enhance the repair mechanism of UV-damaged DNA in XP, CUV will have the ultimate proof that SC can be used to prevent skin cancer in (healthy) fair-skinned people.
  Forum: By Share Code

sharelooker
Posted on: Oct 20 2018, 02:21 AM


Group: Member
Posts: 432

PAD, why don't you think it's XP? They often stated that the new indication would involve "DNA-repair" which perfectly fits for XP. And they said:
QUOTE
...starting to evaluate SCENESSE® in patients with a genetic affliction.
. HHD wouldn't be a start since there has already been studies with SC.
  Forum: By Share Code

sharelooker
Posted on: Oct 19 2018, 07:29 PM


Group: Member
Posts: 432

Wow, this is brilliant! Have they ever talked about an investor relations team before?! Let's see, if they reply to emails now!
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sharelooker
Posted on: Oct 19 2018, 06:02 PM


Group: Member
Posts: 432

OTC products seem to be ready!

QUOTE
We all share the excitement about the potential clinical – and therefore commercial – value we could create from these follow-on prescriptive and complementary OTC products coming out of Singapore. We carefully position these chronologically so as to make sure that each pharmaceutical product addresses an unmet clinical need or a genuine demand for non-prescriptive products. Although regulatory requirements are less stringent for over the counter (OTC) products, we are working towards market launch once our teams have fulfilled all legal, regulatory and commercial requirements. These OTC product lines will need to provide more prominence to the CLINUVEL brand, and position us further as specialists in photomedicine while we enter defined channels to distribute our non-prescriptive products.
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sharelooker
Posted on: Oct 19 2018, 05:23 PM


Group: Member
Posts: 432

I dont't think the indication will be HHD!

They stated:
QUOTE
..starting to evaluate SCENESSE® in patients with a genetic affliction.

SC has already been studied in a phase 2 HHD trial. Five years of preparation work indicates that the new inidication must be very complex.
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sharelooker
Posted on: Oct 19 2018, 03:47 PM


Group: Member
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What could be the 3rd indication? I would bet on XP and you?
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sharelooker
Posted on: Oct 19 2018, 02:59 AM


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http://www.brickcourt.co.uk/news/detail/ni...ccessful-appeal
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sharelooker
Posted on: Oct 18 2018, 10:57 PM


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Posts: 432

https://www.ncbi.nlm.nih.gov/pubmed/16396514

QUOTE
Should these trends be validated in humans, alpha-MSH-based therapeutics specifically active in the CNS or peripheral circulation may be promising for the treatment of type 2 diabetes.


https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5034615/

QUOTE
These data describe a novel endocrine circuit that modulates glucose homeostasis by pituitary α-MSH, which increases muscle glucose uptake and thermogenesis through the activation of a MC5R-PKA-pathway, which is disrupted in obesity.


https://pdfs.semanticscholar.org/f3f2/5a771...e70cf80b791.pdf

QUOTE
We conclude that MSH improves global heart functions in ZDF rats, but these effects are not related to the vascular status
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sharelooker
Posted on: Oct 18 2018, 10:06 PM


Group: Member
Posts: 432

Ok, let's sum it up! PW is now preparing the company for the long run and long term stability. With WB, he has an expert for distribution and logistics, with Mr. Luger from Münster he has an expert for MS and other inflammatory diseases and with Ms. Agersborg he has an expert in the field of diabetes (there is plenty of research that alpha-MSH could be effective in type 2 diabetes).

All this reminds me of the movie Independance Day when the mothership from space coordinated its smaller ships around the globe. And then, when the final countdown was over:.....BAAANG! This is probably the end game!
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sharelooker
Posted on: Oct 18 2018, 05:46 PM


Group: Member
Posts: 432

QUOTE
Hence, this compound
(Scenesse®) might represent a perfect possibility for drug repurposing.
Scenesse®, based on our in vitro data and the observations
made in mice models (Mykicki et al., 2016), could be an interesting and
promising target for further clinical development in MS therapy. Thus,
the characterization of the external factor UVB light as potent immunomodulator
in MS (Breuer et al., 2014) and the identification of a
possible mechanism by which external signals might be transmitted
into susceptible organisms (Mykicki et al., 2016) followed by the
identification of approved drugs that could be repurposed (Scenesse®)
might represent an innovative concept of using environment mimetics
for the development of novel MS therapeutics.


Breuer, J., Loser, K., Mykicki, N., Wiendl, H., & Schwab, N. (2018). Does the environment influence multiple sclerosis pathogenesis via UVB light and/or induction of vitamin D?. Journal of Neuroimmunology.

https://www.sciencedirect.com/science/artic...165572817304782
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sharelooker
Posted on: Oct 17 2018, 10:14 PM


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Posts: 432

I think we'll hear something about the the FDA process next week which is exactly two month after the initial feedback on 22th August.
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sharelooker
Posted on: Oct 17 2018, 05:38 AM


Group: Member
Posts: 432

Very impressive lecture from Mr. Luger from the University of Münster about the anti-inflammatory and neuroprotective effects of afamelanotide. They've found many surprising effects that haven't been published yet. I really hope, that CUV is going after these indications! Unfortunately, it's only in german language.

http://www.medroom.at/p.php?action=vortrag...2061&PREV=0
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sharelooker
Posted on: Oct 16 2018, 10:32 PM


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Posts: 432

Max Otte, a well-known german fund manager, has accumulated CUV shares for his "Multiple Opportunities Fund". He is a fan of the Buffett-strategy ("buy and hold").

https://www.privatinvestor.li/wp-content/up...10/momo18Q3.pdf (only in german language)

QUOTE
Positioning, acquisitions and sales
In the last quarter, we have, among other things
with the Australian Clinuvel Pharmaceuticals,
the American shoe manufacturer Skechers and
United Internet (WEB-Mail, 1&1) strengthened. Clinuvel
is the only pharmaceutical company that can offer a
drug against the rare, genetically caused
light intolerance disorder EPP has. The sufferers
have to be constantly shielded in the dark
in Europe will gradually become treatment centres. In Europe, treatment centres are gradually becoming
In the USA, the In the USA, the
Admission applied for a few weeks ago. The patients
have reported great progress in
a rate of re-treatment of well over 90%.
Since our purchase, the price has been calculated in EUR.
96.6% up at the end of the quarter.

Translated with www.DeepL.com/Translator


https://en.wikipedia.org/wiki/Max_Otte
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sharelooker
Posted on: Oct 13 2018, 08:03 PM


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Posts: 432

Thanks for posting!
I really like this interview! I've a gut feeling that PW is very optimistic about a positive outcome of the process. Was there ever been a similar case where a pharma company sued the NICE?
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sharelooker
Posted on: Oct 13 2018, 06:34 PM


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Does anybody have access to the article? Is it useful?
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sharelooker
Posted on: Oct 13 2018, 08:17 AM


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UK Appeal Panel Tells NICE To Revisit Scenesse Rejection

https://pink.pharmaintelligence.informa.com...nesse-Rejection
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sharelooker
Posted on: Oct 12 2018, 03:48 AM


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Posts: 432

Interesting discussion here!

My thoughts: There is a lot of restructuring work going on at the FDA at the moment. Trump/Gottlieb want to modernize the FDA regarding drug reviews/approvals. So it can be that the SC review falls into a new process route where we still don't know the details. Remember that CUV is very open for new routes (patient input at the EMA, Real World Data for FDA etc.).

https://endpts.com/reorganization-of-ond-to...-woodcock-says/
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sharelooker
Posted on: Oct 6 2018, 03:36 AM


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Posts: 432

QUOTE
The CLINUVEL team are looking forward to presenting at the annual #BPA conference held at #Reading tomorrow.

Find out more by following the link below!

http://www.porphyria.org.uk/?event=2018-au...-conference-agm

In the past, they've never posted such events on their fb page. Maybe, they'll announce something important about the NICE process?!
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sharelooker
Posted on: Sep 23 2018, 06:05 AM


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The two sites https://www.clinuvel.com/Categories/pharmac...rch-development and https://www.clinuvel.com/Categories/pharmaceuticals/pipeline are currently not accessible (error 404).

I think they are updating the pipeline bar chart with the new indication! Very exciting!
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sharelooker
Posted on: Sep 16 2018, 03:12 AM


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Posts: 432

CUV is already in their portfolio with 0.00018% of net assets! Check out 'Holding details'!

https://www.vanguardinvestments.com.au/reta...8205/?portfolio
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sharelooker
Posted on: Sep 2 2018, 10:21 PM


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Posts: 432

A nicely updated profile of CUV on barrons smile.gif

https://www.barrons.com/quote/stock/au/xasx/cuv
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sharelooker
Posted on: Sep 2 2018, 06:33 PM


Group: Member
Posts: 432

QUOTE
NewsMakers is the best opportunity — in a single day — for the investment and pharma business development communities to evaluate investment and licensing opportunities.


QUOTE
NewsMakers presents a hand-picked group of public biotech companies whose corporate and regulatory milestones will drive stock prices. NewsMakers is recognized as the industry's key venue for companies to take their story to Wall Street each Fall. Thus, NewsMakers remains the best opportunity for business development executives and key members of the institutional investment and analyst communities to compare notes and assess the industry landscape.

Last year, more than 500 delegates congregated at NewsMakers, including money managers who controlled more than $600 billion in equity assets, with over $50 billion dedicated to healthcare and $15 billion dedicated to biotech.


QUOTE
The 25th Annual
NEWSMAKERS IN THE BIOTECH INDUSTRY
Friday, September 7, 2018 • Millennium Broadway Hotel • 145 West 44th Street • New York City
Presented by BIOCENTURY

Clinuvel Pharmaceuticals Ltd.
(ASX:CUV; Pink:CLVLY)
Breakout Room - 301 (9:30 - 10:00)


https://www.biocentury.com/conferences

https://www.biocentury.com/conferences/newsmakers-2018

https://www.biocentury.com/sites/default/fi...M18schedule.pdf
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sharelooker
Posted on: Sep 2 2018, 03:46 AM


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Posts: 432

Interesting! B&S acquired a majority stake in an online discount US retailer. Maybe relevant for the roll-out of the skincare products in the future?

QUOTE
FragranceNet.com’s proprietary technology enables B&S Group to strengthen the Group’s
sourcing network, buying power and assortment in its Health & Beauty category. The acquisition
allows B&S Group to generate a substantial footprint in North America for its Health & Beauty
category
and to roll out FragranceNet.com’s business model to other geographical areas.


https://www.bs-group-sa.com/wp-content/uplo...ragranceNet.pdf
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sharelooker
Posted on: Aug 31 2018, 05:16 AM


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Posts: 432

Now, all trademarks are registered!

https://www.trademarkia.com/ctm/ctm-company...810201-page-1-2
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sharelooker
Posted on: Aug 31 2018, 05:07 AM


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Posts: 432

https://www.clinuvel.com/pharmaceuticals/pipeline
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sharelooker
Posted on: Aug 25 2018, 10:10 PM


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Posts: 432

I agree with mrdax. Please do not read on the german board. It's full of crap, nonsense, stupidity and misleading information.
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sharelooker
Posted on: Aug 12 2018, 12:33 AM


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Posts: 432

Did they change the design of the barchart of their pipeline products?

https://www.clinuvel.com/pharmaceuticals/pi...rch-development
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sharelooker
Posted on: Aug 11 2018, 08:28 PM


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Posts: 432

From the patent:

QUOTE
Despite the high level of DNA damage occurring in XP patients, we realized that XP patients have remaining -low or very low- DNA repair capability. We further realized that such residual activity however means that the complexes and pathways in XP patients are at least partially intact. Based on these insights and despite the XP protein in XP patients having a different structure with associated dysfunctionality, we realized not only that these different XP proteins are still being recruited for complexes used in the DNA repair pathways, but also -importantly- that administration of MCIR agonists according to the invention to XP patients further enhances such recruitment of factors -including the different XP protein- for these complexes. Further, we realized that alpha-MSH analogues of the invention, as MCIR agonists, often better associate with various allele variants of the MCIR receptor associated with DNA repair in comparison with natural alpha-MSH levels, rendering the subsequent factor recruitment and DNA repair in XP patients more effective. We also realized that exposure of XP patient to alpha-MSH analogue compounds over longer periods enhances factor recruitment and subsequent DNA repair even further. We conclude that use of alpha-MSH analogue compounds of the invention in XP patients leads to an improved DNA repair capability reducing the cancer risk for XP patients particularly when compared to alpha-MSH at natural levels.


https://patentscope.wipo.int/search/de/deta...Id=WO2018142318

And it's not only the DNA-repair mechanism, that can reduce the incident of melanoma in XP patients but also the melanin enhancing effect of alpha-MSH. In my opinion, both mechanisms can result in a synergistic effect.
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sharelooker
Posted on: Aug 11 2018, 02:20 AM


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Posts: 432

Now, it's official. They aim at XP! It's a brand new patent!

https://patentscope.wipo.int/search/en/search.jsf

https://worldwide.espacenet.com/publication...KC=A1&ND=5#

https://register.epo.org/ipfwretrieve?apn=I...29.W&lng=en

QUOTE
WO/2018/142318 ALPHA-MSH ANALOGUES USED IN THE TREATMENT OF XERODERMA PIGMENTOSUM

The present invention relates to alpha-MSH analogue compounds for treatment of Xeroderma Pigmentosum (XP), specifically for repairing DNA in a subject suffering from XP.

Attached thumbnail(s)
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sharelooker
Posted on: Jul 28 2018, 08:03 PM


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Posts: 432

I think, we won't see an APPENDIX 4C ever again! I've tracked this for the australian company "Nanosonics" (ASX: NAN). After the fourth consecutive CF positive statement on 16/01/2017, they've never issued it again.
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sharelooker
Posted on: Jul 5 2018, 01:30 AM


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Posts: 432

http://www.clinuvel.com/social-media/subq/asx-listed

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sharelooker
Posted on: Jul 3 2018, 08:03 AM


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Posts: 432

https://www.fidelity.com.hk/static/pdf/inve...ance_report.pdf

Page: 103. CUV on a TOP 10 list together with tencent, alibaba and softbank smile.gif
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sharelooker
Posted on: Jun 28 2018, 03:58 AM


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Posts: 432

https://pink.pharmaintelligence.informa.com...nce-From-Europe

You can register for a free trial and read the article
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sharelooker
Posted on: Jun 28 2018, 01:01 AM


Group: Member
Posts: 432

9 - 11 mln!
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sharelooker
Posted on: Jun 26 2018, 11:11 PM


Group: Member
Posts: 432

From APF on facebook:

QUOTE
URGENT We are friends and care about each other. Our EPP friends desperately need SCENESSE, an EPP treatment that is revolutionary. It is at the FDA now for their review for approval. PLEASE , please take a few minutes of your life and write a letter. Remember , our EPP friends can only have a few minutes in the light before they are in searing pain. Scenesse prevents this. We need the FDA to give the drug PRIORITY REVIEW . Finally, we have a chance for approval. Even if you don't have EPP, you can help by writing a letter to ask for PRIORITY REVIEW OF SCENESSE AND APPROVAL . We want to have a huge stack of letters when we arrive at the FDA to deliver them by hand. Everyone write...Get your friends to write.

Ask them to grant the Priority Review and approve Scenesse as soon as possible. Our dear EPP friends are suffering. Lets all help get them a treatment that works. We are all friends here and all care about each other. Please address as shown below and send to the APF for hand delivery to the FDA in one huge stack.
Begin your letter:
Scott Gottlieb, M.D.
FDA Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Dear FDA Commissioner:

Mail your letter to:
American Porphyria Foundation
4915 St. Elmo Avenue, Suite 105
Bethesda, Maryland 20814
:

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sharelooker
Posted on: Jun 25 2018, 03:20 AM


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Posts: 432

QUOTE
22/06/2018

Reinforced EU/US collaboration on medicines
Update on the European Commission/EMA–FDA bilateral of 18-19 June 2018


Senior officials from the European CommissionExternal link icon (EC), the European Medicines Agency (EMA) and the United States Food and Drug AdministrationExternal link icon (FDA) held their 2018 bilateral meeting in Brussels, Belgium, on 18 and 19 June. The two-day bilateral regulatory dialogue allowed the strategic partners to review their ongoing cooperative initiatives, discuss strategic priorities for the coming years and further strengthen the continuous close collaboration with specific action in the field of pharmaceuticals.

The collaboration between EMA and FDA formally started in 2003 and has gone from strength to strength. The two agencies have daily interactions, most of them structured around working groups or ‘clusters’, with the aim to advance scientific and regulatory excellence worldwide.

Topics discussed at the 18-19 June meeting included:

The EU-US mutual recognition agreement (MRA) on pharmaceutical inspections on good manufacturing practices ('GMP') which came into operation in November 2017. The agreement allows the recognition of each other’s inspection outcomes of manufacturing sites for human medicines and hence better use of inspection expertise and resources. EC/EMA and the FDA discussed the progress made and experience gathered in the implementation of this agreement, which presently covers 14 EU Member States. Plans for the agreement to be operational in all EU Member States by 15 July 2019 are on track. The two parties committed to continue to work closely together at a technical level to further streamline the process, measure progress made, and monitor closely the implementation of the MRA. The partners also confirmed their intention to consider including veterinary medicines in the scope of the MRA no later than July 2019 and vaccines and plasma derived pharmaceuticals no later than July 2022.

Advanced therapies (ATMPs): ATMPs, comprising gene therapies, tissue engineered products and somatic cell therapies, have the potential to reshape the treatment of a wide range of conditions, particularly in disease areas where conventional approaches are inadequate. Regulators on both sides of the Atlantic are actively supporting the development of these novel medicines and are facing similar regulatory challenges. The parties therefore agreed to encourage early parallel scientific advice and to further strengthen the existing ‘cluster’ on ATMPs with a view to develop common scientific approaches on the regulation of these medicines, that could best facilitate their preclinical and clinical development, and the way data collection on these medicines can be optimised after authorisation.

Generic medicines: The opportunity was taken to better understand the fundamentals of legal, regulatory and scientific requirements for approving generic and hybrid applications on both sides and to identify possible ways of streamlining the scientific requirements for such approvals with a particular focus on complex generics (FDA) and hybrids (EU). Options for next steps included the continued access for companies to EMA-FDA parallel scientific advice and further collaboration between regulators on the product-specific guidelines they develop.

Real-World Evidence (RWE): RWE has been used for the post-authorisation monitoring of medicines for many years, and EC/EMA and FDA agreed that RWE holds major promise to strengthen decision-making on medicines throughout their lifespan. There are benefits from transatlantic collaboration to leverage expertise, experience and available data. Collaboration will help to address methodological and practical challenges and in analysing RWE. The parties collaborate on RWE, whereby EMA and FDA will regularly exchange information and work together on methodologies to optimise the use of RWE to support regulatory decision making throughout the product lifecycle.
The EC/EMA and FDA will continue their strong cooperation in numerous activities under their responsibilities, including innovation. The activities planned in the next couple of years will need to take into account EMA’s business continuity needs during and after its relocation to Amsterdam.


http://www.ema.europa.eu/ema/index.jsp?cur...b01ac058004d5c1
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sharelooker
Posted on: Jun 24 2018, 06:27 PM


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Posts: 432

The case of Alkermes was odd. Although they got a RTF letter on 02/04/18, two weeks later the NDA was accepted.

http://phx.corporate-ir.net/phoenix.zhtml?...&ID=2342624
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sharelooker
Posted on: Jun 22 2018, 04:56 AM


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https://clinicaltrials.gov/ct2/show/NCT0352...yria&rank=4
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sharelooker
Posted on: Jun 21 2018, 11:42 PM


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Posts: 432

Great find, FZ! So on the list, there are 95 appeals and only six rejections?Does it mean, that there is a good chance of a successful appeal for CUV?

Here's an example of a so called "Managed access agreement" which i think was proposed by British Association of Dermatologists.

https://www.nice.org.uk/guidance/ta397/reso...-pdf-2665741069
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sharelooker
Posted on: Jun 21 2018, 09:25 PM


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Posts: 432

QUOTE
Afamelanotide for treating erythropoietic protoporphyria [ID927]: Notice of Appeal

NICE has received four appeals against the Final Evaluation Determination on the above HST evaluation from the following organisations:

Clinuvel UK Ltd
International Porphyria Patient Network
British Porphyria Association
British Association of Dermatologists
The appeal panel will convene on Monday 30 July 2018 at NICE, 10 Spring Gardens, London, SW1A 2BU to hear oral representations from the appellants.

Members of the public, including consultees and commentators for this appraisal, and the press, may request to attend the hearing. The number of places for observers is constrained by the venue, and priority will be given to members of the public who are not employed by the appellant. There are twenty five places available for this appeal hearing.

Where possible, requests to attend should be made using the form that will be available on the Institute’s website https://www.nice.org.uk/event/porphyria-afamelanotide-appeal This form will be available from 20 June 2018 only. The website registration will allow requests to attend to be granted on a first-come, first-served basis. The registration period for this appeal will end at 5pm on 4 July 2018. Further details relating to public attendance at this appeal are available on the same webpage as above.

A limited number of places at the appeal hearing will be reserved for members of the public who do not have access to the internet. These places should be applied for in writing, addressed to the Appeals Coordinator at NICE, to arrive before 5pm on 4 July 2018. Written requests to attend will also be granted on a first-come, first-served basis.


https://www.nice.org.uk/guidance/gid-hst100.../html-content-3
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sharelooker
Posted on: Jun 14 2018, 04:26 AM


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Posts: 432

CUVs instagram channel is exploding. Almost 30 new subscribers overnight!
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sharelooker
Posted on: Jun 14 2018, 04:11 AM


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Posts: 432

A major event could be imminent! I noticed a similar trading pattern in December 2013 followed by the takeover bid from Shkreli and in September 2014 follwed by EMA approval.
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sharelooker
Posted on: Jun 11 2018, 03:25 AM


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Posts: 432

Priority review of SC is very likely. In 2017, all drugs with fast track designation got priority review. So my guess: PDUFA date on March 1, 2019.

Slide no. 16.

https://www.fda.gov/downloads/AboutFDA/Cent...s/UCM591976.pdf

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sharelooker
Posted on: Jun 5 2018, 02:23 AM


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Posts: 432

FDA Proposes Process Modernization to Support New Drug Development

QUOTE
Emphasizing the importance of safety across a drug’s lifecycle –
Safety remains a key component of our new plans. We will work to establish a unified post-market safety surveillance framework to monitor the benefits and risks of drugs across their lifecycles, both before and after approval.
Incorporating the patient voice –
Patients are the FDA’s most important stakeholder and our vision includes incorporating the patient voice in modern patient-focused drug development. In fact, all the elements in our proposal have a common thread: they ultimately serve to improve health for patients.
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sharelooker
Posted on: Jun 4 2018, 12:26 AM


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Posts: 432

The impact of the recent vitiligo post on CUVs instagram channel is quite remarkable. Since then, almost 20 new subscribers and 150 likes. I hope they will ramp up the whole vitiligo thing from now on and publish the results of the CUV103 trial soon after NDA submission. This will cause a lot of publicity, especially in facebook vitiligo groups, which have around 20k members.
  Forum: By Share Code

sharelooker
Posted on: Jun 2 2018, 06:23 AM


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Posts: 432

Google trends:
Attached image(s)
Attached Image

 
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sharelooker
Posted on: May 31 2018, 08:30 PM


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Posts: 432

SCIENTIFIC COMMUNIQUÉ II
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sharelooker
Posted on: May 27 2018, 08:46 PM


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Posts: 432

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

QUOTE
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.
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sharelooker
Posted on: May 18 2018, 04:14 AM


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Posts: 432

The NICE publication date was postponed to 27 June 2018 (previous date was 23 May). Maybe they are considering the annual reports and PSURs from the EMA!??Or further patient meetings?

https://www.nice.org.uk/guidance/indevelopment/gid-hst10009
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sharelooker
Posted on: May 12 2018, 08:49 AM


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Posts: 432

New insto!

Wil Asset Management (Liechtenstein) AG


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sharelooker
Posted on: May 4 2018, 06:44 AM


Group: Member
Posts: 432

New insto:

Acadian Asset Management LLC (https://www.acadian-asset.com/)

http://www.barrons.com/quote/stock/au/xasx/cuv


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sharelooker
Posted on: Apr 25 2018, 04:18 AM


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Posts: 432

Maybe the recent rise in sp is due to our new insto "McKinley Capital Management LLC"

https://www.mckinleycapital.com/

http://www.barrons.com/quote/stock/au/xasx/cuv
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sharelooker
Posted on: Apr 19 2018, 10:53 PM


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Posts: 432

Congrats to "MinusSinus"!!

His website and fb page contain valuable infos about CUV.

https://www.minussinus.de/2017/11/14/for-en...-of-minussinus/

https://www.facebook.com/minus0sinus/
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sharelooker
Posted on: Apr 19 2018, 12:15 AM


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Posts: 432

QUOTE
The new guidance documents will aim to make drug development more efficient and focus more on developing drugs targeted to less-common conditions where there’s a lack of available therapy and development pathways can be challenging.


QUOTE
In addition to the guidance, he said FDA is looking to set up a policy office‎ inside the Office of New Drugs in CDER that will “distill and align regulatory, clinical and scientific reasoning of review divisions to promote policy transparency and consistency.”


https://endpts.com/fda-chief-scott-gottlieb...-for-biopharma/
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sharelooker
Posted on: Apr 17 2018, 03:36 AM


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Posts: 432

double post!
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sharelooker
Posted on: Apr 17 2018, 03:36 AM


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Posts: 432

No,first they got a "Refuse-to-File" letter but after two weeks the NDA was accepted suddenly. The PDUFA date was set for January 31, 2019.

Here is the press release:

http://phx.corporate-ir.net/phoenix.zhtml?...&ID=2342624

QUOTE
DUBLIN, April 16, 2018 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ALKS 5461, a novel, once-daily, oral investigational medicine for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard antidepressant therapies. FDA's target action date for the ALKS 5461 NDA is Jan. 31, 2019.
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sharelooker
Posted on: Apr 17 2018, 01:29 AM


Group: Member
Posts: 432

https://endpts.com/in-a-stunning-about-face...ed-2-weeks-ago/

QUOTE
The change up marks another sign of the dramatic shift in the FDA’s stance on drug applications and its standards for reviews, raising some major questions for the industry as well as consumers. Since Scott Gottlieb became commissioner in 2017 after he was nominated for President Donald Trump with a mandate to speed new drug approvals, the agency reversed itself on three key drug rejections for Eli Lilly, TherapeuticsMD and Amicus, waving off its earlier demands for more work.
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sharelooker
Posted on: Apr 16 2018, 09:33 PM


Group: Member
Posts: 432

New trademark: "TSUMOYLE"

DPMA register:
https://register.dpma.de/DPMAregister/marke...52&CURSOR=4

QUOTE
Klasse(n) Nizza 03: Skin care preparations; cosmetic preparations for skin care; cosmetic preparations for skin care, preferably based on analogues of melanocyte stimulating hormone (MSH), in particular afamelanotide; cosmetic oils; skin creams (cosmetic); skin care creams (cosmetic), lotions (cosmetic) and oils (cosmetic); wrinkle removing skin care preparations; sunscreens; waterproof sunscreen; sunscreen preparations; sunscreen creams and lotions; cosmetics for protecting the skin from sunburn; sunblock; sun barriers (cosmetics); sun creams; cosmetic preparations for protecting the skin from the sun's rays; sun care lotions; compounds for skin care after exposure to the sun's rays; after-sun milks, creams, lotions and moisturizers; sun bronzers; sun-tanning preparations; cosmetics for tanning the skin including preparations for tanning without sunlight, preferably based on analogues of melanocyte stimulating hormone (MSH), in particular afamelanotide; self-tanning preparations (cosmetic); self -tanning creams (cosmetic) and lotions (cosmetic); suntan creams, lotions, oils and gels; skin rejuvenation preparations; skin rejuvenation products with and without analogues of alpha-melanocyte stimulating hormone (alpha-MSH); antiaging skincare preparations; antiaging creams, lotions, moisturizers, gels, balms and serums; cleansing creams, lotions, milks, foam, gels and masks.
Klasse(n) Nizza 05: Pharmaceuticals; pharmaceutical drugs; pharmaceutical preparations; pharmaceutical preparations, preferably based on analogues of melanocyte stimulating hormone (MSH), in particular afamelanotide; sun tanning preparations for pharmaceutical purposes, preferably based on analogues of melanocyte stimulating hormone (MSH), in particular afamelanotide; pharmaceutical preparations for skin care; pharmaceutical preparations for treating skin disorders; dermatological preparations; dermatological pharmaceutical substances; dermatological pharmaceutical products; medicinal creams for the protection of the skin; skin care creams for medical use; skin care preparations for medical use; medicated skin creams and lotions; medicated creams for application after exposure to the sun; pharmaceutical skin lotions; preparations for cleansing the skin for medical use; chemical and biological preparations, substances, reagents and compounds for the delivery and storage of pharmaceuticals which are preferably based on analogues of melanocyte stimulating hormone (MSH), in particular afamelanotide.



https://www.trademarkia.com/ctm/tsumoyle-017877349.htm

https://registrydb.com/tsumoyle.com

QUOTE
This domain name was registered the 19/03/2018 and update for the very last time the 19/03/2018. The subscription period will finish the 19/03/2020 The tsumoyle.com main IP address is 203.170.80.250 and it's located to Australia, . This domain name was registered with Crazy Domains FZ-LLC


Facebook page: "Health and Beauty"

https://www.facebook.com/Tsumoyle/
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sharelooker
Posted on: Apr 10 2018, 10:38 PM


Group: Member
Posts: 432

yes, you are right. He doesn't mention the name. However, CUV is discussed in the comments section below the video, including links to the coverages of "sphene-capital" and "Minus Sinus". So it's not a big deal to figure out the name.
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sharelooker
Posted on: Apr 10 2018, 07:40 PM


Group: Member
Posts: 432

Mr. Hasler (CEO of Sphene Capital) gives an interview on a youtube channel (100k subscribers). At 8:40 min he talks about CUV.

https://www.youtube.com/watch?v=3atqlIlNztM

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sharelooker
Posted on: Apr 8 2018, 06:36 AM


Group: Member
Posts: 432

Australian Melanoma Research Foundation

QUOTE
Nicoletta Muner
Board Member
Nicoletta is a Pharmacist with 20 years experience in the pharmaceutical industry, where she has had exposure to the entire drug development process.

As a Regulatory Affairs professional she has mostly focused on the introduction of novel medicinal products into international markets. As the Global Director of Regulatory Affairs at a pharmaceutical company, Nicoletta has had broad exposure to clinical research and has been a key member of the Australian team which led to the European marketing authorisation of a first-in-class drug.

Nicoletta is a graduate of the Australian Institute of Company Directors.


http://www.melanomaresearch.com.au/about-us/our-people
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sharelooker
Posted on: Apr 5 2018, 07:48 PM


Group: Member
Posts: 432

This report was written by Mr. David Stanton. He also wrote the report from 2010 .
(http://clinuvel.com/investors/analyst-cove...aaff6763fa75dbe)

Mr. Stanton worked for Nomura. So maybe he wanted to do an update on CUV.
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sharelooker
Posted on: Apr 4 2018, 09:38 PM


Group: Member
Posts: 432

I think the new products will contain an innovative drug delivery system (e.g. a patented liposomal or nanoparticles formulations) for herbal or simple non-prescriptive molecules that can penetrate in to deeper skin layers. This drug-delivey system can later be used for the new developed melanocortins.

The new product lines containing a new drug delivery system will create brand awareness.

  Forum: By Share Code

sharelooker
Posted on: Mar 23 2018, 04:02 AM


Group: Member
Posts: 432

Interesting!

This was posted by ODI01 on 4th of march:

QUOTE
From wallstreet-online.de

https://m.jobsdb.com/en-sg/search.do?JSRV=1...amp;JSSRC=SRLSC

VALLAURIX PTE. LTD. The selected candidate will join a global biopharmaceutical company focused on developing drugs for the treatment of a range of disorders. The company has identified patient populations with specific clinical needs. Personal Assistant to Director 02-Mar-18 jobsDB Ref. JSG400003003540618 Employer Ref. 6330498 We are looking for a responsible Personal Assistant to provide personalized secretarial and administrative support in a well-organized and timely manner. You will work on a one-to-one basis on a variety of tasks related to manager’s working life and communication. Position open to Singaporean only. Career Level:Entry Level Yr(s) of Exp:3 years Qualification: Diploma Industry: Accounting / Audit / Tax Services Job Function: Professional Services > Company Secretary Zonal Segregation: No Fixed Location Salary:Salary provided Employment Type: Full Time


Employer name on jobstreet is "PharmaVenture". Employer Reference, that can be found in the web adress, is the same (=6330498).

https://www.jobstreet.com.sg/en/job/6330498?fr=j
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sharelooker
Posted on: Mar 13 2018, 03:08 AM


Group: Member
Posts: 432

https://smanewstoday.com/2018/03/12/rare-di...linical-trials/

QUOTE
From cystic fibrosis to epidermolysis bullosa, the FDA — with Gottlieb, a physician, at the helm — appears increasingly willing to engage patient advocacy groups in designing trials that incorporate more meaningful endpoints and “real-world” data, as well as natural disease histories. It’s an effort to move beyond the traditional, randomized, and placebo-controlled trials that began before him, but which Gottlieb and the agency embrace.


QUOTE
“We’re still very much in the inception of this revolution, in a sense,” added Melmeyer, whose organization is an umbrella group of 270 patient advocacy groups. “There have not been any therapies approved based on quality-of-life indicators, but there have been ones in which reviews have been substantially influenced by patients and feedback. We’re also talking about the inclusion of patient preference information, patient experience data, and real-world evidence reported by patients.”
  Forum: By Share Code

sharelooker
Posted on: Mar 7 2018, 03:36 AM


Group: Member
Posts: 432

QUOTE
Marketing support
As the operator of successful retail outlets, and a logistical contract partner, we have an in-depth understanding of what clients want. And how to provide it. As well as delivering leading brands to clients’ shops, we also help them with a broad range of marketing support. We share our retail experience with clients, helping them develop and grow their business in a variety of ways.

These include:

Concept positioning and customer profiling
Shop spacing concept and design
Research and selection portfolio according to target group
Project operation and team management
Sales optimization
In-store communication, advertising and promotions


https://www.bs-gg.com/en/bs-retail
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