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PortugueseMan
Posted on: Jan 14 2020, 10:58 PM


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Posts: 430

106 million people is almost 1/3 of the US population... It's about 1400/1500 US EPP patients covered.
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PortugueseMan
Posted on: Jan 14 2020, 12:18 AM


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Posts: 430

Visible light in photodermatology (authors: Shanthi Narla, Indermeet Kohli, Iltefat H. Hamzavi and Henry W. Lim)published on 10 Jan 2020


Abstract

Until recently, visible light (VL) had been regarded to be without significant photobiologic effect on the skin. Updated research suggests that this is not the case and the measurable effect of visible light on the skin is being documented in all skin types. Recent studies have demonstrated that in dark-skinned individuals, visible light can induce more intense and longer lasting pigmentation of the skin compared to UVA1. This effect was potentiated when VL was combined with a small percentage of ultraviolet A1 radiation (UVA1). Further, the combination of VL + UVA1 was also able to induce erythema in light-skinned individuals, a novel finding since the erythemogenic spectrum of sunlight had primarily been attributed to ultraviolet B (UVB) and short wavelength UVA (320-340 nm). Based on these findings, VL and UVA1 may also potentially play a role in conditions aggravated by sun exposure such as phototoxicity in light-skinned patients and post-inflammatory hyperpigmentation and melasma, especially in dark-skinned individuals. Currently available organic (chemical) UV filters are not sufficient to protect the skin from the effect of VL. VL is emerging as a key player in photodermatology and additional research is needed on the cutaneous effects of VL, as well as the development of filters and other means of photoprotection against the harmful effects of the VL spectrum. The aim of this manuscript is to review the literature on the cutaneous effects of VL as well as to highlight areas of dermatology where VL may play an important role.



"The mechanism of action of afamelanotide in the treatment of EPP was postulated due to increased production of eumelanin which would serve as a scavenger of the free radicals induced by visible light..."
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PortugueseMan
Posted on: Jan 11 2020, 09:32 AM


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Posts: 430

It’s not a question of lack of faith. I truly believe in this company and in its medicine, and I’m pretty sure few here doubt it. It’s a question of common sense: Clinuvel submitted several reimbursement dossiers that have been rejected (in some cases, more than a year ago). We have the right to know what will be the next steps. Besides, 5 years after EMA approval, it would be nice to know something about the significant EPP market of the Scandinavian countries..


Let me also tell you that I didn't like the tone of your post and your aggressiveness. If you don't like what this forum turned in to, I invite you to be consistent with yourself and with your own suggestions, and to look for another forum that you like best.
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PortugueseMan
Posted on: Jan 11 2020, 01:57 AM


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Posts: 430

I completely agree with you. Management don't have to reveal/say EVERYTHING, I give them that, but they SHOULD give some updates to the market/investors. This kind of silence is ridiculous, at least.

In addition to an update on the US market, I'm still waiting for the following updates on marketing authorizations in EU countries:

1 - Will Clinuvel give up on Spain and Norway markets? Or will PW team do something regarding the negative decision of those two national drug agencies?

2 - How long will we wait for NICE to answer? one more month? one more year?

3 - Has the reimbursement dossier been handed over to the french authorities (as promised to the french EPP sufferers)? If not, why?

4 - Has anything been done about Sweden, Denmark and Finland?
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PortugueseMan
Posted on: Jan 8 2020, 08:24 PM


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Posts: 430

What I don't understand is the interest in quoting a post/link/press release from november 11, 2019... If there's nothing new about MT-7117, why do you bring the subject up again?
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PortugueseMan
Posted on: Jan 7 2020, 10:57 PM


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Posts: 430

New Drug Therapy Approvals 2019 - FDA (FDA’s Center for Drug Evaluation and Research - January 2020)

First-in-Class

CDER identified 20 of the 48 novel drugs approved in 2019 (42%) as first-in-class, which is one indicator of the drug’s potential for strong positive impact on the health of the American people. These drugs often have mechanisms of action different from those of existing therapies. Novel drugs approved in 2019 that FDA identified as first-in-class were: Adakveo, Balversa, Cablivi, Evenity, Givlaari, Ibsrela, Nourianz, Oxbryta, Padcev, Polivy, Pretomanid, Reblozyl, Reyvow, Scenesse, Turalio, Vyleesi, Vyndaqel, Wakix, Xpovio, and Zulresso.



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PortugueseMan
Posted on: Dec 31 2019, 07:02 AM


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Posts: 430

QUOTE
Avita, Tanabe and others yet to materialise are putting the squeeze on Clinuvel.


I respectfully disagree. IMO, Avita is not a Clinuvel's rival. Let's see:

FDA "has approved" Avita's "Investigational Device Exemption (IDE) application to conduct a feasibility study evaluating the safety and effectiveness of the RECELL Autologous Cell Harvesting Device (RECELL® System) for repigmentation of depigmented lesions associated with stable vitiligo."


This kind of vitiligo (the stable one) is somewhat temporary. I know several people whose vitiligo was stable for a few years, but at some point has progressed very quickly. I myself had a fairly stable vitiligo in certain areas of my body; now it is progressing quite intensely in those areas (feet, hands, armpits, neck...). Unfortunately, it is very difficult to have a stable vitiligo for many years. It may happen, but those cases are rare. All vitiligo patients know exactly what I'm talking about.

Unless there is no stress in our lives, or situations that cause us an extreme anxiety/suffering (the illness or death of someone we love, professional uncertainties, concerns about our children, etc etc), it seems to me that it is virtually impossible to have a stable vitiligo in a permanent way. Sooner or later we experience those kind of situations.
In the case of Scenesse, I have never read anywhere that its use would be limited to stable vitiligo. On the other hand, I'm convinced that the limitation to skin types Fitzpatrick IV - VI is strategic: the more obvious and unambiguous the clinical trials results are, the better. And those results are clearly more obvious in Fitzpatrick skin types IV - VI.

So if Avita is just targeting stable vitiligo patients, we are talking of a very small market. And sooner or later, those stable patients will have to resort to Scenesse.
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PortugueseMan
Posted on: Dec 18 2019, 03:32 AM


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Posts: 430

Desiree Lyon on FB (15 and 16 december 2019):

"SCENESSE for EPP news! Before the drug becomes available, the company must take preliminary steps. Those are underway now!"

"It has been outrageously long process! The fda was the hold up not the company. They will be identifying clinics and doctors to give the implant. We want to make sure each EPP person is on the list. We never give out names but want to identify areas where EPP ppl live. If you aren’t on the APF DB and want to be, PM me. That way , you will receive the upcoming info re SCENESSE and all future info. Plus, this helps us identify patient areas."

"We are trying to help make process faster."
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PortugueseMan
Posted on: Dec 16 2019, 07:32 AM


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Posts: 430

SWEDEN

published on 8 december 2019: Scenesse has been approved in the US!!


"In Sweden, TLV (Dental and Pharmaceutical Benefits Agency) has not yet approved Scenesse. Today, RMP (Swedish Porphyria Association) has a working group that works to influence TLV and to get approval in Sweden.

Are you interested in helping? Get in touch with RMP. Together we can make the difference!"
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PortugueseMan
Posted on: Dec 13 2019, 10:27 PM


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Posts: 430

Well, here you have a curious thing: Analysing criteria for price and reimbursement of orphan drugs in Spain

The authors of this study, published on 26 july 2019, already knew that AEMPS rejected Scenesse for reimbursement (see table 2). This was 3 months before the publication of the TPR, on 30 october 2019. Did management also know, back on july, about the AEMPS' rejection?

Regarding PW's interview, I missed some updates on marketing authorizations in EU countries, such as:


- the reason why Spain and Norway rejected Scenesse was pretty much the same: not enough data (safety, efficacy, whatever...). It is not supposed that, 5 years after EMA approval and 3,5 years after the first commercial deliveries, we already have enough data to present and completely refute those decisions? Or will we give up on these two markets?

- how long will we wait for NICE to answer? one more month? one more year? Since the appeal decision was crystal clear ("...it was unreasonable for the committee to state that the trial results show small benefits with afamelanotide..."), why not go ahead, right away, with a lawsuit?

- an official confirmation that the reimbursement dossier will be handed over to the french authorities until the end of the year.

- what about Sweden, Denmark and Finland? (with a total of 160-200 EPP patients)

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PortugueseMan
Posted on: Dec 11 2019, 09:01 PM


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Posts: 430

EUROPE UPDATE

FRANCE - I was informed that Clinuvel will file and submit the documents for reimbursement in the next 20 days, maximum. The french EPP patients did their part and have already responded and sent the HAS questionnaire to the AFMAP.


SPAIN - Since Clinuvel submitted a reimbursement request, and since that reimbursement request was rejected by AEMPS, I think it would make sense for Clinuvel to say what the next steps will be: will they insist on the Spanish market (and how) or will they simply give up, as this is a relatively insignificant market?

UK - After 9 months without any response from NICE, I think it makes less and less sense to keep waiting. Since it will likely take between one and two years to reach a verdict from a UK court, I say we are wasting precious time. (In my experience, for a particular situation to be quickly unblocked, it is often enough to formalize a claim.)


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PortugueseMan
Posted on: Dec 6 2019, 08:43 AM


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Posts: 430

Discovery of a Highly Selective MC1R Agonists Pentapeptide to Be Used as a Skin Pigmentation Enhancer and with Potential Anti-Aging Properties

(published yesterday in the International Journal of Molecular Sciences)

"The alpha-MSH analog NDP-alpha-MSH [Nle4, D-Phe7], also known as Melanotan-1 or afamelanotide (MT-I), is a synthetic peptide that induces skin pigmentation [48] and has been approved in Europe for treating erythropoietic protoporphyria (EPP), a skin disease involving phototoxicity which can be ameliorated by inducing skin pigmentation. MT-1 is a universal MCR agonist which can lead to unexpected side effects such as headache and nausea."


"To confirm our binding and activation results on the MC1-receptor in melanocytes, we subjected alpha-MSH-responsive mouse melanoma cells for 72 h to various concentrations of MC1R-agonist peptides (Figure 1). Peptides 1, 2, 3, and 4 reached maximal activity comparable to 100 nM NDPalpha-MSH at around 12.3 nM. Peptides 6, 8, and 7 showed significantly less activity and reached maximal activity comparable to NDP-alpha-MSH only beyond 111 nM."

"We were intrigued by the somewhat reverse dose-dependent activity of peptide 4 and tested it at lower concentrations. This revealed an optimal activity for pigmentation enhancement at 30 μM (Figure 3a). The increase in pigmentation was confirmed using Fontana-Masson staining of human abdominal skin sections treated with peptide 4, where a strong black signal indicative of melanocytes making increased amounts of melanin could be seen at the basal membrane."

"As peptide 4 was able to induce pigmentation in human skin ex vivo, we were interested if it was able to induce the expression of key melanogenesis markers melanocyte-inducing transcription factor (MITF), tyrosinase (TYR), and tyrosinase-related protein-1 (TYRP-1). By immunohistochemistry using antibodies against the three proteins, we could show that indeed peptide 4 was able to significantly induce protein expression of MITF with a maximum of +79% (p <0.05) (Figure 4a)."

"We provide evidence that the pentapeptide we selected displays specificity for the MC1R; while it only shows weak potency on MC3R and MC4R (Table 2) and no significant activation of MC2R and MC5R up to 100 μM. In contrast, alpha-MSH has been shown to have a high potency of 5 nM and below among other MCRs [53,54], besides MC1R for which it has the highest affinity."

"As one important aging mechanism is the generation of oxidative stress after UVA irradiation and Nrf2 is a main transcription factor mitigating UVA induced oxidative stress [29,30], this could indicate potential anti-aging effects for our peptide."
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PortugueseMan
Posted on: Dec 2 2019, 06:56 PM


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One of the people who signed that paper, published in a health law journal, is a lawyer. To be more precise, an IP lawyer Link.

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PortugueseMan
Posted on: Dec 2 2019, 08:31 AM


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Posts: 430

QUOTE
Market exclusivity only denies generics for the same ingredient having market access for the allotted time period. I don't think it can stop other companies developing drugs for the same specified condition (EPP), especially if the drug's formulation and active ingredients are different to afamelantotide.


Orphan drug policies: implications for the United States, Canada, and developing countries

"The seven-year market exclusivity period differs from traditional patent law in that it does not begin until the drug is granted FDA approval and is independent of the drug’s current patent status. Furthermore, if a market competitor wishes to introduce a drug for the same indication, the onus is on the competitor to prove that their drug is therapeutically superior (e.g. increased efficacy, less toxicity, etc.) when compared to the present drug indicated for the rare disease of interest. This incentive creates an attractive monopolistic market for companies interested in developing a product for any given rare disease."

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PortugueseMan
Posted on: Nov 30 2019, 10:58 PM


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Posts: 430

OMG, you're Ignoramus II puke.gif Any positive hypothesis about the future of Clinuvel is immediately attacked by you.
The mask fell off!
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PortugueseMan
Posted on: Nov 30 2019, 05:47 AM


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Posts: 430

QUOTE
I hope this drug fails, but this statement is false in this particular case... Phase 2's are normally too small to see rare side effects especially. In this case the patient population is already larger than Clinuvel's phase 3 trial.


You are the one making false statements.... 450 participants in the P2 MT-4666 trial and 409 participants in the P2 EVP-6124 trial (total of 859 patients). The P3 trial which trigered the FDA decision had 753 participants. No safety issues for 859 patients under the p2 trials and some serious gastrointestinal safety events in a universe of 753 patients under the p3 trial...

Your theory falls apart...
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PortugueseMan
Posted on: Nov 30 2019, 05:11 AM


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Posts: 430

QUOTE
To me the hepatic function trial is not alarming given they said phase 2 had "acceptable safety". They could be lying, but I don't think ANY liver issue with EPP can be considered safe considering the liver issue with EPP patients.


Take a look at MT-4666/EVP-6124.

The phase II trials (EVP-6124 and MT-4666) were designed to evaluate the safety and efficacy of the drug and everyone was saying that they were a success and that they met their primary and most secondary endpoints, showing that people on the highest dose improved over baseline.

Then came the phase III trial and the FDA decision to place it on clinical hold due to a "small number of serious gastrointestinal safety events".

You talk about MT-7117 as if you were sure it is completely safe and effective. How is it possible? Who knows if MT-7117 will not have the same fate as MT-4666? In my opinion, whoever thinks this drug will be approved is crazy, to say the least, since the odds of something going wrong during phase 3 are much much higher than the odds of everything going well. Which makes any obsessive discussion about this medicine completely ridiculous.
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PortugueseMan
Posted on: Nov 30 2019, 03:59 AM


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Posts: 430

cafepharma.com

"MTPA the Wallmart of Rare Disease CompaniesAnd not in any of the good ways.
1. Your employees widely hate you and don't trust you
2. Your leadership is selfish, ignorant, unethical and stupid
3. You are cheap and dishonest
4. You treat your customers and patients horribly
5. You are one of the least respected companies in the Industry
6. 70% employee turnover rate, that should tell you something! Again, they hate you
7. No Pipeline, No Strategy, No Vision, No Plan
I have seen this company screw over more employees, customers, patients, and providers than every company ever combined.
DO NOT COME TO WORK HERE, WE ARE ALL TRYING TO LEAVE"

"This should be a Harvard Case Study on..............
How not build and launch a biotech rare disease company. Its like if the three stooges started a company, seriously"

tongue.gif tongue.gif tongue.gif


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PortugueseMan
Posted on: Nov 29 2019, 05:53 AM


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Posts: 430

We all know what you think about Tanabe. Now it's time to move on. It makes no sense to keep talking about the same subject and to repeat the same ideas over and over again. Yes, Tanabe may be a threat, but first things first! They still have to do one or two more clinical trials and we don't even know if everything will go well for them! Will they have safety issues? Will they have efficacy issues? Will FDA approve the drug? We don't know. Any conclusion you wish to draw from here is in the realm of faith, not in the realm of facts.

Earlier I shared some comments that I found on Facebook from people who went through the MT-7117 trial. The drug seems to be effective, but it's only two or three opinions in a universe of 100 EPP patients. This reminds me the Innate Immunotherapeutics' case. Innate was working on a drug called MIS416 to treat progressive multiple sclerosis. As a shareholder, I was following two blogs of patients who were participating in the trial. Those two people were completely amazed about the effects of the drug. Life changing and all that kind of things... But then Innate Immunotherapeutics announced that the MIS416 clinical trial had failed to show any clinically meaningful benefit or statistical significance...
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PortugueseMan
Posted on: Nov 26 2019, 10:03 PM


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Posts: 430

Some comments from people who participated in the MT-7117 trials:


"This is my last weekend in the mt-7117 study. Even though it has been winter, I have been able to enjoy a lot of sun in South Texas. If you have not yet signed up, please do. We need you! These are real tan lines! 3 hours at a water park today. It was cloudy but the sun peaked through at times."


"Wow, amazing!!! This is how I felt!! You captured it all...I am 3 weeks post meds , still not hurting in the sun, waiting for the balloon to pop & start hurting again, I’m 65 first time in my life to be in the sun, I want those pills back!!!! Please PARTICIPATE!!!"

"This is great! I’m still waiting for my screening appt at UCSF. I participated in phase II and III of the Scenesse trials and now this one.Praying one of them is approved quickly so we can live our lives like you did here! Thanks for sharing!!"

"I can only speak for myself my time before 10 minutes at high noon on a sunny 90 degree day and with the drug I didnt hit a limit. There were a few days I was outside from sun up till sun down on 90 degree sunny days. I kayaked on a sunny day in a tank top from 9 am to 1:30 pm then hiked for a few hours after."

"the drug that was approved this year is an insert the size of a grain of rice that took 10 years to happen from drug trial to fda approval. I’m very grateful this drug will reach us hopefully within the year now that it’s approved. The drug trial I was in last year was MT7117 a different drug from another drug company. It was a pill I took daily. I look forward to the day when not only do we have treatment but a choice of treatment. Never ever thought I would see it in my lifetime."


"This drug changed my life! I went from having a few minutes of light tolerance to complete freedom. Filled me with hope that if any of my future grandchildren, great grandchildren and beyond inherit this debilitating disease they will have access to treatment. I’ve waited a lifetime for this."
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PortugueseMan
Posted on: Nov 25 2019, 10:12 PM


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Posts: 430

EU

"Positive Opinion adopted by consensus together with the CHMP assessment report and translation timetable.
Based on the review of the available information, the CHMP was of the opinion that the renewal of the marketing authorisation can be granted with unlimited validity. The Icelandic and Norwegian CHMP Members were in agreement with the CHMP Opinion."


https://www.ema.europa.eu/en/documents/minu...ber-2019_en.pdf



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PortugueseMan
Posted on: Nov 25 2019, 10:05 PM


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EU

The documents related to "C(2019)8845 COMMISSION IMPLEMENTING DECISION renewing and amending the marketing authorisation for the orphan medicinal product for human use "SCENESSE - afamelanotide", granted by Decision C(2014)10268(final)" can be found below:

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PortugueseMan
Posted on: Nov 22 2019, 08:15 PM


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EUROPE

Commission implementing Decision (19/11/2019)

COMMISSION IMPLEMENTING DECISION renewing and amending the marketing authorisation for the orphan medicinal product for human use "SCENESSE - afamelanotide", granted by Decision C(2014)10268(final)

link

I requested for acess to the documents. I will share them here as soon as the EC send them to me.
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PortugueseMan
Posted on: Nov 21 2019, 11:32 PM


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Posts: 430

First Treatment for Rare Photosensitivity

"JAMA. 2019;322(19):1854. doi:10.1001/jama.2019.18550


The first treatment to help adults with a rare genetic disorder spend more pain-free time in the sun has received FDA approval. Afamelanotide, marketed as Scenesse, is intended for patients with erythropoietic protoporphyria (EPP), which causes skin damage from light exposure.
Erythropoietic protoporphyria decreases activity of the heme biosynthetic enzyme ferrochelatase, causing protoporphyrin buildup in the skin’s superficial blood vessels. Light reacts with protoporphyrin to trigger severe neuropathic pain that can last for days and doesn’t respond to pain medications. Swelling, reddening, and thickening of the skin are also common.

Afamelanotide, a potent melanocortin-1 receptor agonist, is administered as a subcutaneous implant that provides photoprotection by increasing eumelanin production independent of UV radiation from sunlight.

The approval was based on 2 phase 3 clinical trials involving 163 adults with EPP in the European Union (EU) and United States who received afamelanotide or placebo implants every 60 days. After 9 months, patients in the EU trial who received afamelanotide spent a median of 6 hours in direct sunlight without pain compared with only 0.8 hours in the placebo group. After 6 months in the US trial, patients who received afamelanotide spent a median of 69.4 pain-free hours in direct sunlight compared with only 40.8 hours in the placebo group. Afamelanotide may have been less effective in the EU trial compared with the US trial because of relatively higher latitudes.

In both trials, afamelanotide also improved quality of life. The most common adverse events were headache, nausea, nasopharyngitis, and back pain."
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PortugueseMan
Posted on: Nov 21 2019, 01:51 AM


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Posts: 430

That's exactly what I've been doing over the last few weeks. I have been buying for myself and for my company. Instead of criticizing the shorters, I thank them every day for giving me the opportunity to buy more shares at these prices! Back in May 2016 I wrote something like "I will be a buyer all the way 'til 10 AUD". Now, after FDA approval and after reading the AGM presentation, I can safely say that I will be a buyer all the way 'til 50 AUD. Clinuvel is a gold mine! If the stars align and all the puzzle pieces fit together, we may be talking of a company whose future market cap will exceed 100 billions AUD.
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PortugueseMan
Posted on: Nov 15 2019, 09:58 PM


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Posts: 430

UK
I just received this email from NICE:

"Thank you for contacting the National Institute for Health and Care Excellence (NICE) regarding our guidance on afamelanotide for treating erythropoietic protoporphyria that is currently in development. I understand that this is an important issue for you however, following the committee meeting that took place on 14 March 2019, work on this evaluation is ongoing and there is no update to share at this time. I am very sorry that I am unable to be more helpful on this occasion."

grrr.gif grrr.gif grrr.gif
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PortugueseMan
Posted on: Nov 13 2019, 01:49 AM


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Posts: 430

UK

News about Scenesse are planned for 2020/2021... at least.

NICE Resource planner
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PortugueseMan
Posted on: Nov 4 2019, 10:16 PM


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Posts: 430

I just received a summary of what was said about Scenesse at the last International Porphyria Congress (Milan):

"Results of new clinical trials with American and European patients treated with afamelanotide have been presented. The results confirm that this treatment increases the tolerance time to direct sun exposure and improves the quality of life of patients. However, there is great variability among patients regarding the time of sun exposure. In American studies, 75% of patients can stay more than 2 hours under the sun before symptoms appear. Regarding Dutch patients, only 32% were able to remain exposed to the sun during this time. Among the most sensitive patients (those who can only stay less than 10 min under the sun), of the 17 Americans who received afamelanotide, all were able to exceed 10 minutes of sun exposure without symptoms. However, only 6 of the 23 Dutch were exposed for more than 10 minutes. In a trial conducted in Switzerland by Dr. E. Minder, it was also found that afamelanotide increases tolerance to the sun. The authors also observed a reduction in protoporphyrin levels and an improvement in liver function, possibly related to a smaller amount of light-activated protoporphyrin molecules that reduce liver toxicity (organ responsible for its elimination by the bile duct) .The general conclusion is that we must continue research to develop more effective therapies."

I took a look at the scientific program and identified three interventions related to EPP:

Effects of Iron supplementation in EPP and XLP - M. Balwani (New York, USA)

EPP: from bench to bedside - J. Langendonk (Rotterdam, The Netherlands)

ON LONG-TERM AFAMELANOTIDE TREATMENT SWISS RESIDENTS WITH ERYTHROPOIETIC PROTOPORPHYRIA (EPP) SHOWED SIGNIFICANTLY INCREASED LIGHT TOLERANCE AS WELL AS DECREASED PROTOPORPHYRIN AND LIVER ENZYMES - A. MINDER

I searched for studies done by the speakers and find out that the most recent study signed by Balwani and Langendonk was published in 2015! So we are in 2019, in an Internacional Congress where it is supposed to circulate updated information about medicines, and those experts are talking about the results of a 2015 study? Therefore, it's not surprisingly that AEMPS based its evaluation on old data: if experts are working with outdated data, how can we require European agencies to be up to date?
Since Clinuvel has collected essential data on safety and efficacy of Scenesse over the last 4 years, would it not make sense to publish them?
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PortugueseMan
Posted on: Nov 4 2019, 09:33 AM


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Posts: 430

SPAIN

As promised, this is what I found regarding the Spanish situation:
According to the law 10/2013, the IPT (Informes de Posicionamiento Terapéutico) are binding and the only way to change the AEMPS/GTPT decision is to request a re-evaluation based on new scientific data. The AEMPS will consider the re-evaluation of the drugs for which new scientific evidence is available (IPT regulation). The re-evaluation will be assigned to the same group/commission that made the initial report.

Nevertheless... After the IPT was written, Clinuvel had 10 days to comment it. I believe Clinuvel provided the new data regarding safety and efficacy, but if that was not enough to change the final text, it's probably that AEMPS may only accept "new scientific evidence" if it is published in a reference journal. ph34r.gif

It seems that there's no way around AEMPS... So if AEMPS says "the new scientific data must be published!", then Clinuvel has to publish them.

P.S. I found out that the Spanhis IPT are generally obsolete and that they usually discard the current scientific evidence (you can see here the cases of Simeprevir and Sofosbuvir). I also stumbled upon a lot of criticism regarding the lack of transparency and objectivity of the AEMPS evaluation groups.
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PortugueseMan
Posted on: Nov 1 2019, 09:59 AM


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Posts: 430

I believe France will evaluate Scenesse in a very different way. The mere fact that the HAS truly listens to patients will make its evaluation more similar to the FDA evaluation than to the AEMPS evaluation.

I had a very busy day and I couldn't analyze in detail the Spanish legislation. In the next few days I'll do some research and will try to understand what Clinuvel can do now in order to reverse the Spanish decision. I will share my findings ASAP.
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PortugueseMan
Posted on: Oct 31 2019, 07:04 PM


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Posts: 430

SPAIN

Spain will not reiumburse Scenesse (AEMPS pdf - 30th October 2019)

"La Dirección general de Cartera Básica de Servicios del SNS y Farmacia ha emitido la resolución de no financiación para Scenesse"

It seems that the AEMPS has used the old data to its evaluation.

Besides, sentences like "Long-term safety is unknown due to the limited duration of the studies, although there are some data from an observational study conducted in Switzerland and Italy" make me wonder where is the safety data for the last 3/4 years...

After reading the AEMPS report, I feel as if the evaluation was written 4 years ago and has just been published now. It ignores all the data collected in recent years in terms of safety and effectiveness.
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PortugueseMan
Posted on: Oct 30 2019, 07:45 PM


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Posts: 430

I have been thinking a lot about this and I will also vote for all the points on the agenda. I don't really care if those extra shares will make PW even more rich than he is now, as long as it means faster expansion of the company and its products, and a sp 5x or 10x higher than the current sp.
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PortugueseMan
Posted on: Oct 28 2019, 09:30 AM


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Posts: 430

Nice little packs of 50 and 63 shares... dry.gif
Attached thumbnail(s)
Attached Image


 
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PortugueseMan
Posted on: Oct 28 2019, 07:24 AM


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Posts: 430

Will any of you vote through ComputerShare? If so, could you please tell me the Control Number for the meeting? I sent an email to ComputerShare, but still haven't received a reply...
Thanks!!!!
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PortugueseMan
Posted on: Oct 22 2019, 06:55 PM


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Posts: 430

FRANCE - update
I contacted the HAS and asked them when the evaluation of Scenesse would be concluded. To my great surprise, I received a gentle reply (here in Portugal I would have received a big silence as a response angry.gif ). I was explained the whole process of evaluation of a drug in order to decide if it should be reimbursed (and the % of the reimbursement) and then came the last sentence before the cordial farewell: "Nous vous informons que ce produit a bien une autorisation de mise sur le marché. Toutefois, le laboratoire exploitant n’a pas déposé de demande de remboursement auprès de la HAS." Which means: Yes, the EMA authorised the drug in Europe, but Clinuvel has not submitted any refund request here in France.
I asked the French Porphyria Association if such a statement was true and they corroborated it. But they were informed (by Clinuvel?) that the reimbursement request would be submitted by the end of 2019.

It seems the french EPP patients decided to start filling the HAS questionnaire to slightly speed up the evaluation process. But first, Clinuvel needs to do its part.
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PortugueseMan
Posted on: Oct 18 2019, 11:38 PM


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Posts: 430

BRAZIL
Back in 2015 I found out that there were 18 registered EPP patients in Brazil. It's not a big number, but it would represent an annual return between €1.000.000,00 and €1.500.000,00. Besides, in a country with more than 200 million people, more cases would probably appear. With the introduction of Scenesse in the Brazilian market, 1) doctors would be more aware of the disease and its symptoms, and 2) patients, knowing about the existence of an effective treatment, would have a very strong reason to come out of the dark (literally). If we take the worst numbers of prevalence studies (1:200.000), we are talking of at least a thousand EPP sufferers.


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PortugueseMan
Posted on: Oct 18 2019, 12:09 AM


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Posts: 430

FRANCE

In the HAS website you can find a list of medicines whose evaluation has been open to patient input. Scenesse isn't in that list anymore, so we can expect a final decision from the Transparency Committee (Commission de la Transparence) by the end of this year.
You can also find in this same web adress a table with the medicines already evaluated: you can read the TC's decisions and the contributions of the patients associations (in French only).

https://www.has-sante.fr/jcms/c_2666643/fr/...des-medicaments


The Scenesse evaluation will surely appear on this link once it has been completed.

Dr. Deybach told me, in an e-mail dated 06/2015, that the CFP (French Porphyries Center) had 350 referenced EPP patients. He believed that there were at least more 150 or 200 patients that were still not known by the center.
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PortugueseMan
Posted on: Oct 16 2019, 10:28 PM


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It's probably a general questionnaire that is adapted (sometimes better than others) to each new drug.
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PortugueseMan
Posted on: Oct 16 2019, 10:21 PM


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Posts: 430

I just found out, in the HAS website, that the patients have 30 days to send their contributions (in other words, to respond to the questionnaire) and that a medicine appraisal process should take no more than 90 days.

Let's suppose that AFMAP made this questionnaire available at the beginning of october... It is legitimate to expect a final decision from HAS in late 2019/early 2020.

Drugs and medical devices: patients, contribute to their evaluation!
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PortugueseMan
Posted on: Oct 16 2019, 09:25 PM


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Posts: 430

I don't know if this was already mentioned here... As Scenesse is being evaluated in France for a reimbursement, the HAS (Haute Autorité de Santé) asked the french EPP patients to fill a questionnaire (attached) in order to make a final decision. The questionnaire includes questions such as:


- How does the disease affect the quality of life of patients?
- What are the worst difficulties?
- How does the disease affect those around? (family, relatives, caregivers...)
- Advantages and disadvantages of the most used therapies?
- What do patients expect from the new therapy (Scenesse)?
- For those who have tested the new drug, what are the positive or negative consequences of its use?

It is fantastic to see that HAS considers EPP patients' opinion relevant to their evaluation.
Attached File(s)
Attached File  questionnaire_has_afmap.pdf ( 170.83K ) Number of downloads: 30

 
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PortugueseMan
Posted on: Oct 15 2019, 11:36 PM


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Posts: 430

Clinuvel: Skin in the game - Eureka Report

Enjoy the reading smile.gif

What caught my attention:

[US]
"...in the US you’ve got Medicare and you’ve got the private insurers and they will need to pay for this treatment."

"in the case of the United States we knew that a number of patients from the United States were flying to Europe every two months to obtain the treatment, and the treatment was already reimbursed by the insurers so there is precedent that the large reimbursement provided in the US have been paying for this treatment the last four years."

"The preliminary discussions for the last two years before the insurers commit they want to see the actual FDA approval so the final discussions are now going to be taking place in the next few months so there is a two stage, there is a preliminary scoping discussion that you have with insurers to get it on the benefit list. Once you get approval that’s when they start committing to the conditions and price."

"From this moment on we are finalising discussions with the large payers to make sure that the product is on their benefit list and therefore they can cover the patient care."


[EUROPE]
"As we are still negotiating with various insurers and member states we do not disclose the penetration and number of patients because negotiations are ongoing so we have never publicly stated how many patients and how many centres we are treating but YOY we are increasing them."

"At the moment we’re in the hundreds and not yet in the thousands."

[VITILIGO]
"This is going to be our next target population, patients of skin colour of African American origin that benefit from this product."


Attached File(s)
Attached File  Clinuvel__Skin_in_the_game___Eureka_Report.pdf ( 169.88K ) Number of downloads: 128

 
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PortugueseMan
Posted on: Oct 15 2019, 08:31 PM


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Clinuvel: Skin in the game

Alan Kohler speaks with Dr Philippe Wolgen, the CEO of Clinuvel Pharmaceuticals, whose share price has skyrocketed after receiving FDA approval for a drug helping people allergic to sunlight.
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PortugueseMan
Posted on: Oct 15 2019, 06:42 PM


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Posts: 430

I bought 2602 shares after FDA approval, taking advantage of the sp drop, and I still have two pending orders to buy another thousand.

I have such confidence in this company and I am so sure that we are only at the beginning of an amazing and historical adventure that I will even make my own company a shareholder of Clinuvel. I just got a LEI code through Bloomberg (mandatory in the EU for companies that want to trade) and I'm now waiting for my bank's green light to start buying.

I don't care about shorters. In fact, I thank them for offering me the possibility to buy more shares at reduced prices. rolleyes.gif
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PortugueseMan
Posted on: Oct 14 2019, 05:58 PM


Group: Member
Posts: 430

I trade through my bank, which uses the Interactive Brokers platform. Every now and then, the platform releases a Reuters report on CUV. This last one was made available yesterday.


Attached File(s)
Attached File  Reuters_Stock_Report_Plus_CUV.pdf ( 289.76K ) Number of downloads: 393

 
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PortugueseMan
Posted on: Oct 12 2019, 01:09 AM


Group: Member
Posts: 430

2018 Annual Report

Here you have the 2018 Annual Report (pdf format)

Check page 57.
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PortugueseMan
Posted on: Oct 12 2019, 12:00 AM


Group: Member
Posts: 430

"Although, I wonder if some of the "shareholders" are mutual funds/brokerages that are holding shares for multiple investors."

Your assumption is correct!

Top 20 shareholders 2018

We will have to wait for the 2019 Annual Report to check if there have been changes or if everything remains more or less unchanged.
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PortugueseMan
Posted on: Oct 11 2019, 09:22 PM


Group: Member
Posts: 430

I'm not a top shareholder, but I have a good amount of shares and I am precisely one of those long termers who will not sell them if a takeover takes place. Regardless of the amount offered for each share.

Distribution of shareholder numbers - 2018
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PortugueseMan
Posted on: Oct 10 2019, 07:38 PM


Group: Member
Posts: 430

Dear sirs, we have to improve the quality of these teleconferences! Today there are audio equipments that allow a top quality audio, and it only takes a few hundred dollars to buy them. It's very hard to me to hear these crappy conference calls from a 2 billion dollar company. Looks like I'm listening to Neil Armstrong communicating with NASA in 1969 grrr.gif

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PortugueseMan
Posted on: Oct 9 2019, 09:23 AM


Group: Member
Posts: 430

I can't help myself... I bought some more shares weirdsmiley.gif When will I be able to stop??!!! lmaosmiley.gif lmaosmiley.gif lmaosmiley.gif
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PortugueseMan
Posted on: Oct 9 2019, 07:27 AM


Group: Member
Posts: 430

I am in the living room watching the news and with the same thought always in mind: we are so lucky! Lucky because we took the "Clinuvel" train several years ago, lucky because we never stopped believing in this wonderful drug and lucky because we are part of a very small group of people who know that even now, after the FDA approval in the US, we will continue to make money if we continue to buy CUV shares! tongue.gif
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PortugueseMan
Posted on: Oct 9 2019, 04:35 AM


Group: Member
Posts: 430

Congratulations to all of us!!!!! It’s an amazing day, certainly a day to remember! And a big big big thank you to Desiree Lyon and the APF. I’m convinced that without them the result today would be different.
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PortugueseMan
Posted on: Oct 9 2019, 12:58 AM


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Posts: 430

2nd approval today out graduated.gif
Dilaudid
NDA #019892
Hydromorphone Hydrochloride Tablet; Oral SUPPL-35 Rhodes Pharms Labeling Approved
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PortugueseMan
Posted on: Oct 7 2019, 07:02 AM


Group: Member
Posts: 430

  Forum: By Share Code

PortugueseMan
Posted on: Sep 23 2019, 07:06 PM


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Posts: 430

October 6th... almost there!!! wacko.gif

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PortugueseMan
Posted on: May 30 2019, 08:54 AM


Group: Member
Posts: 430

My vitiligo is also running down that road... sadsmiley02.gif It's not easy, but I tell myself every day that a cancer would be infinitely worse.
Regarding my company, as we say here in Portugal, the secret is the soul of business graduated.gif
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PortugueseMan
Posted on: May 30 2019, 01:42 AM


Group: Member
Posts: 430

I have 40 years. At 31, shortly before my first child was born, I noticed a small white spot on my body. It was the first time I heard of vitiligo and, as it's easy to imagine, my world collapsed. I started doing a lot of research on the internet about the disease, but it was only a few years later that I became aware of Clinuvel. I immediately decided to buy shares since I was absolutely sure to have found a company with a huge potential. I invested over 60% of all the money I had then. I was not rich, all I had was the result of my work and of my wife's work. Therefore, it was not easy to separate myself from money it was so hard to save... but I felt deep inside that I had to do it. I remember hearing my wife asking me, several times, if I was sure of what I was doing... I remember those days when I looked at the share price and verified that I was losing more than 50% of the amount invested... the whirlwinds in my head...

Two years ago I created a very successful small business here in Portugal (the reason why I had to stop participating in this forum). I still have not sold a single share and I don't plan to do it in the next years. What I now earn from my business allows me to "forget" those shares, and since I came here because of vitiligo I decided not to sell my shares (or part of them) until Scenesse is finally being used to treat vitiligo.

I am somehow living in a retirement (does this sentence make sense in English?). My business allows me to work the hours I want, on the days I want. I am always with my children, I take them to school, to their activities after school, I am present in all of my little son's tennis trainings, I stay at home whenever one of my children is sick and can't go to school, I play with them, I travel with them... In fact, I do what I see many grandparents doing smile.gif
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PortugueseMan
Posted on: May 21 2019, 06:38 PM


Group: Member
Posts: 430

Do you think there will be a stock split in the coming months, especially if we get a FDA approval? Or is there any interest in keeping th sp high?
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PortugueseMan
Posted on: May 17 2019, 08:20 PM


Group: Member
Posts: 430

Hi!
Now that our billion dollar company is on the right track, do you have any suggestions of other companies worth investing in? I bought AVH when the sp was 0.088 (thanks to a tip I read here) and I'm keeping an eye on Telix Pharmaceuticals... (I love australian biopharmaceuticals biggrin.gif )
Is there any other interesting company?
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PortugueseMan
Posted on: Nov 26 2018, 09:31 PM


Group: Member
Posts: 430

Back in 2015, Dr. Jean-Charles Deybach told me this via email:
"There are at the CFP (Centre Français des Porphyries) 350 referenced EPP sufferers and probably 150 to 200 sufferers who were not diagnosed/that are unknown to the center."
Therefore we can assume that there are at least 500 EPP patients in France, 350 of which had already been identified in 2015. Now, in 2018 (after three years), I believe that the number of referenced french EPP patients is very close to 400.
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PortugueseMan
Posted on: Nov 21 2018, 10:09 AM


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Posts: 430

Well, I didn’t know that Scenesse was in the process of being approved in Australia and Japan for EPP...
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PortugueseMan
Posted on: Oct 5 2018, 07:22 AM


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Posts: 430

I have vitiligo too. That’s how a simple guy from Portugal came across Clinuvel almost 5 years ago.
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PortugueseMan
Posted on: Sep 28 2018, 09:14 PM


Group: Member
Posts: 430

After reading this little article, I found myself thinking that, somehow, EMA approval was almost a miracle. Scenesse had not been approved anywhere else in the planet, and Clinuvel had only data from the clinical trials, from compassionate use and from special access schemes. FDA finds itself in a completely opposite situation: the drug has been approved in Europe (a very significant market) and, in addition to the data that I mentioned above, the FDA has also at it disposal a data set of 6,700 doses in more than 800 patients with all the related info from the adopted pharmacovigilance system. And the positive written and oral testimonies of hundreds of EPP sufferers... It is hard to believe that Scenesse will not be approved in the US.
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PortugueseMan
Posted on: Sep 28 2018, 12:56 PM


Group: Member
Posts: 430

What's the point of being rich if you don’t have access to the real money?
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PortugueseMan
Posted on: Sep 28 2018, 07:59 AM


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Posts: 430

CAD??? ph34r.gif oh my god... I mean AUD 🤪🤣
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PortugueseMan
Posted on: Sep 28 2018, 07:35 AM


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Posts: 430

I think I will sell my first shares when the share price reaches $200 CAD... I'm a believer, since the moment I bought my first shares, that CUV has the potencial to reach $2000 CAD per share, so maybe I will keep at least half of my shares until then smile.gif
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PortugueseMan
Posted on: Sep 26 2018, 05:37 PM


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Posts: 430

Here's the pdf for those interested in it.

Attached File(s)
Attached File  Reuters_Stock_Report_Plus.pdf ( 295.95K ) Number of downloads: 405

 
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PortugueseMan
Posted on: Sep 26 2018, 10:19 AM


Group: Member
Posts: 430

CUV covered by Reuters Stock Reports Plus. Recomendation: Buy. Price target: 32,70AUD.
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PortugueseMan
Posted on: Mar 19 2018, 10:22 PM


Group: Member
Posts: 430

My God... I will buy a house an open an account in the Netherlands when I get my first millions... tongue.gif

In Portugal you pay a tax of 28%...
So imagine that you want to make cash of 2,000,000 EUR, you will be taxed in 560,000 EUR.
In the Netherlands it will be only 107,800 EUR... A huge difference indeed.
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PortugueseMan
Posted on: Nov 17 2017, 08:40 AM


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Posts: 430

With an FDA approval, you can add a zero to those 25 bucks tongue.gif
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PortugueseMan
Posted on: Nov 3 2017, 09:19 AM


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Posts: 430

It's rising? I can live with that I guess...
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PortugueseMan
Posted on: Oct 17 2017, 09:34 AM


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Posts: 430

This is what caught my eye:

«As the treatment season nears an end, we are preparing the Group for expansion in 2018, and I look forward to sharing our new plans during the Annual General Meeting...»

Sounds good... very good.
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PortugueseMan
Posted on: Oct 4 2017, 07:33 AM


Group: Member
Posts: 430

Announcement: Non-Executive Director Retirement (Elie Ishag)

http://www.asx.com.au/asxpdf/20171004/pdf/43mxvv656vtj5y.pdf

"Clinuvel is undertaking a search process to appoint a new Director. The new Director will complement the current mix of skill, diversity and experience of the existing Board and will provide additional skills to support the next stage of the Company."
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PortugueseMan
Posted on: Aug 11 2017, 04:35 AM


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Posts: 430

"Melbourne, Australia and Leatherhead, UK, 2 May 2017

CLINUVEL PHARMACEUTICALS LIMITED (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that the Department of Health (DoH) has designated SCENESSE (afamelanotide 16mg) to be evaluated as a Highly Specialised Technology (HST). The re-classification acknowledges that the National Institute for Health and Care Excellence (NICE) committed an error in its earlier assessment of SCENESSE as only eligible for review under a Single Technology Appraisal (STA), a mainstream appraisal pathway."

http://www.asx.com.au/asxpdf/20170502/pdf/43hylv5054mtx0.pdf
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PortugueseMan
Posted on: Jul 12 2017, 06:13 PM


Group: Member
Posts: 430

"Chivére" is definitely not a french word and has no relation with "goat" (as Verharven said, "chèvre" is the french word for "goat")...

Larousse Dictionary

All the french words ended with "ere" (which strongest syllable is the penultimate one) have an accent in the opposite direction ("ère", as "mère", "père", "grenouillère", "atmosphère", "Molière" biggrin.gif etc).
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PortugueseMan
Posted on: Jul 10 2017, 10:38 AM


Group: Member
Posts: 430

Old news, it seems...

https://www.youtube.com/watch?v=jThZ6x86dCg
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PortugueseMan
Posted on: May 1 2017, 07:18 AM


Group: Member
Posts: 430

edit
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PortugueseMan
Posted on: Mar 23 2017, 06:59 PM


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Posts: 430

WOW!!!

"GOOD NEWS: Kostenübernahme - Remboursement - Rimborso - Reimbursement
Swiss Society for Porphyria - www.porphyria.ch

We are very happy to inform you that renowned health insurance companies have resumed reimbursement of the Afamelanotide treatment. This was possible after an intensive exchange and thanks to an amendment in the ordinance on health insurances (KVV), which has become effective on 1 March 2017. We are very grateful to these insurers and to all the others who have uninterruptedly provided reimbursement over the past few years. However, the EPP patients receiving reimbursement by these insurers cannot be fully happy, and myself I will travel to Zurich this Friday for my first Afamelanotide treatment in 2017 with mixed feelings, because other patients are still waiting for the last few health insurers to finally grant reimbursement. The inequality of treatment remains: there are insurers who reimburse, and insurers who do not reimburse, thereby violating the principle of solidarity of the basic health insurance. Nevertheless, we hope that these last insurers, like all others, will also soon grant reimbursement.
At any rate, we remain very vigilant, since the recent amendments to the ordonnance do not solve the problem of case-by-case decisions and in the long run do not guarantee durable and sustained provisioning of drugs – The risk of inequalities of treatment persists and more needs to be done at a political level to eliminate this fault in the system. So, we're not letting go! Make sure you visit this page regularly for further developments. Thank you for your support."

Change.org
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PortugueseMan
Posted on: Feb 10 2017, 05:55 PM


Group: Member
Posts: 430

World Vitiligo Day - Detroit 2017
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PortugueseMan
Posted on: Feb 1 2017, 09:38 PM


Group: Member
Posts: 430

International Congress on Porphyrins and Porphyrias 2017 - Bordeaux

Tuesday, June 27th

12h00 – 12h30 PL9 : Janneke LANGENDONK (Netherlands) : Afamelanotide (Scenesse, CLINUVEL) for the treatment of protoporphyria-induced phototoxicity, where are we ?

Agenda
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PortugueseMan
Posted on: Jan 27 2017, 07:38 PM


Group: Member
Posts: 430

News from France...

Newsletter from the French Association of the EPP sufferers (translated by me):

2016 did not bring us the long-awaited good news about the availability of Scenesse for the EPP patients. Although the distribution of the drug started in the Netherlands - and only in the Netherlands -, the French authorities are still cautious and don't seem to have understood how this drug can radically change the lives of the EPP patients, making possible for them to regain an almost normal life.
In France as in Europe, the mobilization is total. Your association is present at all stages of this fight, through clountless appeals and letters to public health agents, to the European Medicines Agency, to the Ministry of Health...

[here you can find the original text]
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PortugueseMan
Posted on: Jan 18 2017, 08:18 PM


Group: Member
Posts: 430

At the end of 2014 I bought thousands of shares of a little Australian company. the price was then 0,18 AUD.
After 2 years the sp is now 1,43 AUD.
And Innate Immunotherpeutics hasn't a single product in the market...

This is what will happen with the CUV sp very soon.

As royco said, the crowd will wake up.
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PortugueseMan
Posted on: Dec 14 2016, 05:46 AM


Group: Member
Posts: 430

Maybe he needed some money to buy a new Porsche... Each one of us has his own priorities.
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PortugueseMan
Posted on: Nov 30 2016, 08:19 PM


Group: Member
Posts: 430

It's really sad to come here everyday and see dozens and dozens of useless/childish posts... EVERYDAY!!! Thank God we still have GG.
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PortugueseMan
Posted on: Nov 28 2016, 02:25 AM


Group: Member
Posts: 430

Ignoramus' problem is that he don't have a healthy family life, real friends, a job or a hobby. Or maybe is just a sick person. I can't find other explanations for his psychotic behavior. I've decided long ago to ignore whatever he writes (I don't read his posts), and I think it's the best thing we can do, since we can't simply shut him up.
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PortugueseMan
Posted on: Oct 19 2016, 12:53 AM


Group: Member
Posts: 430

Great news smile.gif

Lara's health insurance, Intras, a company of the CSS Group, has decided to stop reimbursement of the costs of the Afamelanotide treatment after its price increase, as opposed to other insurers who have instead granted it to other patients according to Article 71b KVV. The case of Lara was reported recently by "Il Caffè" in three short articles highlighted below. Lara has not given in and courageously fought for her rights by appealing against the decision of Intras/CSS at the cantonal insurance Tribunal of the Canton of Ticino – The Tribunal found in favor of Lara and, consequently, Intras/CSS will now have to reimburse the treatment in full and at the price established for the commercialization of the drug (the reference of the decision of the cantonal Tribunal is number 36.2016.72). Lara was able to finally step out of the shadows and can now resume a normal life both on a personal level as well as professionally, no longer held hostage by a decision of an insurance preventing her from being treated by a drug so vital to her.
Visit this site regularly for further developments concerning this decision, an important step towards equality of treatment and which contributes to restore hope to all patients suffering from EPP, from whom Afamelanotide was unjustly withdrawn.

CSS must reimburse
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PortugueseMan
Posted on: Oct 10 2016, 10:05 PM


Group: Member
Posts: 430

10,10 AUD.
  Forum: By Share Code

PortugueseMan
Posted on: Jul 24 2016, 06:56 PM


Group: Member
Posts: 430

On FB:


Jean Mi: Hi Desiree, thank you for the post. How long do you anticipate the FDA taking on making a decision after the October meeting?

Desiree Lyon: Jean, I wish I knew how long...but if I am not mistaken, they must say within six months after they file the next step...I believe we will have fir next summer ....
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PortugueseMan
Posted on: Jul 22 2016, 06:13 AM


Group: Member
Posts: 430

From FB:

QUOTE
Desiree Lyon: Great News from NBC producer
Hello!

I’m excited to report that the show the you helped build, Dateline NBC’s “Out of the Shadows,” was nominated for an Emmy Award for Best Feature in a News Magazine. I can’t thank you and the entire EPP community enough for all your help. The ceremony is in September. Fingers crossed!

Tommy
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PortugueseMan
Posted on: Jul 10 2016, 12:05 AM


Group: Member
Posts: 430

Scenesse in the italian media:

Corriere della Sera
Healthdesk
Regioni
Doctor33
Quellichelafarmacia
Pharmastar

Since «Clinuvel is not available to go down a penny», I think AIFA is trying now to turn the italian patients against our company, perhaps hoping to pressure CUV to lower the price of the implants.
  Forum: By Share Code

PortugueseMan
Posted on: Jun 28 2016, 07:01 PM


Group: Member
Posts: 430

One single share to make the sp move from 4,28 to 4,45...

  Forum: By Share Code

PortugueseMan
Posted on: Jun 17 2016, 06:03 PM


Group: Member
Posts: 430

I'm pretty sure that it is true, but I would like to see an official statement.
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PortugueseMan
Posted on: Jun 14 2016, 05:45 AM


Group: Member
Posts: 430

«The good news came last Wednesday: the insurance company of Juliane Rossé finally agreed to reimburse three implants per year. This decision will allow her to live a little bit better during the sunny days.»

«For EPP not only a drug was developed, but its effects are really "miraculous".
The Australian firm that developed it [the drug] reassessed its prices by including research costs, development of applications for marketing authorization [...] For a rare disease, this is not a huge amount.»

«Germany has approved Scenesse. The reimbursement is limited to four implants, but patients don't have to pay anything.»
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PortugueseMan
Posted on: Jun 14 2016, 05:20 AM


Group: Member
Posts: 430

Another article in a Swiss newspaper (Le Journal du Jura):

http://porphyria.ch/download/JJ%2016_06_07...20du%20Jura.pdf
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PortugueseMan
Posted on: Jun 13 2016, 09:42 AM


Group: Member
Posts: 430

An EPP Expert Meeting that took place in Italy last 10th june: http://www.ifo.it/index/news/Giugno-2016/I...attie-Rare.html

Translated by Google
QUOTE
And staying on the subject of rare diseases June 10, Friday, will be held in Florence the Italian EPP Expert Meeting, a meeting of Italian experts on Protoporphyria Eritropoietica- EPP. Giovanni Leone attending the meeting, Head of the Centre for Porphyria Rare Diseases and Institute San Gallicano and Luca Barbieri, of the same center.

The protoporphyria Erythropoietic is a highly debilitating rare disease due to its dermatological expression with severe photosensitivity, which seriously compromises the quality of life for patients who can not expose themselves to the sun and should avoid the light. The Porphyria Centre at San Gallicano is one of the centers below the highest number of patients with EPP, at Italian and European level.

The purpose of the meeting in Florence is to investigate the issues related to the clinical use of the new drug Scenesse (Afamelanotide), which today is the treatment of choice, but also the only one available, for the EPP.

"Our Center - declares Leone - was the leader of the clinical trial of the drug Scenesse past years, experimentation leading to the approval at the European level and the marketing of therapy. At present there are still problems that hinder the availability of the drug on a large scale. These issues will be considered during the EPP Expert Meeting. "
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PortugueseMan
Posted on: Jun 13 2016, 05:50 AM


Group: Member
Posts: 430

Translated by Google
QUOTE
June 12, 2016 - handiness Mr Oliver Peters, Vice Director of the Federal Office of Public Health

The General Meeting of SVOI-ASOI has learned with dismay that Swiss health insurance companies have several people affected by porphyria refused the reimbursement of the cost of the drug Afamelanotide.

Based on current knowledge alone this drug enables the persons concerned a daily life that is led partially outdoors - a life as it necessarily should in Switzerland can be done.

The General Meeting of SVOI-ASOI calls you and the BAG urgently to do everything in cooperation with the affected organization in your power to ensure that Afamelanotide refunded back and is included in the list of reimbursable drugs.

unanimously adopted by the General Meeting of the Swiss Association Osteogenesis imperfecta.
Sursee, the June 5, 2016

Dr. med. Therese Stutz Steiger
President


Dr. Therese Stutz Steiger is a specialist in public health and has worked at the Swiss Federal Office of Public Health (BAG).

I found her Curriculum Vitae:

Therese Stutz Steiger is a physician specialising in prevention and public health. Since 1986, she has held several posts at the Federal Office of Public Health (BAG), mainly in middle management. In 1988/89, she did training at the London School of Hygiene and Tropical Medicine. Special areas of focus at the BAG: AIDS and addiction, dealing with new issues, health expertise, non-contagious diseases, specifically cancer. She was also involved in issues concerning the strategic orientation of the Office and has co-managed the Online Services and Empowerment sub-project which aimed to implement the eHealth Switzerland strategy initiated by the federal government and the cantons. Member of several committees and advisory boards in the public and private sectors, Therese is also active as a lecturer, teacher and writer on healthcare issues. For several years, she has been the President of AGILE Behinderten-Selbsthilfe Schweiz (organisation representing the interests of people with special needs) as a consequence of personal experience.
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PortugueseMan
Posted on: Jun 12 2016, 03:40 AM


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He had a dream...
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PortugueseMan
Posted on: Jun 10 2016, 11:38 PM


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For those interested, you can follow the FDA meeting through webcast. You just have to register here (https://www.eventbrite.com/e/scientific-wor...ion-24971245668).

"Those who register for the webcast will be emailed a link to the webcast a few days before the event. The webcast will allow you to view the workshop live, submit comments throughout the duration of the workshop, and respond to any discussion/polling questions."
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PortugueseMan
Posted on: Jun 10 2016, 11:23 PM


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From FB

QUOTE
Desiree Lyon: HOORAY The APF with your help got an EPP meeting with the FDA . As many of you that can needs to come to tell them We Need Treatment . See
Dear Stakeholder,

On behalf of the Food and Drug Administration (FDA), we invite you to an upcoming public workshop on Erythropoietic Protoporphyria (EPP) to be held October 24, 2016 from 10am-4pm (EDT) at the FDA Campus in Silver Spring, Maryland. Specific details are outlined below.


The public workshop is intended to discuss how best to facilitate and expedite the development of safe and effective drug therapies to treat signs and symptoms related to EPP. FDA will provide information for and gain perspective from patients and patient advocacy organizations, health care providers, academic experts, and industry on disease symptoms and its impact on patients' daily life, patient experience with current treatment regimens for EPP, and various aspects of clinical development of products intended to treat EPP.

We're asking you to help make this workshop a success by encouraging patients, patient representatives, health care providers, academic experts and industry to participate either in-person or through the live webcast. FDA needs your help to make this workshop a success. Please direct stakeholders to the links below to register and to learn more about the workshop.

Registration: https://eppscientificworkshop.eventbrite.com
Workshop website: Scientific Workshop on Erythropoietic Protoporphyria

We look forward to this exciting workshop and hope to see you there. If you have any questions, please feel free to contact us at meghana.chalasani@fda.hhs.gov.

Sincerely,
Meghana Chalasani


Meghana Chalasani
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Phone: (240) 402-6525
Email: meghana.chalasani@fda.hhs.gov


QUOTE
Desiree Lyon: Here is the deal. We keep pshing fiw NOW but if they dont , then this meeting is the most important thing we can do and is the biggest step to approval . These meeting are very hard to get. We can absolutly convince them for approval



I would like to add: Desiree Lyon is an amazing, wonderful human being.
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PortugueseMan
Posted on: Jun 10 2016, 09:09 PM


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Posts: 430

From FB

QUOTE
Desiree Lyon: A great idea!!!!
Rebecca Griffiths has started a brilliant EPP campaign for Afamelanotide approval.

See her letter here. We ask you all to do the same. We are going to get this drug approved.
Fighting for Afamelanotide

It's been about 6 months since our epp letter writing campaign to Dr Marcus and continued every day since then. For me personally, writing this letter proved to be very difficult. I had so much to say and found it overwhelming to describe the many aspects of this disease.
I recently felt the need to continue our fight but I wasn't quite sure how to do it. I found myself thinking many times that if Dr Marcus could see the hoops I had to jump through every moment of the day to avoid the light, then she would understand why this treatment is so very important.

I decided to start sending her short emails every single day illustrating how I had to alter my life because of EPP. It is such an easy thing to do. In Some emails I have attached photos. I have turned my frustrations into actions in hopes that a glimpse into the daily struggles will accelerate approval. I label my subject line "Living with EPP day # ---." I end every email asking for accelerated approval of Afamelanotide.
I ask that others join me. I think that daily reminders from us will keep momentum and Dr Marcus will realize that we are going to continue this fight. She is the head of the committee that approves Afamelanotide.
Thanks all,
Becky Griffithsy
Send email to :
Kendall.marcus@fda.hhs.gov

Sent from my iPhone
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PortugueseMan
Posted on: Jun 10 2016, 07:18 AM


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FDA - October 24, 2016

http://www.fda.gov/Drugs/NewsEvents/ucm501389.htm

Meeting information:

On October 24th, FDA is conducting a public workshop on Erythropoietic Protoporphyria (EPP). EPP is a group of genetic disorders that is characterized by photosensitivity that often manifests as severe pain, swelling and/or burning. The public workshop is intended to discuss how best to facilitate and expedite the development of safe and effective drug therapies to treat signs and symptoms related to EPP. FDA will provide information for and gain perspective from patients and patient advocacy organizations, health care providers, academic experts, and industry on disease symptoms and its impact on daily life, experience with current treatment regimens for EPP, and various aspects of clinical development of products intended to treat EPP. The input from this public workshop will help in developing topics for further discussion.
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PortugueseMan
Posted on: Jun 9 2016, 08:18 AM


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I would be the happiest man on earth if I had an ignore button here on SS.
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PortugueseMan
Posted on: Jun 7 2016, 11:34 PM


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Switzerland and Italy were used to pay 6,000€ and now Clinuvel is asking 20,000€, so they think it is exaggerated... Germany, for example, didn't make any noise about the price because it has not a "habit history".

Let's be honest: does anyone like to pay more when he is used to pay 3 times less?

I think the problem is not the price "per se", but the habit. We, humans, are creatures of habits... And it's very very difficult to break a habit.
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PortugueseMan
Posted on: Jun 7 2016, 08:02 PM


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The drug creates an UV shell

It was the Australian biopharmaceutical company Clinuvel that developed the drug Scenesse, whose effectiveness has been recognized by all the people we interviewed.
In 2008, Swissmedic has recognized this treatment as an orphan drug for EPP, allowing that way its reimbursement by the health insurance companies.
World's first tests of Scenesse have been made in Switzerland in 2007. Specifically, the treatment is administered under the form of a resorbable subcutaneous implant. The implants - with the size of a grain of rice - contain the active substance, afamelanotide, which stimulates the production of brown/dark pigments in the skin. Called eumelanin, the pigment is produced upon exposure to sunlight. It allows to block the penetration of light in the cells, pretty much like a shell. This phenomenon prevents the stimulation of protoporphyrin IX in the body of patients with EPP. It is this substance, toxic when exposed to sunlight, which causes the burning sensation.
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PortugueseMan
Posted on: Jun 7 2016, 07:46 PM


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Following a significant increase in prices in early 2015, the treatment for a rare disease of intolerance to light rays is not refunded anymore in Switzerland. Patients don't understand the arguments of the insurance companies.

«Imagine several blades piercing your skin. Your members are inflated, the slightest movement aggravates heartburn, you can not even relieve your itch by scratching you and it lasts for hours.»
Nadia is 25 years old. She's one of the sixty people in Switzerland affected by erythropoietic protoporphyria (EPP), a rare inherited metabolic disorder, similar to an allergy to light.
For four years now, she benefits from a treatment (a miracle of science) that allows her to live a normal life. «I can finally shop, cook, take a walk without suffering for four days because of a 20 minutes exposure to the sun.»
Nevertheless, the young medical assistant has recently received bad news. Following a tripling of the price of the drug after its official introduction in the German market, health insurance companies have decided to stop paying the drug.
Moved, Nadia tells us that «she can't imagine herself returning to her former life.»
President of the Swiss Porphyria Association and himself affected by EPP, Dr. Rocco Falchetto is surprised that «despite the existence of an effective medication and despite the fact that it is being used in our country since 2007, people suffering this martyrdom can no longer have access to that medication because of economic reasons.» The treatment is indeed very expensive. «Until the end of 2015, there was an agreement between the insurance companies and the Australian company that produces Scenesse, and the treatment was fully refunded. The price of an implant was 7,000 francs. You must take between four to six implants per year. But since this year the price of a single implant rose to 19,000 francs. The Australian biopharmaceutical justifies this increase by the fact that they are no longer in the position to provide access to the drug on a subsidised basis,» explains Rocco Falchetto.
What is even worse for the EPP sufferers is that, for the moment, the Swiss law does not allow them to make things move forward. Indeed, since Scenesse is no registered in the official list of Swissmedic (a drug homologation has has not yet been filed in Switzerland by the manufacturer), the reimbursement falls under Article 71a and 71b of the writ of Health Insurance, where it is said that the reimbursement of a treatment is exclusively decided by the insurance companies. The Swiss EPP sufferers don't agree with this legal provision: «It's not acceptable to use an economic criteria to decide about the wellbeing of citizens when there's actually a solution to their disease,» exclaims Rocco Falchetto.

A petition was created
Patients created a petition asking for the establishment of a round table to find solutions.
«We are not pointing any fingers», continues Rocco Falchetto. «But the drug exists and is effective. We simply ask to be able to access it.»
Flipping (partial) position last Thursday. Some EPP sufferers were contacted by their health insurance company and were informed that part of this year's treatment would be reimbursed, but there is no guarantees in respect of future treatments. «My insurance company will cover four injections in 2016. Usually, I take six per year. That's not bad, but I'm afraid to suffer again the same torture when the effects will dissipate,» says Nadia. «Now that I know what it is living a normal life, I can not even imagine myself going back to my old hell.»
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PortugueseMan
Posted on: Jun 7 2016, 06:40 PM


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"Burned alive, their treatment is at risk".

Published last sunday in LE MATIN, one of the biggest Swiss newspapers.
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PortugueseMan
Posted on: Jun 5 2016, 11:32 PM


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Translated by Google


- 2nd Answer by the FOPH

QUOTE
June 5, 2016 - Dear Dr. Falchetto

I refer to your below email and can assure you that we have great understanding for the situation of the patient, which you represent. Nevertheless, it should be noted that drugs that are to be paid over the compulsory health insurance (OKP), necessarily must be effective, expedient and economical. This also applies to the exceptional remuneration of drugs in individual cases in accordance with Article 71a or 71b KVV. In addition, relating to the compensation of drugs for rare diseases, the same as those applicable to the remuneration of drugs for common diseases.

The Federal Council has the postulate 10.4055 ( "National strategy to improve the health situation of people with rare diseases") adopted, which commissioned him to develop a national strategy for rare diseases in collaboration with concerned organizations and professionals as well as with the cantons. The Federal Council has adopted as a result on 15 October 2014, a national plan on rare diseases and on 13 May 2015 its implementation plan. The aim of the concept is rare diseases, patients who suffer from a rare disease, to ensure good medical care and easy access to help. This policy seeks to BAG et al consider how standardized processes can be implemented to improve the cooperation between physicians, medical officers and insurance for the reimbursement of certain medicinal products. Adjustments in relation to Articles 71a and 71b KVV are also part of the concept Rare Diseases.

Articles 71a and 71b KVV and developed by the health insurers and medical officers since the introduction of these two products models the benefit assessment have helped to standardize the evaluation process to a certain extent, so that the scope of the insurer is reduced when assessing individual cases. Nevertheless, is not ruled out that insured persons, taking the same drug therapy to complete, are assessed differently depending on health insurers. Finally, each insurer and his trust medical service for an individual and the individual patient must make a decision. The Federal Council has inter alia But in its response to the motion 12.3816 "equal treatment of patients in the access to drugs," insists that he was aware of the problems of most unequal reimbursement by insurers aware and the FOPH commissioned to continuously monitor developments in this area and to to evaluate end-2013.

The then given by the FOPH evaluation was based, first, on written surveys of working in OKP health insurers and their trust medical services. As part of these interviews was - from July 2013 to December 2013 - the practice of insurers and by the medical services in the evaluation of therapeutic value and the appropriate remuneration, charged to negotiate the actual level of compensation with the authorization holder, as well as the delivery of the drug, in detail. In addition, ten half-structured qualitative interviews with representatives of service providers, the pharmaceutical industry, medical officers and patients organizations for their assessments on the application of Article 71a or 71b KVV were performed. Patient organizations were therefore in the evaluation of the use of medicinal products under Article 71a or 71b KVV already been consulted (see the results of the evaluation at: http://www.bag.admin.ch/evaluation/01759/02074/13897/index. html? lang = en). In addition, the BAG bildetet a working group with the insurers, the medical officers and the pharmaceutical industry to discuss the way forward and the implementation of the cases referred to in Article 71a or 71b KVV further optimize. The BAG participants of the working group restricted to these organizations because they have to implement the provisions in Articles 71a or 71b KVV especially.

Finally, it should be noted that the Federal Council has agreed with the adoption of the motion 12.3816 willing to consider after the presence of the evaluation of different solutions to improve the situation in the remuneration of drugs in individual cases if necessary. In its response to the interpellation 14.3180 Humbel ( "Articles 71a and 71b KVV. Serious consequences for patients") did he also noted that the EDI and the BAG et al Check an adaptation of Articles 71a and 71b KVV. Meanwhile, the BAG is about preparing relevant regulation adjustments. All interested parties have to comment on the proposed amendments the possibility in the context of the consultation procedure, this also applies to patient organizations, such as the Swiss Society of porphyria. The documents will be on the following link: https://www.admin.ch/ch/d/gg/pc/pendent.html. Unfortunately, we are currently not able to inform you when the Federal Council will begin the consultation process.

We hope to answer these supplementary disclosures your demands sufficiently and could show you that the Federal Council and the BAG have great understanding for the situation of rare disease patients and want to achieve where possible improvements in the situation.

With kind regards

Oliver Peters
Deputy Director - Member of the Executive
Head of Directorate Health and accident insurance

Federal Department of Home Affairs
Federal Office of Public Health
Directorate Health and accident insurance
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PortugueseMan
Posted on: Jun 3 2016, 08:52 PM


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QUOTE
Clinuvel have elected to go it alone, having reportedly rejected an offer from Pfizer for EU distribution.


I don't believe it. There are no records of this. No CUV announcements, no newspaper articles to prove that that offer actually took place.
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PortugueseMan
Posted on: Jun 2 2016, 10:54 PM


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A 23 years old spanish EPP sufferer started a petition asking access to Scenesse.

23 AÑOS ESPERANDO UNA SOLUCIÓN A MI PROTOPORFIRIA
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PortugueseMan
Posted on: May 29 2016, 12:45 AM


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From FB:

QUOTE
Desiree Lyon: The APF is hosting two meetings with the FDA..one for acute porphyrias and one for epp. Details on time and place will be posted within a few weeks we hope.
Please do everything you can to come to these meetings. Every person who attends will be given the chance to speak. This is a real victory for the APF and the biggest opportunity for patients to participate in drug approval and development. Thanks to all the experts, especially Dr Desnick who has attended all the meetings and helped us tremendously. I think we are looking at October. Make it a vacation if you haven't been to DC.
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PortugueseMan
Posted on: May 26 2016, 05:24 PM


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Posts: 430

161 trades today, 90% of which were under 100 shares...



For those who don't have level 2 access you can try this website: http://www.advfn.com/stock-market/ASX/CUV/trades

Here you will find info about daily CUV trades with a 15 minutes delay. You just have to register. It's free, but use a SECONDARY email address because you will receive LOTS of advertising from ADVFN!
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PortugueseMan
Posted on: May 25 2016, 06:40 PM


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What really strikes me in this article is the big amount of comments blaming the swiss insurance companies for being greedy...
There are not many comments blaming Clinuvel.
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PortugueseMan
Posted on: May 23 2016, 07:30 AM


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Posts: 430

When Medical Research Brought Light into My Life - May 18, 2016

A very, very interesting read.


"The drug that changed my life is called Afamelanotide and is produced by an Australian company – they are the first company producing a treatment for this rare disease EPP. The substance they inject into the side of my stomach, in the form of a little implant, as small as a rice grain, has ZERO sides effects and became my best friend! Depression seized and I got back on track with my life with no pain and perfect exposure to lights."

"Eight years have passed since that moment, as I said, no sides effects. This tiny implant is a huge miracle of science, it makes me light resistant and I almost forget that I am one out 200’000 people affected by this disease."

"My insurance decided to stop paying the treatment due to the increase of the price. My Doctor tried to convince that is highly important to get the treatment but following the estimations of the insurers the pros are not sufficient to justify the costs of this treatment. I say: WHAT!? Did they ever try to spend one day avoiding lights?! This treatment is life changing for people suffering from this severe condition. I consider that there are no economic logic that can justify them to not fully reimburse the treatment."
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PortugueseMan
Posted on: May 22 2016, 12:56 AM


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Posts: 430

Answer by the FOPH (BAG) - BAG
Translated by Google
QUOTE
May 21, 2016 - Dear Dr. Falchetto

Thank you for your email of 8 May 2016 in which you as President of the Swiss Society of porphyria, the Federal Office of Public Health do (BAG) point out that you have started a petition that health insurers in future again the full cost of afamelanotide are remunerated on the compulsory health insurance (OKP). You close the Prof. Dr. Minder lodged in letter dated 4 May 2016 applications to the BAG at by wife. They therefore ask the BAG that it should clarify whether it is true that a drug would be remunerated only under the condition of registration with Swissmedic and the SFOPH for market-usual price, that is any product which, pursuant to Article 71a or 71b of the Regulation of 27 June 1995 on health insurance (KVV SR 832,102) would be applied, would not have to be compensated at the full cost. You also ask the BAG to instruct the insurer so that they should make their cost-benefit models and the applied calculations for the individual patient and transparent need and upon request, the patient is entitled Appeals decree on.

I am happy to take your concern following comments:

Drugs are generally only paid on the OKP, if they are authorized by Swissmedic and the specialties list (SL) listed. Thus they meet the criteria of effectiveness, appropriateness and efficiency. This means that the BAG sets the price of the drug, so that the criterion of cost-effectiveness is an uptake of the drug met in the SL. Exceptionally 71b paragraph 2 are KVV drugs reimbursed also on OKP if they are not approved by Swissmedic and accordingly not included in the SL, as is the case in point Afamelanotide the case under Article. Here in accordance with Article 71a paragraph 1 KVV from use of the drug has a great therapeutic benefit against a disease are expected to be fatal for the insured person or may result in severe and chronic health problems by themselves, and for lack of therapeutic alternatives as no other effective and approved is treatment available. Under Article 71b, paragraphs 3 and 4 KVV accepts the OKP the cost of the drug only on special Gutsprache the insurer, which previously consulted the medical officer or the trust doctor. The want to transfer costs must in these cases be proportionate to the therapeutic benefit. The insurer determines the amount of compensation. Orphan medicinal products are generally treated the same as drugs for treating diseases more frequent.

The health insurer has to consider, after consultation of the Medical Officer in each individual case whether the major therapeutic benefits met and no reasonable therapeutic alternative is available. If he comes to the conclusion that the large therapeutic benefit exists, it has to determine reimbursable price with the authorization holder and the service provider. If the insurer to the conclusion that the therapeutic benefit does not justify the required by the authorization holder price, he may reject the power completely.

Article 71a or 71b KVV provide that the insurer with the license holder performs corresponding price negotiations, with the aim that the OKP paid a price equal to the benefits of the product and is economical. If the medicinal product in the SL listed and works outside the approved prescribing information or the SL-limitation, the SL-price, the maximum price and the insurer can negotiate accordingly a lower price when the SL-Price is not the achievable benefits. Even in the cases of Articles 71b KVV the insurer should pay only prices that match the benefits of therapy. There is neither in the KVV yet by the BAG specifications, as the price is set by the insurers if no SL Prize is available. Insurers are geared possibly to the prices in the reference countries under Article 34abis Nursing Services Ordinance of 29 September 1995 (KLV; SR 832.112.31) apply. It should be paid on the OKP to drugs that are approved by Swissmedic and listed on the SL in the remuneration of drugs in individual cases lower costs. Thus, the incentive for the authorization holders should in particular be increased, that drugs are approved by Swissmedic and listed in the SL. For only then both Swissmedic and the SFOPH have verified that the drug is effective, safe, practical and economical. Thus, it is in the cases of Articles 71a or 71b KVV so frequently that the insurer a price considered economically, which is below the SL-price or would be included under the price at which a drug in the SL.

Although The BAG is to oversee the health insurer. The Office, however, has no competence to assess the therapeutic benefit or the pricing of the use of drugs in the individual case. The BAG thus can not examine in individual cases whether the assessment of the therapeutic benefit and to set the maximum level of compensation by the health insurers are correct. Therefore, it can not complete its opinion in the present cases. In addition, the BAG on supervision ads or disciplinary proceedings only result if the facts underlying any possible complaints not yet asserted to ordinary forms or earlier could have been invoked. The insured persons who need to be treated with Afamelanotide, but have the ability to follow the due process of law. They may require a negative available, the possibility of challenging the health insurer by objection for the health insurers. Any negative decision may then be further appealed to the cantonal insurance court. Last instance is the Supreme Court. It does not prompt the BAG to the insurers, so they issued an Executive. These are held at the request of the insured person to adopt a negative available. The insurer also has to justify its decision in the disposal. He has to put the possibility open, which is why he rejects the remuneration (eg why he the great therapeutic benefits as satisfied or frustrated considered or why he wants to reimburse the costs only partially, respectively, how he rates, which require the authorization holder, in relation to the benefits of therapy classifies as non-economic). The BAG therefore prefers not to instruct the insurer to announce their cost-benefit models.

For further questions I am gladly at your disposal.

With kind regards

Oliver Peters
vice director
Head of Directorate Health and accident insurance

Federal Department of Home Affairs
Federal Office of Public Health
Directorate Health and accident insurance



Answer to the FOPH
Translated by Google
QUOTE
May 21, 2016 - Dear Mr. Peters,

on behalf of the Swiss Society of porphyria and their representatives, thank you for your response to our concerns and the detailed explanations. There is valuable information that relating to improving our understanding of the very complex processes of costs of drugs, and we hope that we can use this in our discussions with health insurers and the license holder in order to encourage a solution within the meaning of Swiss EPP find -Patients. Especially us Product 34abis the KLV seems important because Afamelanotide has already been authorized in the EU countries and the price was published there, for example, in Germany by the Federal Joint Committee, as you can see from this document published on the Internet on page 23: https://www.g-ba.de/downloads/92-975-1355/2...famelanotid.pdf

However, we are still very concerned that the current legislation a secure and stable supply of medicines for patients suffering from rare diseases like ours, are not allowed, on the one hand because the different health insurers may take inconsistent decisions regarding costs assumed for the same drug for the same indication, and this in a way that is not clearly understandable, and secondly because patients turned practically alone and without protection, if they can not count on a strong support by individual organizations or individuals, as in our case by Prof. Dr. minder, who work with great dedication to the interests of patients. And even despite such a large and often volunteer work, it remains a very difficult and time consuming task to find solutions for these patients. These circumstances are very unfortunate and require urgent changes in the interest of patients.

But we are very worried about the notion of "efficiency" of treatment. In the case of EPP is no doubt that we can be better integrated and productive members of our society with the Afamelanotide treatment. We could more give examples: from the young woman who thanks Afamelanotide perform her nurse training and then was allowed to engage in the occupation, to the professional working man who has worked in a timber and can take on building sites thanks to the drug customers, and at the same time still is in the squad of firefighters and regularly makes inserts. All this would be impossible without Afamelanotide and these people have to fear for their jobs because they can not get the drug. We run here the risk of losing full and productive citizens, and the jobs lost, the subsequent social costs and the risk of depression or alcohol abuse, which must also be treated, and other consequences of our disease to quantify probably difficult financially exactly. Must make you feel really quantify to decide whether we deserve this treatment or not? Is the "efficiency" really suited to come to a decision about health and freedom of citizens? Our answer is a resounding No! It is clear that health care costs are high and will continue to rise with an aging society, and therefore need to find ways to optimize these costs. But we are of the opinion that it is wrong and unfair, to small, suffering and massively restricted groups of patients as to aim our to achieve this without causing a broader discussion about where it makes more sense to reduce costs, without the to put health and equality others at risk. We would like to give just one example - approval process of new drugs - our international experience with Afamelanotide showed us to very sobering way that these processes are urgently in need of reform, both in the interests of better patient care as well as to reduce drug costs. We patients suffering from rare diseases, to be in a situation of under-supply, if there is one treatment option as Afamelanotide, we perceive as a violation of our human rights to be able to enjoy the highest possible health and life achievement standards as our "normal" citizens. Our company has already achieved high standards in the equality of disadvantaged people - finally no one imagines the question whether it is economical to build a wheelchair ramp - to build them, because it is right and we are a society with high ethical principles and laws who has decided to stand up for disadvantaged citizens with disabilities to give them the best chance to lead an almost normal life. By the present situation we feel discriminates against farmers and require a clearly better protect our rights as people who suffer from a rare disease. We, and many who have supported our petition, believe that we must not simply replace with economic considerations of our human rights.

The petition has attracted the attention of the media attention and we currently hold discussions with representatives of the media to bring our concerns to the public. We hope thereby to encounter a debate that will lead to an improvement of the legal situation for patients with rare diseases. We also hope that you and the BAG Rare diseases and the revision of the KVV Article 71a and b are the draw we are seeking improvements into consideration as part of the ongoing work at the National concept, and will be happy as contacts continue to be available. In this revision, we consider it very important that in addition to the insurance companies and the pharmaceutical industry and patients organizations are consulted to ensure that the patient perspective is taken into account, and we would be grateful for a brief statement as to whether and how patient organizations be consulted in this revision. Finally, we also hope that health insurers and the authorization holder of Afamelanotide quickly reach a solution in the interests of Swiss EPP patients - the spring is already here and Summer is approaching - bad seasons for us.

I thank you and your colleagues at the BAG that you took the time for us, and that you continue to be available to us, we should have any further questions.

With kind regards,

Dr. Rocco Falchetto

President Swiss Society of porphyria
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PortugueseMan
Posted on: May 20 2016, 06:43 PM


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No distribution in France yet.

ANSM - List of drugs under enhanced surveillance (updated May 19, 2016)

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PortugueseMan
Posted on: May 20 2016, 08:31 AM


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Posts: 430

Someone decided to fill the sell side with packs of 6,000 shares. We will not break the 5 AUD today, I guess...

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PortugueseMan
Posted on: May 19 2016, 07:01 PM


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I posted on June 7 2015, replying to one of the honest posts of ignoramus ("4 implants per patient a year is all that allowed is under the terms of the EMA exceptional circumstances approval", he said...), that the EMA recommended 4 implants/year and that, as any recommendation, it could be followed or not.

Nevertheless, is good to see Dr. Wolgen confirming that clinicians are the ones who determine the number of implants per year (Dr. Deybach suggested this same thing last year).

What is sad is that ignoramus probably managed to influence quite a few SS members with all the BS he said over the last two years.
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PortugueseMan
Posted on: May 19 2016, 05:34 PM


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I will be a buyer all the way 'til 10 AUD.
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PortugueseMan
Posted on: May 19 2016, 06:07 AM


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Posts: 430

Tweet from Henrik Zeberg Jensen:
QUOTE
Ved ikke - let's see! Men enig i Stock Picking. God ven her på Twitter har peget på biotek-aktie Clinuvel. Den købte jeg er 3,2


Google translation: "Do not know - let's see! But agree with Stock Picking. Good friend here on Twitter have identified biotech stock Clinuvel. I bought at 3.2"

This guy has more than 5800 followers and works as a director at Cognizant Business Consulting in Copenhagen.
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PortugueseMan
Posted on: May 18 2016, 08:29 PM


Group: Member
Posts: 430

"Subsidised access to SCENESSE® treatment, prior to the drug’s formal commercial approval, was made possible in both Italy and Switzerland from 2010 and 2012 respectively. These two programs enabled 115 EPP patients to benefit from treatment with SCENESSE® totalling more than 200 patient years of cumulative care. Clinuvel is no longer in the position to provide access to SCENESSE® on a subsidised basis."

In the context of the announcement that was made, this is an irrelevant information. So my guess is that's a direct message to AIFA.
  Forum: By Share Code

PortugueseMan
Posted on: May 15 2016, 07:31 AM


Group: Member
Posts: 430

According to an email I received from the Norwegian Porphyria Centre, there are 43 registered patients in Norway.

So 30 patients eligible for the treatment = 69,77% of the total EPP norwegian patients.

It's not a bad number, IMO.
  Forum: By Share Code

PortugueseMan
Posted on: May 12 2016, 07:33 AM


Group: Member
Posts: 430

http://benessere.guidone.it/2016/05/10/pro...ntani-dal-sole/

"Come al solito il problema è legato alle forniture e al prezzo troppo elevato che la nostra agenzia dei farmaci (AIFA) sta cercando di trattare."

A too much high price, they say... Now that AIFA got used to pay 6,000€, they think 20,000€ is exaggerated... The problem here is not the price, but the habit.
  Forum: By Share Code

PortugueseMan
Posted on: Apr 16 2016, 07:17 PM


Group: Member
Posts: 430

CNN - Evidence mounts that sunscreen could weaken sperm

SCENESSE is the solution smile.gif
  Forum: By Share Code

PortugueseMan
Posted on: Apr 6 2016, 02:17 AM


Group: Member
Posts: 430

05/04/2016 - Newsletter
QUOTE
We expect data from the revised protocol study in Singapore to be available for analysis later this year


03/12/2015 - Positive preliminary results in Singaporean vitiligo study
QUOTE
Final results from CUV103 are expected in the first half of 2016.


The first half of 2016 is almost gone... To tell the truth I'm expecting to hear about CUV103 only in 2017... or 2018... not before that. Hope I'm wrong...
  Forum: By Share Code

PortugueseMan
Posted on: Mar 23 2016, 07:11 PM


Group: Member
Posts: 430

QUOTE
obviously, you don't have young children.


I have one of 7 and one of 4 years old... rolleyes.gif But yes, you are right. In my case, they are one of the reasons that "forced" me to reduce my activity in SS.
  Forum: By Share Code

PortugueseMan
Posted on: Mar 18 2016, 10:13 AM


Group: Member
Posts: 430

Published three days ago in the American Journal of Clinical Dermatology:

Afamelanotide: A Review in Erythropoietic Protoporphyria

A nice reading for the FDA...
  Forum: By Share Code

PortugueseMan
Posted on: Mar 15 2016, 09:22 AM


Group: Member
Posts: 430

So that represents a placement of ~5,60%... Not all is bad.
  Forum: By Share Code

PortugueseMan
Posted on: Feb 19 2016, 12:45 AM


Group: Member
Posts: 430

Orphanet Journal of Rare Diseases - 2008 EPP study

QUOTE
EPP has been reported worldwide, with prevalence ranging between 1/75,000 and 1/200,000.


In the American Porphyria Foundation site, the range goes from 1:50,000 to 1:75,000.

If we trust in the science of numbers, then we must conclude that there are between 35,000 and 140,000 EPP patients worldwide.
Of course, what we want to know (and what we care about) is how many of these patients live in Europe and in the United States, and will have access to Scenesse... As I wrote before, I'm pretty sure that we have more than 10,000 EPP patients in Europe alone. There are at least 1250 registered EPP patients in only 4 of the 31 countries of the European Economic Area (France: 350 / UK: 400 / The Nederlands: 250 / Germany: 250). Probably many more will come "out of the closet" as soon as Scenesse will be marketed in those countries.
  Forum: By Share Code

PortugueseMan
Posted on: Nov 25 2015, 07:45 AM


Group: Member
Posts: 430

I still don't understand what Wolgen and Company did since December 2014... They could have negotiated with european governments/insurances and all would be ready to start rolling after the PRAC decision. But apparently they needed 10 months (300 days!!!) to establish the "rigorous monitoring system" required by the EMA. They didn't anything else... I'm not happy at all. In fact, I'm really pissed off.
  Forum: By Share Code

PortugueseMan
Posted on: Oct 31 2015, 02:46 AM


Group: Member
Posts: 430

Finally!

http://www.ema.europa.eu/docs/en_GB/docume...WC500196245.pdfMinutes of the PRAC meeting 7-10 September 2015

Scenesse --> page 81

QUOTE
Endorsement/Refusal of the protocol

The PRAC, having considered the draft protocol version 5 in accordance with Article 107n of Directive 2001/83/EC, endorsed by consensus the protocol for the above listed medicinal product.

In addition, the MAH should perform pre-testing in several users for the inventory of activity questionnaire prior to the start of the study.

Furthermore, the MAH should address the following issues within 90 days:

· An updated study protocol together with the statistical analysis plan (SAP) where the section on data analysis is amended by providing adequate information on the analyses that will be performed.

· A discussion on risk factors and confounders and to describe their handling and incorporation in analyses upon submission of an updated study protocol and SAP.

· The scoring algorithm for the EPP - quality of life (QoL) version 2 questionnaire and inventory of activity questionnaire together with the SAP and the updated study protocol.
  Forum: By Share Code

PortugueseMan
Posted on: Oct 30 2015, 07:53 PM


Group: Member
Posts: 430

I received this PM from AZN Investor:

QUOTE
Here is a detailed explanation of the delays:

http://www.ema.europa.eu/docs/en_GB/docume...WC500196112.pdf

The point is they have 3 years worth of cash on the books if revenues stay at 2014-2015 levels.

Here's a couple of questions for you that I would love for you to post on the front page:

1) With 3 years of cash remaining, what makes you think they would do a capital raise now?

2) With final PRAC approval coming less than 45 days ago, why are you so pessimistic that revenues will not increase substantially over the next 12 months?

3) Why would you have expected more revenues in 2014-2015 when the final approval just was received in Sept 2015?

Let's see if you can man up and post the questions and your replays? We now have approval so please don't talk about the past 10 years. Let's hear your thoughts about the next 12-24 months? Will revenues rise?
  Forum: By Share Code

PortugueseMan
Posted on: Oct 28 2015, 05:04 PM


Group: Member
Posts: 430

Dear ignoramus, if that's "not too difficult", why don't you provide us the market data over the next few days?

CUV - trades 1 to 23

As trisail indicated, 8 packs of 5,000 shares were traded [or 10 packs if you add trades 3 & 4 (1,956 + 3,044) and trades 14 & 15 (again 1,956 + 3,044)].

In my opinion, the number of packs isn't important. What really matters is the fact that those packs prove us that Lagoda is still buying.
  Forum: By Share Code

PortugueseMan
Posted on: Oct 27 2015, 05:17 PM


Group: Member
Posts: 430

QUOTE
The pink sheets or the adrs are not much different than the nasdaq capital markets.


So pink sheets = nasdaq capital markets? Ignoramus would not say better!

In my country we have a saying when someone says something really absurd: "I don't know whether to laugh or cry".

  Forum: By Share Code

PortugueseMan
Posted on: Oct 27 2015, 01:09 AM


Group: Member
Posts: 430

I was asked to post the info steve wolgen shared on GG about Nasdaq Listing Requirements. You can find the complete Initial Listing Guide here.

The page steve posted was the page 9, which I provide for direct download.
Attached File(s)
Attached File  Page_9.pdf ( 55.87K ) Number of downloads: 53

 
  Forum: By Share Code

PortugueseMan
Posted on: Oct 26 2015, 09:01 PM


Group: Member
Posts: 430

On FB:

QUOTE
Desiree Lyon: The APF is advocating for FDA approval of Afamelanotide.
If you know Co-Chairs: Leonard Lance(R – NJ) or Joseph Crowley(D-NY), who Co Chair the Rare Disease Caucus, please contact me for our upcoming meeting with them.

Christopher Satriale: Desiree my son suffers from EPP and I am a police chief very close to Mr. Crowley's district. I am more than happy to help. Please let me know how to proceed.
  Forum: By Share Code

PortugueseMan
Posted on: Oct 23 2015, 07:57 PM


Group: Member
Posts: 430

QUOTE
The past year has seen the team make solid, if sometimes frustrated, progress.
-Stan McLiesh


So the CUV team was not happy with the slow progress. Nevertheless they have somehow progressed, and this is the most important part, after all.


QUOTE
In recent months Clinuvel has had the privilege of attracting new US and European institutional investors. These active investors, who have taken sizable positions, have closely followed the Company over a number of years and share the long term view of the Board and management on Clinuvel's strategic direction. On behalf of the Clinuvel Board, along with acknowledging all current shareholders of the Company, I wish to make a special welcome to these recent shareholders.
-Philippe Wolgen


So Lagoda is here to stay!


QUOTE
Significantly we witnessed an entirely different tone, with the Division for Dermatology and Dental Products expressing that SCENESSE® would be a valuable treatment for EPP patient [...] The conversion witnessed from the FDA is remarkable
since data had not yet been reviewed [...]
-Philippe Wolgen


Now it's even more obvious to me that the FDA will approve Scenesse in the US. They are completely open to the drug and they still have to read the patients' testimonies.


QUOTE
Important steps were made in the development of VLRX001 and CUV9900 by our team in Singapore. Through the joint venture VALLAURIX Pt Ltd we are now evaluating these two additional molecules. We anticipate that these members of the melanocortin family will be able to enter the clinic and made available for commercial use. The first objective is to make one of those products available as complementary treatment to SCENESSE® in vitiligo.
At the time of writing we are awaiting a comprehensive analysis from the second pilot study of SCENESSE® in vitiligo evaluated in Asian patients in Singapore (CUV103).
-Philippe Wolgen


Of course, by now Wolgen knows if those results are good or bad. And they are very good. If they weren't, his speach would be more cautious and not so enthusiastic ("made available for commercial use", "complementary treatment to SCENESSE", "the clinical use of the lead product in vitiligo is exciting", "a scientific breakthrough"...). And why in the hell would you work on a complementary treatment if the lead drug didn't work as expected?
  Forum: By Share Code

PortugueseMan
Posted on: Oct 22 2015, 07:39 PM


Group: Member
Posts: 430

New treatment for those with sensitivity to sun - ABC12

Medical Breakthroughs: Stepping into the Sunlight - News8000
  Forum: By Share Code

PortugueseMan
Posted on: Oct 21 2015, 06:35 PM


Group: Member
Posts: 430

Well, it seems I was right. Lagoda is still buying.

82,529 shares traded, which includes 7 packs of 5,000 [12 packs if you add trades 3 & 4 (1,714 + 3,286), trades 10 & 11 (4,079 + 971), trades 14 & 15 (4,526 + 474), trades 16 & 17 (2,628 + 2,372) and trades 26 & 27 (4,285 + 715)].

CUV - trades 1 to 32
  Forum: By Share Code

PortugueseMan
Posted on: Oct 19 2015, 07:38 PM


Group: Member
Posts: 430

Do you remember those packs of 5,000 shares?

Maybe I'm wrong, but I think Lagoda is still buying. The packs and the volume are back (60,680 shares traded today...).

Trades CUV - 1 to 34
  Forum: By Share Code

PortugueseMan
Posted on: Oct 15 2015, 06:37 PM


Group: Member
Posts: 430

The British Porphyria Association's Autumn Conference and AGM will be held in London on Saturday 24 October 2015.

Lachlan will be there giving an update about Scenesse and answering questions.
Attached File(s)
Attached File  London_24_10_15_InfoPack.pdf ( 477.7K ) Number of downloads: 95

 
  Forum: By Share Code

PortugueseMan
Posted on: Oct 8 2015, 07:01 PM


Group: Member
Posts: 430

Nine trades today, 25,120 shares bought.

Trades 1 to 9
  Forum: By Share Code

PortugueseMan
Posted on: Oct 7 2015, 08:07 PM


Group: Member
Posts: 430

I think we can draw several conclusions regarding Lagoda's movements.

First of all, it's clear that a fund with positions in Apple, Google, Johnson & Johnson, Exxon, Pfizer, Mastercard, Berkshire Hathaway and GlaxoSmithKline only invests in safe stocks (where the profits are guaranteed).
Secondly, Lagoda and its clients are firmly convinced that anything under 3,000 AUD is a good price to pay for a CUV share.
Finally, we can't forget that money makes the rules. We have now big american sharks on the boat and probably some of them knows some FDA members or some politicians with great influence in the FDA. Now we're no longer just talking about the influence of interest groups (like APF), but also about the influence of lobbies.
  Forum: By Share Code

PortugueseMan
Posted on: Oct 7 2015, 06:18 PM


Group: Member
Posts: 430

Oh gosh... And it seems they aren't done yet...
  Forum: By Share Code

PortugueseMan
Posted on: Oct 6 2015, 10:09 PM


Group: Member
Posts: 430

On FB:

QUOTE
Stewart McCallum: Desiree Lyon, first good luck with your FDA meeting. I always find it useful to have as much information as possible available to get a better understanding as to what the threshold is for getting new medicines approved and what conditions are yielding the most new treatment options. So I have attached a list of the last 5 years of approvals by the derm division the same time EPP patients have been waiting for a new treatment option. As you can see there are many meaningful conditions for which new medicines where approved such as melanoma and also a fair number of products for toe nail fungus, athletes foot, double chins and skin wrinkles...... A great starting question would be what is a higher priority for the FDA and the derm division, double chins and skin wrinkles or Porphyria?

Approved Derm Drugs Since 2010.xlsx


Desiree Lyon : Thanks so much. You are so correct , and we will use these drugs in our meeting. Some may want to quote in their letters .
This drug for Epp is under the rare disease or orphan drug status. As you know, Panhematin fir the acute porphyrias was the first Orphan Drug. We are very proud of that fact. But now Epp
Scenesse for EPP should be approved now. With everyone's help, we can make this happen . Right us on our side.


QUOTE
Marianna Donaghy Do you want letters from parents of kids with EPP? They might disregard them as only an adult treatment currently.

Desiree Lyon We want parents letters, kids letters, family letters. Everyone. We have been patient . Now is time for Epp people to rise up and tell the FDA that you are suffering and it is urgent to have a treatment.
The safety of scenes has been established over fifteen years use, the effectiveness has been established with clinical trials...now we need approval, at least the approval Europe has where it is approved for Epp use at porphyria centers.

Desiree Lyon Please send your letters to the APF. I am taking them with me. Clinuvel has been great and tried and tried and tried.
Now, ...we must be heard....we must let the FDA know we have waited long enough. Ppl are suffering terribly.
If Viagra can get approved timely...then scenesse fir Epp should be approved NOW.

Desiree Lyon Emails do not impress...the written letters are much better.
I have been doing this fir 34 years and I can tell you..if someone takes the time to write a letter and sign it, they know you mean business. Please all put your phone number with a request to call you fir your story. Why does my iPad type fir instead if for ...
I will take all the letters with me .
  Forum: By Share Code

PortugueseMan
Posted on: Oct 6 2015, 08:57 PM


Group: Member
Posts: 430

What the FDA is doing is exactly the same thing that the EMA did: to listen to the EPP sufferers. The only difference is that the FDA wants to read those testimonies, while the EMA heard them directly.

So we are watching a game which result we already know. The patient's voice will not leave any room for the FDA to refuse Scenesse.

Scenesse's approval in the US is not a question of "if" anymore, but of "when".
  Forum: By Share Code

PortugueseMan
Posted on: Sep 30 2015, 08:02 PM


Group: Member
Posts: 430

Another interesting day... 14 packs of 5,000 shares traded @2.90 AUD and then a few hundred shares driving the price down to 2.78 AUD... again!

Trades 1 to 24
  Forum: By Share Code

PortugueseMan
Posted on: Sep 29 2015, 06:50 PM


Group: Member
Posts: 430

Today's trades were very interesting. Someone is still accumulating and bought 16 packs of 5,000 shares. Then he/it decided to buy packs of less than 1,000 shares (30 of those trades were of less than 250 shares). I'm feeling that something big will happen until the end of the year.

Trades 1 to 38
Trades 39 to 76
Trades 77 to 84
  Forum: By Share Code

PortugueseMan
Posted on: Sep 28 2015, 08:03 PM


Group: Member
Posts: 430

I found this on the APF Facebook page:

Rare genetic disorder forces woman to stay inside
  Forum: By Share Code

PortugueseMan
Posted on: Sep 28 2015, 07:22 PM


Group: Member
Posts: 430

What UpToDate is:

QUOTE
UpToDate® is an evidence-based, physician-authored clinical decision support resource which clinicians trust to make the right point-of-care decisions. More than 6,000 world-renowned physician authors, editors, and peer reviewers use a rigorous editorial process to synthesize the most recent medical information into trusted, evidence-based recommendations that are proven to improve patient care and quality. More than 1 million clinicians in 174 countries and almost 90% of academic medical centers in the United States rely on UpToDate to provide the best care. That trust has been earned because of the integrity of our recommendations, including the fact that we never accept funding from pharmaceutical companies, medical device manufacturers or other commercial entities.


What they say about Scenesse:

UpToDate - Afamelanotide

QUOTE
Erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP) are cutaneous porphyrias that present in childhood with painful, non-blistering photosensitivity within minutes of sun exposure. Affected individuals must avoid sunlight, often with substantial reduction in their quality of life. Afamelanotide is a new therapy for EPP and XLP that is administered as a subcutaneous implant every other month. The mechanism involves increased melanin production; there are no effects on porphyrin levels. Two multicenter randomized trials in adults with EPP or XLP (168 patients total) found that afamelanotide substantially reduced photosensitivity and improved sunlight tolerance, with minimal toxicities. Thus, for adults with EPP or XLP, we suggest afamelanotide. This therapy is available in Europe but not in the United States.
  Forum: By Share Code

PortugueseMan
Posted on: Sep 16 2015, 08:23 PM


Group: Member
Posts: 430

List of Union reference dates and frequency of submission of periodic safety update reports (PSURs)

Excel file published by the EMA on 11 September 2015.

You can find "Afamelanotide" on line 117.
  Forum: By Share Code

PortugueseMan
Posted on: Sep 3 2015, 03:04 PM


Group: Member
Posts: 430

There's no time now to accumulate silently if you want to have hundreds of thousands of shares. Clearly, the one who is buying wants to be ready for the next announcements (CUV103, PRAC green light and ANSM reimbursement).
  Forum: By Share Code

PortugueseMan
Posted on: Sep 2 2015, 08:18 PM


Group: Member
Posts: 430

QUOTE
Clinuvel Pharmaceuticals Ltd - We've just updated the financial overview section of our website, see below for more


Financial Overview
  Forum: By Share Code

PortugueseMan
Posted on: Sep 2 2015, 12:30 PM


Group: Member
Posts: 430

JT's update #10

QUOTE
September 1, three weeks since JT's first implantation with Scenesse and he has truly experienced life changing results! As you can tell by the picture, JT is VERY happy! Nothing short of miraculous and we are eternally grateful for all of your love, support and prayers. JT's doctors are very pleased with his incredible response to Scenesse. This first implantation should keep him protected and pain free for another five or six weeks. Thank you all so very much! smile.gif
  Forum: By Share Code

PortugueseMan
Posted on: Sep 2 2015, 06:45 AM


Group: Member
Posts: 430

ICPP 2015 - International Congress on Porphyrins and Porphyrias

Clinuvel will sponsor the event.


As we already know, on Sept 13th Dr. Minder will talk about the market authorisation of Scenesse.

What I didn't know is that there will be an oral presentation about the «long-term observation of afamelanotide (Scenesse®)-treatment in 146 Swiss and Italian patients with erythropoietic protoporphyria» and a plenary lecture about «The implications of marketing authorization for Scenesse» on Sept 14th .
That day will be dedicated to the non-acute porphyrias. Dr. Deybach and Jorge Frank (the same guy who gave a conference in Munich with our CEO - link) will be there talking to worldwide specialists.
  Forum: By Share Code

PortugueseMan
Posted on: Aug 30 2015, 06:48 AM


Group: Member
Posts: 430

Interesting tweet from De Vries Cosmetic (a cosmetic centre located in Las Vegas):

QUOTE
#plasticsurgeons look out for the newest trend in off label usage pending approval from EMA &FDA--SCENESSE-tan without sun @ClinuvelNews


Tweet
  Forum: By Share Code

PortugueseMan
Posted on: Aug 28 2015, 08:58 PM


Group: Member
Posts: 430

Come on, man... Our Clinuvel is a biopharmaceutical company. The Czech Clinuvel is a company that provides medical care...
  Forum: By Share Code

PortugueseMan
Posted on: Aug 28 2015, 08:09 PM


Group: Member
Posts: 430

QUOTE
No chance at all, this ship has sailed...you will regret not increasing you bid today, for the rest of your life!!


I wish you were right, but unfortunately this stock is immune to logic. And unless the company starts to communicate, we can easily return to the $2.50 level.
  Forum: By Share Code

PortugueseMan
Posted on: Aug 28 2015, 08:02 PM


Group: Member
Posts: 430

That Czech site has nothing to do with our Clinuvel.

Google translation:


QUOTE
About us

The extent of the care provided
  • Ankle brachial pressure measurement device ABPI MD brand MESI
  • Ambulatory blood pressure monitoring device SEIVA TonoTrack
  • Blood count device TEK II mini - automatic hematology analyzer
  • CRP - indicators of inflammation in the blood unit QuickRead
  • Treatment of acute conditions, chronic care, dispensary
  • take up of specialized units and hospital wards
  • preventive care, principles of prevention, vaccination
  • Diagnostics laboratory, determine the level of sugar in the blood, ESR, urine Guidance
  • determining blood clotting device qLabs
  • ECG modern computer twelve lead electrocardiogram in the office
  • screening for celiac disease
  • examination indicators D dimer useful during diagnosis of DVT
  • spirometry for pulmonary function tests

Contractual insurance

Contractual insurance company VZP 111 VOZP 201, DP 207, ZPMVCR 211 CPZP 205th




Counseling for smoking cessation

Quitting smoking is hard, so we offer help. A trained physician, MD. Zuzana Jírovcová will provide expert advice and a helping hand in quitting smoking. When administered by quitting smoking you also have the option to ask your insurance company for a contribution to the anti-smoking.




Cooperation with the 2nd Medical School, Charles University in Prague
The office is collaborating teaching facility of the 2nd Medical School, Charles University in Prague. You are here during office hours to meet with students in 6th year demonstration practice. Students should participate in the investigation process, to help establish the diagnosis, participate in home visits to the sick, draw blood, give injections, EKG read out and solve all cases according to their knowledge and capabilities under the guidance of the prescribing physician.




The operator of surgery
Clinuvel Ltd.
In 3305/9 Okrouhlíku
150 00 Prague 5 - Smíchov
ID: 28493338
ICz: 05661000

Phone: 251 566 009
e-mail: ordinace@clinuvel.cz


Medical team
MD. Zuzana Jírovcová
Head Doctor

Sister Paul Fabiánová




  Forum: By Share Code

PortugueseMan
Posted on: Aug 27 2015, 05:06 AM


Group: Member
Posts: 430

So it seems it's a false account... What a shame! But it was expected, since we were getting too many tweets. It was too good to be true :/

Lachlan, this kind of things would be easily avoided if there were a little more communication from Clinuvel.
  Forum: By Share Code

PortugueseMan
Posted on: Aug 27 2015, 01:44 AM


Group: Member
Posts: 430

There are two new tweets on Clinuvel account and they were putted in a curious order.

Vitiligo Treatment Holds Promise for Restoring Skin Pigmentation

and then:

Results will be anounced soon

What do you guys think about this?
  Forum: By Share Code

PortugueseMan
Posted on: Aug 25 2015, 06:03 AM


Group: Member
Posts: 430

The truth is that I can not complain. The AUD is devaluing in relation to the EURO: 5000 EUROS worth 8080 AUD right now (more 1200 AUD than 3 months ago), which allows me to buy more shares with the same amount of money. On the other hand, I never
expected to see the sp so low after the EMA approval, so for me it's a great opportunity to buy more shares.

I really don't know why you people are so afraid. Do you really think Clinuvel will not be able to negotiate a reimbursement with the French/British/Dutch/German governments? If the Italian and Swiss governments/insurances companies are willing to pay for the drug, the other countries will be too. If not $8000 USD per implant, maybe $6000 or $4000, but there will be an agreement.

As for the CUV103 trial (Singapore)... The drug is still the same and does not suffer from mood swings. If it worked with the American patients it will work with Singaporean patients (mostly Fitzpatrick IV to V). I'm sure the results are great.
  Forum: By Share Code

PortugueseMan
Posted on: Aug 20 2015, 07:14 PM


Group: Member
Posts: 430

“SCENESSE®: Commercialization of a First-In-Class NCE”


Presentation from Nicoletta Muner (CUV).
  Forum: By Share Code

PortugueseMan
Posted on: Aug 19 2015, 07:37 AM


Group: Member
Posts: 430

Two twitter profiles? blink.gif

Clinuvel - twitter 1
Clinuvel - twitter 2
  Forum: By Share Code

PortugueseMan
Posted on: Aug 17 2015, 08:54 PM


Group: Member
Posts: 430

Did you guys know something about this?

ISA 2015 of Practical Dermatology - Munich (28 July - 1 August)

Thursday, 30 July 2015

Drug development in dermatology
Sponsored by Clinuvel AG

20 years of development of a novel photoprotective drug, who drives the decisions?
Jorge Frank, Düsseldorf, Germany
Philippe Wolgen, Clinuvel Pharmaceutical Ltd.
  Forum: By Share Code

PortugueseMan
Posted on: Aug 12 2015, 01:23 AM


Group: Member
Posts: 430

Since no one from Clinuvel likes to give us some good news, I will do the work.

The compassionate use of Scenesse in Italy has been renewed until the end of the year (31 december 2015).

http://www.gazzettaufficiale.it/eli/id/201....ntc-as1-guri2b
  Forum: By Share Code

PortugueseMan
Posted on: Aug 11 2015, 04:24 AM


Group: Member
Posts: 430

And with no approved drugs, it seems (pipeline).
  Forum: By Share Code

PortugueseMan
Posted on: Aug 7 2015, 06:22 AM


Group: Member
Posts: 430

Completely...

Cellceutix: Empty Office, Unviable 'Science', Misleading Disclosures, 96% Downside

This company had a mkt cap of $300M without any approved product... Incredible...
  Forum: By Share Code

PortugueseMan
Posted on: Aug 3 2015, 08:02 PM


Group: Member
Posts: 430

There's another australian company working on a vitiligo treatment, but I think it will not be a threat to Clinuvel in the short/medium term.

AVITA MEDICAL LTD: ReCell demonstrates 78% Repigmentation Compared to control
  Forum: By Share Code

PortugueseMan
Posted on: Jul 31 2015, 06:19 AM


Group: Member
Posts: 430

Not possible. In the point 2 of the form 605 you can see that the shares sold were "ordinary shares" and not "Authorised Depository Receipts" [Form 603 - Notice of initial substancial holder (30 July 2014)].
  Forum: By Share Code

PortugueseMan
Posted on: Jul 30 2015, 05:17 PM


Group: Member
Posts: 430

Maybe there are two buyers. Take a look at the Form 605, point 2, and you will see 2 movements: one of 1,000,000 shares and another of 1,627,162 shares.

The question is: if they are two NEW buyers, we will not know their identity (they will have less than 5% of the company).
  Forum: By Share Code

PortugueseMan
Posted on: Jul 29 2015, 06:23 AM


Group: Member
Posts: 430

What if Dr. Wolgen was interested in letting the sp drop in order to remove Retrophin from the way?

By the way, I'm one of those "fools" who were buying in the last few days.
  Forum: By Share Code

PortugueseMan
Posted on: Jul 22 2015, 04:31 PM


Group: Member
Posts: 430

And how do you know that?
  Forum: By Share Code

PortugueseMan
Posted on: Jul 15 2015, 02:22 AM


Group: Member
Posts: 430

QUOTE
This bill is a coin with 2 sides...


As we say in Portugal, that is a truth a La Palisse...

Everything is a coin with 2 sides. To live is a coin with 2 sides (you can suffer/be unhappy). To drive is a coin with 2 sides (you can have an accident). Scientific theories and techologies are coins with 2 sides (they can be used badly). To read your posts is a coin with 2 sides (you can read amazing BS).
  Forum: By Share Code

PortugueseMan
Posted on: Jul 11 2015, 05:12 PM


Group: Member
Posts: 430

From the BPA site

QUOTE
Autumn Conference and AGM in London, on Saturday 24 October 2015

Our Autumn Conference and AGM will be hosted by Dr Sarkany, who is one of the most experienced dermatologists on EPP and other skin porphyrias in the UK. It will be at Guys and St Thomas’ York Road Education Centre in central London (near Waterloo Station) on Saturday 24 October. The meeting will start with refreshments and registration at 10.30am for an 11am start, a light lunch will be provided in the middle of the programme and refreshments will be served to finish at 3pm.

We are still planning this event with the help of Dr Sarkany, who will also be a speaker. The BPA will hold a brief AGM and the following speakers will be in attendance as well as Dr Sarkany: a representative from Clinuvel Pharmaceuticals Ltd., a representative from Alnylam Pharmaceuticals, a window film company and two porphyria patients.

We are looking into options that will help to create access to all of our members, whether in the form of a Live Twitter Feed or through videoing the speakers.



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PortugueseMan
Posted on: Jul 11 2015, 06:51 AM


Group: Member
Posts: 430

From FB

QUOTE
Jessica Apf: ATTENTION! The APF is looking for at least 1,000 EPP patients NOW! We are organizing a giant push for the FDA. Please message me your name, address, and email address or call the APF office at 1-866-APF-3635. Thank you all!
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PortugueseMan
Posted on: Jul 11 2015, 06:47 AM


Group: Member
Posts: 430

21st Century Cures Act - Jul 10, 2015 VOTES

Result: Passed (344 AYE - 77 NO)
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PortugueseMan
Posted on: Jul 10 2015, 10:42 PM


Group: Member
Posts: 430

A program about EPP on Dutch television (July 7, 2015):

Sunny days: a hell for people with EPP

QUOTE
In the Netherlands there's about 300 people suffering from this condition.
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PortugueseMan
Posted on: Jul 10 2015, 09:57 PM


Group: Member
Posts: 430

A letter/question from a belgian Representative, Yoleen Van Camp, to the belgian Minister of Social Affairs and Health, Maggie De Block:

Question to Maggie De Block: Scenesse - EPP
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PortugueseMan
Posted on: Jul 10 2015, 08:00 PM


Group: Member
Posts: 430

QUOTE
In both trials, the primary endpoint of pain-free duration was significantly longer in afamelanotide recipients (median, 69 hours vs. 41 hours in the U.S. and 6 hours vs. 0.8 hours in the EU). Phototoxic reactions were also significantly fewer and quality of life significantly improved in the treatment group.


QUOTE
Until recently, EPP patients suffered greatly without viable therapeutic options. This we hope will change soon in the U.S. Afamelanotide has been available for EPP patients in Italy and Switzerland for over 8 years, with high adherence and a good safety profile, leading, with these results, to recent approval by the European Medicines Agency. Afamelanotide's benefit may be even greater, as some patients continued sunlight avoidance during the trial, especially those who noticed that they didn't develop hyperpigmentation. Afamelanotide may hold potential for treatment of other orphan photosensitive disorders.
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PortugueseMan
Posted on: Jul 10 2015, 07:33 AM


Group: Member
Posts: 430

Into the Light: A New Treatment for Erythropoietic Protoporphyria

Mary Wu Chang, MD, is Associate Clinical Professor of Dermatology and Pediatrics at the University of Connecticut School of Medicine; and Director, Pediatric Dermatology of New England, in West Hartford, CT. Board certified in Pediatrics, Dermatology, and Pediatric Dermatology, Dr. Chang is an active member of the Society for Pediatric Dermatology and the American Board of Dermatology Committee for Pediatric Dermatology, and is Program Chair for the Section on Dermatology of the American Academy of Pediatrics. Her clinical interests include neonatal skin diseases and birthmarks, hemangiomas and vascular malformations, atopic dermatitis, and juvenile xanthogranuloma. Dr. Chang joined the NEJM Journal Watch Dermatology board in 2003.
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PortugueseMan
Posted on: Jul 9 2015, 08:09 AM


Group: Member
Posts: 430

FOX 8 - Clinical trial at Wake Forest Baptist helps rare skin disease

QUOTE
Dr. Herbert Bonkovsky said the clinical treatment has not been approved in the United States.

“This drug has not been approved in the U.S. It’s been approved recently in Europe; it’s been available in Switzerland and Italy for about five years,” Bonkovsky said. “Based on the study that we and others in this county have just completed, the application has gone into the Food and Drug Administration requesting approval.”
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PortugueseMan
Posted on: Jul 9 2015, 08:00 AM


Group: Member
Posts: 430

From FB

QUOTE
Desiree Lyon: Fantastic. Ppl with epp are calling their local stations, telling about epp and the new afamelanotide and we are getting programs all over the place...hooray...
Dr Bonkovsky just did a program today in NC
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PortugueseMan
Posted on: Jul 9 2015, 07:49 AM


Group: Member
Posts: 430

Icahn School of Med [tweet] - 2353 followers
Tom Heston [tweet] - 89,1k followers
ATLANTA TECH BLOGS [tweet] - 2376 followers
Tom [tweet] - 4702 followers
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PortugueseMan
Posted on: Jul 9 2015, 07:41 AM


Group: Member
Posts: 430

The Tactical & Strategic Report on Clinuvel Pharmaceuticals

[«This report is designed to give readers a highly detailed insight into Clinuvel Pharmaceuticals.Whatever your interest in Clinuvel Pharmaceuticals, as a manager, analyst, investor, shareholder, or competitor, you will not find a more compelling, comprehensive or authoritative report.» From the Data Group site]
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PortugueseMan
Posted on: Jul 7 2015, 07:23 PM


Group: Member
Posts: 430

Good Morning America: New Treatment Inspires Hope for the Battle Against Sun Allergy

QUOTE
Ignoramus: So there are 3 possibilities as to the efficacy of Scenesse as a treatment for EPP.

1. None, 2 Maybe, 3 Significant.

I'm just one investor wondering which of the 3 possibilities will prove to be correct over time.


Patients's answers:
QUOTE
Rob Saupe: was just thinking that I have lived the life of another person, for 7 months! Scenesse was like living in a whole different world. Very foreign. But, I liked it! I loved it, I want some more of it!

Rob Saupe: When I was in the phase II trials for Scenesse I spent 5 hours on a boat in the middle of the day with a pair of shorts and sandals on.

William Keith Napier:Thanks Dateline I've been EPP patient for 40 year's ...an just got threw the new trail drug 3 years ago an what a difference it made.went from 5 to 10 min in sun to about 6-8 hr .

Rocco Falchetto: I wish that the Scenesse treatment will soon become available broadly, it already changed the lives of so many patients treated in Zurich, many more deserve to experience it.


Do you still want to get more info about the efficacy of Scenesse? Forget what doctors say, what Clinuvel say, what shareholders say and listen to those who received/are receiving the drug.



QUOTE
royco: The company is quiet on vitiligo and that is not a good sign looking at the history.


Wolgen already knew the results of the Singapore vitiligo trial on the 12th March, when he wrote: «Shortly a status on the vitiligo program will be given.» If the results were bad he wouldn't have spoken of the trial in the newsletter, imo. He's clearly waiting for something (maybe for the September PRAC, as KRD suggested).
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PortugueseMan
Posted on: Jul 3 2015, 11:56 PM


Group: Member
Posts: 430

ABC Nightline segment Featuring EPP, Savannah, and Porphyria Expert Dr. Desnik
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PortugueseMan
Posted on: Jul 3 2015, 08:32 PM


Group: Member
Posts: 430

Latest news/tweets with words "Clinuvel" and/or "Scenesse" in it:

Fox News - Clinuvel (2) and Scenesse (1)
MPR - Clinuvel (1)
Channel News Asia - Clinuvel (2) and Scenesse (1)
CNN Indonesia: Clinuvel (1) and Scenesse (1)
MedicalFacts - Scenesse (1)
Medical Daily - Clinuvel (2) and Scenesse (1)
Glavpost - Clinuvel (1) and Scenesse (1)
ProactiveInvestors - Clinuvel (4) and Scenesse (3)
Dermatology News - Clinuvel (1)
News Wise - Clinuvel (1)
Reuters - Clinuvel (2) and Scenesse (1)
Pediatric News - Clinuvel (1)
Health Care Asia - Clinuvel (2) and Scenesse (1)
Internal Medicine News - Clinuvel (1)
Telegraf - Clinuvel (1) and Scenesse (1)
News RBK - Clinuvel (1) and Scenesse (1)
EurekAlert - Clinuvel (1)
LifeSpace Connect - Clinuvel (2) and Scenesse (1)
MD Magazine - Clinuvel (1)
Health - Clinuvel (1)
MedPage Today - Clinuvel (1)
Health Day - Clinuvel (1)
U.S. News - Clinuvel (1)
Doctors Lounge - Clinuvel (1)
Ward Kadel (tweet) - Clinuvel (2) and Scenesse (1)
Luke Gamon (tweet) - Clinuvel (1) and Scenesse (1)
WealthEsteem.Org (tweet) - Scenesse (1)
528InvestorRelations (tweet) - Clinuvel (2)
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PortugueseMan
Posted on: Jul 3 2015, 08:00 AM


Group: Member
Posts: 430

From FB

QUOTE
Natalia Apf: Great news! The APF was able to secure another show on EPP. Don't miss NBC Nightline Episode tonight featuring the Fulkerson family and Dr. Robert Desnick: http://abcnews.go.com/Nightline
We have received a great deal of media attention within the last month. We had several major TV programs: Discovery Life "Diagnose Me" covering AIP and NBC "Dateline: Out of the Shadows" covering EPP. We also had a show on ABC’s Good Morning America and on Telemundo channel.
Thank you for sharing links, news and educating society on porphyrias. All the media attention has been greatly helping enhance porphyria education and awareness.
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PortugueseMan
Posted on: Jul 3 2015, 06:41 AM


Group: Member
Posts: 430

Medpage Today: Novel Drug Works for Photosensitivity
DoctorsLounge: Afamelanotide Beneficial in Erythropoietic Protoporphyria
Science Newsline: Treatment Reduces Symptoms in Syndrome That Causes Extreme Light Sensitivity
MedSci (China)
U.S. News: Drug Offers Hope Against Disease Where Sunlight Causes Pain
Health Day: Drug Offers Hope Against Disease Where Sunlight Causes Pain
HCPLive: Afamelanotide Beneficial in Erythropoietic Protoporphyria
Health.com: Drug Offers Hope Against Disease Where Sunlight Causes Pain
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PortugueseMan
Posted on: Jul 3 2015, 05:28 AM


Group: Member
Posts: 430

Twitter

Dermatology News: 8659 followers
Ward Kadel: 5543 followers
Saudi Medical Group: 2599 followers
NEJM: 273k followers
528InvestorRelations: 2193 followers
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PortugueseMan
Posted on: Jul 3 2015, 12:58 AM


Group: Member
Posts: 430

medicalxpress: Treatment reduces symptoms in syndrome that causes extreme light sensitivity
Health Care Asia: Implanted drug improves tolerance of sunlight in rare condition
Internal Medicine News: Afamelanotide improves erythropoietic protoporphyria
Telegraf (Ukraine)
News RBK (Russia)
LifeSpace Connect: Implanted drug improves tolerance of sunlight in rare condition
EurekAlert: Treatment reduces symptoms in syndrome that causes extreme light sensitivity
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PortugueseMan
Posted on: Jul 2 2015, 07:13 PM


Group: Member
Posts: 430

From FB

QUOTE
Andrea Carson Fulkerson: We just did Good Morning American

Desiree Lyon: Yes. We had called them weeks ago. And they called back....that they would be doing it..but didn't know you had filmed it yet as I just spoke again with them yesterday re epp incidence. We submitted the films you sent in etc to all the networks ...

Andrea Carson Fulkerson: We taped Telemundo today to

Desiree Lyon: Great. I gave them three ppl inc Savannah..dr Bissell wil be flying down after the fourth. Remember I told everyone that after the nbc dateline we would be doing a biggggggg full court press for media..all to increase awareness so to speak FDA..not to mention general public. I think you folks in the programs and APF has done a great job.
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PortugueseMan
Posted on: Jul 2 2015, 06:38 PM


Group: Member
Posts: 430

News, news, news... News everywhere.

CNN Indonesia: Orang Berpenyakit 'Vampir' Kini Bisa Terpapar Matahari
Pediatric News: Afamelanotide improves erythropoietic protoporphyria
Reuters: Implanted drug improves tolerance of sunlight in rare condition
PM360: Afamelanotide improves erythropoietic protoporphyria
Gezondheidenco (the Netherlands): Nieuwe behandeling lichtziekte EPP effectief en veilig
News Wise: Treatment Reduces Symptoms in Syndrome That Causes Extreme Light Sensitivity
Gezondheidsnet (the Netherlands): Nieuwe behandeling lichtziekte EPP effectief
Dermatology News: Afamelanotide improves erythropoietic protoporphyria
Ukranian newspaper
proactiveinvestors: Clinuvel Pharmaceuticals to offer treatment for light-induced disorder
Channel News Asia: Implanted drug improves tolerance of sunlight in rare condition
medicalfacts (the Netherlands): nieuwe behandeling lichtziekte epp effectief en veilig
BioToday (China)
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PortugueseMan
Posted on: Jul 2 2015, 06:14 PM


Group: Member
Posts: 430

QUOTE
Apologies to “badass79”, I was not aware that CUV was in a trading halt.


I have my doubts. Whenever there was a trading halt, this was announced by ASX (in 2014 there were 2 trading halts). Today the only announcement was "NEJM publishes Phase III SCENESSE studies" (link to CUV announcements).
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PortugueseMan
Posted on: Jul 2 2015, 12:45 PM


Group: Member
Posts: 430

11-year-old girl 'allergic' to sunlight

From FB

QUOTE
Desiree Lyon: Congrats also to APF. We are getting news and print media to do all these programs. Next NBC news, working on good morning America....so watch for other news etc segments.
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PortugueseMan
Posted on: Jul 2 2015, 12:39 PM


Group: Member
Posts: 430

From FB

QUOTE
Rob Saupe: was just thinking that I have lived the life of another person, for 7 months! Scenesse was like living in a whole different world.
Very foreign.

But, I liked it!
I loved it,
I want some more of it!

I'm so very thankful to the APF for making it possible for me to be a part of the best experience of my life. The Apf staff made all the arrangements and travel plans for the entire phase II trials. All I had to do is show up at the airport on time.

And now the APF is Campaigning for US (Epper's) to bring our dreams to reality!

Thank You Desiree Lyon, Natalia Apf, Jessica Apf, Yvette, the Porphyria Experts, and all the others that are helping and getting involved.

"Research....is the key to your cure!"
  Forum: By Share Code

PortugueseMan
Posted on: Jul 2 2015, 01:35 AM


Group: Member
Posts: 430

From FB

QUOTE
Desiree Lyon: Telemundo TV has contacted me to do a show on Epp. If you have Epp and live in the Los Angeles area, please contact me. They want children and adults . Please contact me ASAP

Rob Saupe: Wow, cool.
The Spanish NBC Los Angeles station.

Desiree Lyon: Yes. Wow. I told everyone that as soon as the nbc dateline show was put...we were going to push for this treatment ..and one way is huge media coverage. Yeah APF
  Forum: By Share Code

PortugueseMan
Posted on: Jul 2 2015, 01:29 AM


Group: Member
Posts: 430

From FB

QUOTE
Rob Saupe: * Personal experience. Shared on my own accord. *

When I was in the phase II trials for Scenesse I spent 5 hours on a boat in the middle of the day with a pair of shorts and sandals on. That evening at church I realized I had an actual "sunburn" on the back of my neck. It was nothing more than a mild annoyance for an EPP'er. Rolled a cold water bottle on it and forgot all about it.

Sorry, "NORMALS", a sunburn is nothing more than a mosquito bite in our lives. Lol

Please, FDA, help us.....


Desiree Lyon: believe we r getting approval. Clinuvel has never given up and has worked diligently in our behalf.


Nanelle Taylor: I got one, too! It stung and itched a little but I was happy to have it. 😅
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PortugueseMan
Posted on: Jul 1 2015, 06:42 PM


Group: Member
Posts: 430

QUOTE
are the Insurance companies in Europe willing to pay for Scenesse


I think it's important to note that, in Europe, Clinuvel will negotiate mainly with the states themselves and not with private insurance companies.
INFARMED (Portugal), AEMPS (Spain), ANSM (France), NICE/MHRA (UK), FIMEA (Finland), NOM (Greece), etc, are public health institutions. And we can trust that states are more concerned about the health of its citizens than about profits.
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PortugueseMan
Posted on: Jun 30 2015, 03:32 AM


Group: Member
Posts: 430

$2.15 USD? What a bargain!
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PortugueseMan
Posted on: Jun 27 2015, 01:22 AM


Group: Member
Posts: 430

The minutes are from the 4th-7th May meeting...
Clunivel was surely informed about the decision on the 7th-8th May... So when CUV says, in that Commercialisation Update from the 5th June, that «The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is scheduled to complete the final review of commitments relating to the distribution of SCENESSE® in September 2015», they are talking about the Post-Authorization Safety Study (PASS) they will resubmit.
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