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Justinian
Posted on: Today, 07:15 AM


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Does Clinuvel have to announce the planned September meeting when If happens? I know some of us were wondering about that back in June, if the meeting happened or not (but obviously didn’t).
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Justinian
Posted on: Aug 6 2019, 01:19 PM


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It seems like a bad drop recently, but to put it in perspective the stock is still higher than it was 3 months ago and quite a bit higher than it was 6 months ago.
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Justinian
Posted on: Aug 5 2019, 10:53 AM


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I'm not super familiar with this stuff, why exactly would shorters make a profit if approval happens?
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Justinian
Posted on: Jul 30 2019, 11:08 AM


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If there's a strong earnings report coming out shortly have we seen the lowest price CUV will ever be?
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Justinian
Posted on: Jul 11 2019, 11:45 AM


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The optimist in me takes the statement as "the FDA is fine with approving it and they are just working out some of the smaller details like CMC and labeling which is why there is a short delay".

The pessimist in me takes the statement as "if the FDA thinks controlling off label use will be too much of a pain in the ass then they will reject the drug".
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Justinian
Posted on: Jul 11 2019, 11:05 AM


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This is the most important part in my opinion:

“However, the benefit-risk assessment reaches much further than as described above, with deliberations on CMC (including manufacturing processes) post-marketing licensing obligations and commitments, product claims, labelling and longer-term use weighing heavily on an agency.”
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Justinian
Posted on: Jul 11 2019, 11:05 AM


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Double post
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Justinian
Posted on: Jul 4 2019, 12:25 PM


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Wouldn't an advisory committee be more useful under exceptional circumstances, where outside expertise could be used to advise the FDA since things aren't so straightforward?

To me it would make sense for the FDA to skip it if they don't have safety/efficacy concerns. Their concerns could just be CMC, as other posters have mentioned previously.
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Justinian
Posted on: Jun 27 2019, 08:45 AM


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That makes more sense.

With the exceptional circumstances bit, I would hope that the 4-5 years of exceptional safety data and proof of effectivity through continued use would make up the difference between that and a regular approval.

Hopefully you’re right about the CMC stuff. If that is indeed the case with switching manufacturers, I assume it’s not something that can be done as easily after approval? Otherwise it seems like Clinuvel picked a bad time to do that.
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Justinian
Posted on: Jun 27 2019, 03:20 AM


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QUOTE
On my list of reasons are:
-Clinuvel is learning the regulatory process as they go. It's slower and error prone, but much cheaper
-Manufacturing and CMC for new, novel technologies is more difficult and the additional challenges can delay approval. In this case, the contract manufacturer's facility has never produced an FDA approved drug. Scenesse will be the first, but it has a learning curve.

I guess what frustrates me is that Clinuvel already went through this with the EMA. If the EMA and FDA are that much different, why? Are the differences just red tape?

Evonik is the manufacturer right. It appears they are a pretty big company, I guess just with no experience with US FDA policies or maybe with healthcare in general?
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Justinian
Posted on: Jun 25 2019, 09:59 AM


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I'm optimistic for this too. It sounds like there will probably be labeling feedback first which we would hear about.

I know at my job if we miss a deadline we usually add in a buffer (to account for unknown issues) for the new deadline we tell management because of how bad it looks to miss a second deadline.
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Justinian
Posted on: Jun 22 2019, 03:45 AM


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I'm not super worried even if JAK inhibitors turn out to be some miracle treatment. I've always thought that going for several other orphan indications first to add to EPP would be a decent business move, and eventually the real end game would be skin cancer prevention. Also, JAK inhibitors are a long ways away from being a commercial product.

On a side note, JAK inhibitors are also being researched for hair loss.
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Justinian
Posted on: Jun 20 2019, 08:22 AM


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I'm pretty sure the sunscreens being banned are just the "chemical" ones like Oxybenzone. The "physical" ones like titanium dioxide don't harm the environment or get absorbed by the body as easily.
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Justinian
Posted on: Jun 11 2019, 02:03 AM


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I guess you're right about the term since there are other benefits, a better slogan would just focus on more generic sun safety. I had mentioned before I was vitamin D deficient after taking a dermatologist recommendation to use sunscreen everyday. In addition to vitamin D, there are cardiovascular benefits to UV exposure independent of vitamin D https://www.ncbi.nlm.nih.gov/pubmed/26766556. For people like me, I would love to get those benefits while also having the ability to protect myself from UV exposure since I was born with a pretty poor protection mechanism.
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Justinian
Posted on: Jun 10 2019, 02:28 PM


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I’m the context of “safe tan” from UV exposure it makes sense that it’s all dangerous. You only tan once you get DNA damage and then alpha MSH is released to trigger the tan and possibly DNA repair also (this part isn’t as clear). Of course some people have that ability much better than others depending on their MC1R function. Luckily Scenesse can bypass the DNA damage part and works well for basically all people (at least from photos I had seen of the black market stuff).
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Justinian
Posted on: Jun 7 2019, 12:19 PM


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The re-balance itself occurs on the third Friday. One week before is the announcement, so the 14th. It's one week before always except in September it's two weeks before.

https://www.marketindex.com.au/rebalance-announcements
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Justinian
Posted on: Jun 7 2019, 09:06 AM


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I was just pointing out how weird the markets are for these stocks.
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Justinian
Posted on: Jun 7 2019, 03:45 AM


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PTN is down 6% today. And meanwhile over the last few days CUV partially rebounded from the drop after the delay announcement. I guess after 3 days the 3 month delay doesn’t mean as much?
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Justinian
Posted on: Jun 6 2019, 07:52 AM


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Clinuvel is definitely cryptic, I won't argue that. But I can't think of any instances where they have said actual misleading information. That may become apparently after the FDA makes a decision and more information is released, though.

Clinuvel did say the FDA needs more time to evaluate basically, and that Clinuvel is answering questions around the clock. Perhaps there aren't concrete issues like with PTN and the blood pressure study being requested. I'm beginning to think maybe it's just a lot of little things such as a minor CMC issue here, a minor post-approval safety study issue there, mixed in with random questions about Scenesse and EPP itself. It would make sense to not release 10 pages of the back and forth with the FDA in that scenario.
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Justinian
Posted on: Jun 5 2019, 10:45 AM


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What exactly would the FDA have issues with for the Nasdaq listing? Seems like pretty standard procedure by Clinuvel to pursue that.
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Justinian
Posted on: Jun 5 2019, 04:36 AM


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The first two are kind of fixable, just much tougher. It would involve more trials or some PASS data modifications or analysis.

I’m just wondering what is so different about the CMC regulations between Europe and USA. It appears there haven’t been any issues in Europe over the last 5+ years.
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Justinian
Posted on: Jun 4 2019, 06:42 AM


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Good finding, I definitely want to go through these.
That's surprising that Keytruda was delayed. It has had a huge impact for the treatment of Melanoma, which of course is related to UV and Scenesse. It is also helpful for other cancers too.
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Justinian
Posted on: Jun 4 2019, 06:39 AM


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Nope. It does seem unusual and that this always happens is frustrating. It's just without more details we don't know if Clinuvel did anything wrong. For all we know the FDA could have just made some BS excuse that they didn't have enough EPP experts and need to learn more about EPP or something.
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Justinian
Posted on: Jun 4 2019, 04:53 AM


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Did anything say that this was a problem with the application and not just the FDA having limited resources or being slow?
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Justinian
Posted on: May 29 2019, 11:26 AM


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For those with a lot of shares there may also be increased dividends post approval. Enough to reward yourself a little bit while still holding onto your shares hopefully.
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Justinian
Posted on: May 29 2019, 03:55 AM


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Bremelanotide phase 3 trial lasted 32 weeks in 700 patients. Scenesse has been tested in hundreds of patients now for years. While it hasn't been tested in in the same number of patients (700+) for several years or more, from my semi-limited experience with a few different drug types this type of safety data is way more than normal at the time of approval.

What do you mean by CMC?
https://clinicaltrials.gov/ct2/show/NCT02338960
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Justinian
Posted on: May 27 2019, 11:50 AM


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Any idea what the hometown team is valued at?
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Justinian
Posted on: May 20 2019, 05:22 AM


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I forgot to mention that if you're trying to be safe long-term and not just avoid sunburns it would still be a good idea to put on sunscreen in addition to some Scenesse like treatment at least when out for extended periods of time though.
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Justinian
Posted on: May 20 2019, 03:17 AM


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These are good questions. A lot of them probably don't have good answers until testing is done and Clinuvel sees what the compounds can do. One thing I will say is that the goal is probably for the topicals to not be systemic, and to only work where applied in order to minimize risk of side effects until larger/longer term studies are done on safety of Scenesse. But I could be wrong here.

The advantage for sun protection is that the protection provided by melanin is longer lasting. Missing a spot is less of a worry when applying once a day at most, as opposed to multiple times in the sun while at the beach, etc. And water can wash off sunscreen. Plus, sunscreens don't block all UV rays. SPF is just the amount of time you can stay in the sun without burning as opposed to normal, SPF 15 is 15 times as long.

Look into Zalfa Abdel-Malek, who does a lot of research on Alpha MSH and topicals. There are other pathways that Alpha MSH analogs can help in addition to just photo protection. Having working MC1R (light skinned people have partial loss of this) means you get more DNA damage, but when alpha MSH stimulates MC1R it supposedly can repair UV damage in addition to just preventing it in the first place with a tan/melanin. https://www.ncbi.nlm.nih.gov/pubmed/19558415
In addition, people with more pheomelanin are more prone to skin cancer even WITHOUT any UV exposure. Increasing the melanin ratio could be beneficial even if no UV exposure is involved. So the regulatory agencies warnings to only avoid UV and apply sunscreen really don't mean everything is perfect for these people who are at highest risk. https://www.nature.com/news/redhead-pigment...er-risk-1.11711

The big hurdle for topicals is penetration and getting it absorbed into the skin. A few researchers have been trying to accomplish this for years. This is what I'm skeptical about.
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Justinian
Posted on: May 13 2019, 10:58 AM


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You jinxed it in the wrong direction!
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Justinian
Posted on: May 10 2019, 12:04 AM


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That’s about what I see. I could see it dipping lower temporarily. And going higher if ASX200 happens and progress on other indications is reported.
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Justinian
Posted on: May 8 2019, 07:49 AM


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I am a skin type 1 living in a high UV environment. My dermatologist told me to use sunscreen every day, so I did. Then later I got blood tests and was vitamin D deficient. Vitamin D is very important for your body. So I started supplementing and it went up a little. Then I doubled the dose and stopped wearing sunscreen when only going to be outside for a very short amount of time, and now my levels are very good.
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Justinian
Posted on: May 3 2019, 06:04 AM


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I'd have to re-read it, but did PW actually mention the odds? I recall him saying 50% of the FDA's decision is based on safety, 50% on efficacy. But I don't remember seeing anything about the odds of approval.
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Justinian
Posted on: May 2 2019, 01:07 PM


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The newsletter basically answered one of my questions from a few days ago about rejection. It seems that as long as safety keeps holding up, a rejection would likely just be a delay. There would be an opportunity to prove that Scenesse is effective still and the rejection would very realistically just be a delay.
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Justinian
Posted on: Apr 30 2019, 02:49 PM


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I've never followed specific stocks too closely besides this one. Does this basically just go away once there is higher volume and shorting can't drive the price as much? Are other ASX300 stocks impacted by this too?
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Justinian
Posted on: Apr 30 2019, 10:48 AM


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The stock is trading down right now. Were people expecting double receipts or something!?
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Justinian
Posted on: Apr 27 2019, 02:56 PM


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What really is the "worst-case" scenario? At this point is there any chance the FDA denies it, or would they just recommend more evidence or something like that? And even if it got flat out denied, other countries could still lead to growth while attempting to secure a different indication in the USA. I would think there would be a decent drop in SP but there could still be long term growth, just several years away again.
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Justinian
Posted on: Apr 20 2019, 02:58 PM


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Receipts from customers in the Jan 31th, 2019 report was 2,608. October 31st 2018 was 10,705. July 30th 2018 was 10,388. April 30th, 2018 report was 3,480.

So even after more customers being served since the 1Q 2018 timeframe, the most recent quarter (4Q 2018) was still the smallest in the last year. I think the fact that the customers purchase the implants ahead of time offsets the fact that there is a delay in reporting.
https://www.clinuvel.com/investors/news/announcements for reference
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Justinian
Posted on: Apr 20 2019, 01:16 PM


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I'm mad at myself for buying for the last time probably a few weeks ago. April 30th is supposed to be the next quarterly financial report. This should have a significant increase since it will be the beginning of the in-demand season and there have been hints that more countries in Europe are online. I'm guessing this will be the lowest the stock will be ever, unless it dips more between now and April 30th.

Even if the FDA had issues, I can't imagine it being worse than "give us more data" with a delay. And there would be other profits coming in from other countries which would bump up the stock price in this scenario and a probable ASX200 inclusion would also bump the price by the time the FDA reaches a decision.
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Justinian
Posted on: Apr 4 2019, 03:26 PM


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I don’t think they ever released the results did they? I’ve always wanted to see those. My guess is there wasn’t any statistically significant finding due to sample size but that’s just a wild guess.
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Justinian
Posted on: Mar 27 2019, 10:44 AM


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I probably would have bought a little more on one of these dips but my normal brokerage fee + the foreign transaction fee turned me off since it would have been a fairly small amount of shares. My friend may have bought some using one of the zero transaction fee apps, but didn't since those pretty much only have the US listed stocks. Both would not have been large transactions, but if there are tons of people in this scenario it could add up.
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Justinian
Posted on: Mar 22 2019, 03:38 PM


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It really would make sense if that is the case, in order to maybe get the treatment to patients this summer.
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Justinian
Posted on: Mar 19 2019, 02:56 PM


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On a completely random note does anyone know anything about when the next dividend might be?
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Justinian
Posted on: Jan 25 2019, 03:06 AM


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Google image search for Scenesse tan has some images from old trials. That should not be the focus until safety has been proven for more years though.
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Justinian
Posted on: Jan 24 2019, 04:47 AM


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I looked up some similar examples, Twitter rose 5% simply upon the announcement that it would be included in the S&P 500.
https://www.investopedia.com/news/twitter-s...-500-inclusion/
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Justinian
Posted on: Jan 20 2019, 03:21 AM


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It’s basiclaly impossible to control for off label use of a pill also.
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Justinian
Posted on: Dec 20 2018, 03:24 AM


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Does anyone know how long the CUV103 trial lasted? The big news to me is the maintenance of pigmentation at day 280, three months after the last dose. I'd imagine the increase in pigmentation on the rest of the skin would return to normal by around that time. What I wonder is if three months is the last time the trial would have checked, or if perhaps the pigmentation would be maintained for longer. Also, if the maintenance is long term I wonder if multiple treatments would have a cumulative effect. Either way three+ months of pigmentation after dosing along with the good statistical numbers and P values that we all know the regulatory agencies like, this is basically a guaranteed approval pending safety issues that pop up.
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Justinian
Posted on: Nov 22 2018, 02:29 PM


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I have no idea if this is true but that's a funny guess
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Justinian
Posted on: Nov 22 2018, 02:29 PM


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The confirmation about patient numbers is very interesting. 4-5k each in USA/Europe seems very promising. Some websites list the "1 in however many" incidence and it comes out less than that sometimes.
I wonder if the terminally ill patient use would be for patients with current indications that are terminally ill with another disease, or if there is new high-impact indication that Scenesse could have value in.
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Justinian
Posted on: Nov 21 2018, 01:27 PM


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QUOTE
The FDA has already stated that Scenesse does not cause cancer. UV light causes skin cancer. Looking back at what dermatologist where saying more than a decade ago their argument against afamelanotide was that it could cause moles to become cancerous. Dermatologists are no longer using that false storyline and in fact, dermatology in the UK is now saying Scenesse should be funded for the treatment of EPP. The NICE disagreement is with the Scenesse pricing. No gripe whatsoever about Dr Wally’s fake tanning issue.

Going back to this, the AGM presentation pointed out why people use to think that Scenesse could cause skin cancer. It says Scenesse darkens moles and freckles, and unusually dark moles can be cancer. But it also depends on irregularity, size, border, shape, etc. This is probably a regulatory concern because it could impact diagnosis if the moles are indeed darkening, even though it isn't causing cancer. The increased melanin could actually prevent the mole from becoming cancerous.
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Justinian
Posted on: Nov 20 2018, 01:16 AM


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DNA damage triggers the body to release alpha MSH in order to repair the damage and tan the skin to prevent future damage. Scenesse is doing what alpha MSH does without the DNA damage part.
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Justinian
Posted on: Nov 9 2018, 03:32 AM


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I’m not entirely sure.

But what about if the FDA said submit it anyways, that they’ll start reviewing what they can, and then later on submit safety data from Europe that wasn’t currently available at the time of the original submission.
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Justinian
Posted on: Nov 9 2018, 01:58 AM


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To me it’s pretty clear there was no RTF even before the latest announcement.

https://www.clinuvel.com/investors/news/ite...6-us-fda-update

“The latest FDA documentation request represents a further step in the review of the submission, which was made under “rolling review” of the NDA.“

Rolling review:
https://www.fda.gov/forpatients/approvals/fast/ucm405399.htm

“Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA”
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Justinian
Posted on: Nov 2 2018, 01:16 AM


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I used to read a bunch of forums of people using street versions of afamelanotide (scenesse), melanotan 2 (similar compound to afamelanotide), and bremanelanotide. The consensus there was that bremanelanotide does not trigger melanogensis or if it does it is very little.
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Justinian
Posted on: Nov 1 2018, 05:37 AM


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Clinuvel’s announcement about the FDA submission from September 5th specifies it was made under “rolling review”. Rolling review means the fda can begin looking at all the other modules which were deemed complete before the problem modules are re-submitted. This may mean the final decision date isn’t actually affected. Although I don’t totally understand.
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Justinian
Posted on: Oct 25 2018, 01:11 PM


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The one thing that worries me a little bit is does Clinuvel really have a monopoly on the market for a long period of time? The original patents aren't for too much longer. But I don't know how additional indications work and also the fact that there is the patient registries and other stuff.
Worst case, it just means a price drop. I was reading that it's from like 25-50% price decrease for drugs once generics hit the market. Although it is always possible some new game changing drug is developed. But it almost certainly wouldn't cover every indication Scenesse does.
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Justinian
Posted on: Oct 20 2018, 04:25 AM


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There was a "phase II open-label pilot study". If I recall correctly, it was initiated by physicians and not Clinuvel.
"afamelanotide 16 mg was administered subcutaneously as a sustained-release resorbable implant formulation to two patients with HHD, who had a number of long-standing skin lesions. For both patients, their scores on the Short Form-36 improved 30 days after the first injection of afamelanotide, and both had 100% clearance of HHD lesions 60 days after the first injection, independently of the lesion location."
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4255790/
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Justinian
Posted on: Oct 18 2018, 11:15 AM


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I wonder if there are differences between Europe and USA manufacturing standards. I’m way too lazy to research it though.
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Justinian
Posted on: Oct 11 2018, 01:14 AM


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Committee rejects drug due to cost, which leads to appeals and possibly judicial trials and more costs. What a world we live in.
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Justinian
Posted on: Oct 5 2018, 02:15 AM


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I think he was saying that the lotion could be applied anywhere and would work systematically. It’s just a way to avoid implants. CUV 9900 would be the topical that works locally.
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Justinian
Posted on: Oct 4 2018, 01:37 PM


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Thank for that info, I wasn't sure if they had focused UV or not.
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Justinian
Posted on: Oct 4 2018, 09:51 AM


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I’m the photos from trials it appears all areas darken, but the depigmented areas darken much faster.
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Justinian
Posted on: Oct 4 2018, 08:43 AM


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I think they’ve hinted at Scenesse implants being used for Vitiligo to repigment affected areas, and then a topical used as a follow on maintenance long term.
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Justinian
Posted on: Oct 3 2018, 01:33 PM


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This trial has got to just be for management to decide if further trials are worth the resources. If it's not obvious that it's effective with an extremely small sample size, then it's not worth the resources for a Phase 2b and 3. If it is effective, they probably know that this trial alone will mean almost nothing to regulators.
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Justinian
Posted on: Oct 2 2018, 12:14 AM


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According to Wikipedia, not everyone with VP has sunlight sensitivity.
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Justinian
Posted on: Oct 1 2018, 10:46 AM


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Seems like one that will be easy to see if it works or not since there are observable blisters. This is a 2a trial, so it might be a while before this indication would be fully approved unless there is some special way it could be allowed through off label use given that porphyria centers may treat these patients.
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Justinian
Posted on: Sep 21 2018, 03:20 AM


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Good catch, that’s something I had been wondering about.
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Justinian
Posted on: Sep 19 2018, 10:00 AM


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Anyone know why CLVLY volume recently has been much higher than CLVLF? In the past they seemed to be relatively close.
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Justinian
Posted on: Sep 10 2018, 11:42 AM


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I'd imagine it would be, but that's just me guessing. It depends on if the FDA is going to treat Vitiligo as opening the floodgates for off-label use or not, but I'm getting the impression that is the case. It would be much more difficult to control distribution at that point. I don't know if the USA will limit distribution with a study and by only allowing it to be given at specialist centers. But if that is the case, I'd imagine getting approval for other orphan indications would be much easier. Smaller studies would be required, also.
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Justinian
Posted on: Sep 10 2018, 11:15 AM


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Very interesting... it mentions a second indication, that they've hinted at before. It says Q4 2018 annnouncement and it has it listed before Vitiligo (page 5). Says photoprotection, DNA repair. Perhaps Xeroderma pigmentosum? I'm glad to hear this though, since early studies in some other rare diseases looked very promising (Hailey Hailey disease).
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Justinian
Posted on: Sep 5 2018, 11:46 AM


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I'll cut the EMA a little slack since there wasn't all the post-approval safety data available that there is now.
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Justinian
Posted on: Sep 5 2018, 11:12 AM


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For all we know the FDA could have been saying it looked good all along then pulled this out of their ass. Which is why it would be nice to see the details, although we definitely wouldn't get them until after the regulatory decision has been made, if ever.
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Justinian
Posted on: Sep 5 2018, 10:25 AM


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I really wish we could know the details of what was requested by the FDA with those modules.
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Justinian
Posted on: Sep 4 2018, 02:11 PM


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I skimmed through this, and it seems like Clinuvel has to disclose the decision, and it has to be "as quickly as you can". There is no formal definition of how quickly.

https://www.asx.com.au/documents/about/abri...-clean-copy.pdf
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Justinian
Posted on: Aug 31 2018, 11:58 AM


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Double that $14 to account for opportunity cost compared to an index fund over 10 years. Then multiple it by some additional number to account for the risk of the scenario where the drug doesn't get approval (very high back then).
But you (and Clinuvel) are obviously just a greedy investor charging insurance companies too much for Scenesse.
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Justinian
Posted on: Aug 31 2018, 10:44 AM


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Unless the trial is starting tomorrow, I'm not so sure they'll need a capital raise. I'm too lazy to look up the cash Clinuvel has but I recall it being a decent amount and the average dermatology Phase 3 cost is 11-12 million https://www.centerpointclinicalservices.com...cost-breakdown/

I guess they might have other large expenses shortly with distribution ramping up, and other trials beginning (hopefully).
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Justinian
Posted on: Aug 29 2018, 03:29 AM


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CUV had decent volume yesterday and went up .82. Not sure if it was all at the end of the day though.
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Justinian
Posted on: Aug 21 2018, 11:59 AM


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Wouldn't every patient get 2 implants between May and August? I assume one every 2 months or so starting in Spring. That would mean 1400 patients.
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Justinian
Posted on: Aug 4 2018, 02:00 AM


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So the time spent outdoors was the same as non-EPP people and that’s not good enough?

Sounds like what they want is some ridiculously specific, cherry picked metric that has a higher p value. Makes no sense to me.
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Justinian
Posted on: Jul 29 2018, 02:13 AM


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The reason it's not a topical is molecule size and potency. CUV9900 and the University of Cincinnati researchers' ones are smaller and more potent. If a topical Scenesse worked, it would almost certainly be due to systemic effects unless there is some new formulation that allows better penetration. Some companies do research this stuff for other purposes.

I'm guessing the cosmetic approval thing is just some generic paperwork that needs to be submitted to make sure you can legally market/sell a product. In the FDA there are various levels of "clearance" like this for devices and I think for regular products too. I'd hope that management didn't expect something to require the full trial route, but it actually does. Any topical Afamelanotide or CUV9900 would need trials in the USA (not sure about Asia and other marketes), perhaps if it's Afamelanotide it would be quicker though.

I'm really hoping that the 24 month approval window is just a worst case scenario in the event that the FDA requires more data from the Europe post-approval monitoring. As mentioned in the newsletter which confirmed what I thought, Scenesse has been proven safe in patients for a way longer period of time than most orphan drugs. Usually it's 1-2 years in a phase 3 trial and that's it. Scenesse has been used for something around 10 years by some people with no significant adverse effects.
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Justinian
Posted on: Jun 26 2018, 06:40 AM


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It seems like there’s a larger issue at play when the main risk for not getting approval is that there is nothing in place by the government to prevent off label prescriptions for tanning by doctors. This shouldn’t be Clinuvel’s problem. It’s like not approving a cancer drug that gets you high because some doctors might give it to abusers.
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Justinian
Posted on: Jun 22 2018, 12:41 PM


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Trading halt is because of a new FDA policy allowing instant approval, and the FDA figured a memorable way to start it would be by approving a sun protection drug on the summer *solstice* when the sun is strongest.
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Justinian
Posted on: Apr 3 2018, 01:27 PM


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He brings up legitimate counter arguments sometimes and I think it's good for any readers of the boards that aren't familiar with the company to hear answers to them. It would be pretty boring otherwise.
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Justinian
Posted on: Apr 3 2018, 12:18 PM


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To be publicly justified, there has to be a return on investment for initial investors. 1.07^15 = 2.75 which is the opportunity cost of investing in a generic index fund for 15 years. One in 10 drugs in Phase 1 trials get approved (varies by indication), so times 2.75 by 10 = 27.5. So the price of the drug needs to equate to a 27 times higher stock price in order to make your money back on average. Since there is a lot of risk, especially for a new class of drug, the number would probably be higher.

Without this return, there would be no treatment for any orphan diseases unless the government decided to fund the R&D itself.
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Justinian
Posted on: Apr 2 2018, 11:56 AM


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I know he's a troll, but anyways I was not saying to purposely expose them to sunlight such as what the Vitiligo studies do. I meant for them to go about their day to day lives and hopefully see a reduction in skin cancers.
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Justinian
Posted on: Mar 31 2018, 08:34 AM


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If this is indeed the correction indication, it could be a very smart/economical way to prove that Scenesse prevents skin cancer. For normal populations, the incidence is rare enough that you would need a large/lengthy trial to prove this. You also have to deal with people probably being less sun safe if they know they can tan better than before. Although it's not 100% guaranteed that these results would carry over to the general population, it seems likely that it would. Hopefully the science lines up... I know Scenesse is tied to p53 and so is xeroderma pigmentosum.
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Justinian
Posted on: Mar 13 2018, 02:14 AM


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In the USA, I’m pretty positive that all alpha MSH analogies need clinical trials and FDA approval. Alpha MSH itself is fine since it’s the natural hormone, but I highly doubt they got that to work. I’m guessing this product is unrelated.
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Justinian
Posted on: Nov 30 2017, 02:05 PM


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CUV9900 is the new molecule that's supposed to be super potent and have the best efficacy as a topical (shorter molecule than Scenesse/Afamelanotide), but would also require the most strict safety data.

VLRX0001 is also a novel molecule without much info from Clinuvel. It specifies that this is self administered by patients, so it's probably less potent than CUV9900.

It sounds like they also have a new OTC product unless one of the above can be classified as OTC somehow if it is deemed safe enough. This is pure speculation, but I wonder if they are going to try putting alpha-MSH into some topical lotion they have or one they will acquire which they have hinted at. This would be OTC since alpha-MSH is a hormone like Melatonin which you can sell OTC.
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Justinian
Posted on: Nov 4 2017, 05:11 AM


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I believe it's only for quick price changes within a couple of days. I don't know the exact rules.
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Justinian
Posted on: Nov 4 2017, 05:10 AM


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What does this mean for Clinuvel in relation to expanded access? That's seems to be basically what Italy/Switzerland had been doing. To my knowledge, Clinuvel hadn't applied for this in the FDA right? It's probably too late for this to be of any use for EPP, but HHD has been granted orphan status by the FDA so maybe once EPP is approved then expanded access could be used for HHD.
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Justinian
Posted on: Aug 25 2017, 02:46 AM


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Alpha msh increasss during pregnancy. Hence the hyperpigmentation in some women.

https://www.ncbi.nlm.nih.gov/m/pubmed/2549741/
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Justinian
Posted on: Jul 20 2017, 11:26 AM


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Here are reasons I can think of why there isn't much communication. It's probably some combination of these. I'm not saying I necessarily agree with it.

1) They are too busy with current tasks
2) They have no news worth sharing
3) They are waiting for big news that is occurring soon (perhaps just the next financial report?)
4) They simply don't care about releasing news to small investors
5) They don't want to release news in order to not give competitors an edge


What confuses me is how it takes so long to file the FDA submission after having already filed the European one which should be in the same language. Either Clinuvel is really slow at it, or there is way too much bureaucracy.
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Justinian
Posted on: Jul 12 2017, 09:37 AM


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If the topical is composed of the same molecule (Afamelanotide) then there is a chance. If it's a different molecule (CUV 9900) then I don't think that can happen.
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Justinian
Posted on: Jun 17 2017, 03:08 AM


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University of Cincinnati, Zalfa Abdel-Malek. Her compound is basically CUV 9900 but likely more potent. It's just making molecular shorter versions of Alpha MSH, as I understand it.
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Justinian
Posted on: Jun 7 2017, 10:03 AM


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Interesting about the mole darkening and skin looking "dirty". The approval report for Europe (I forget the exact name of it) didn't mention this as being common in the side effect profile. It states that mole darkening happens rarely I believe.
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Justinian
Posted on: Mar 2 2017, 01:10 PM


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And to add to my last post, melanoma (particularly those in young/middle age people) is strongly correlated with sunburns and short periods of intense UV exposure such as getting a week of intense sun on a vacation. Tanning beds fall into this category as I mentioned in the last post. Basal cell and squamous cell skin cancers, which are much more common and easily curable if caught in a reasonable manner, are much more correlated with cumulative UV exposure.
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Justinian
Posted on: Mar 2 2017, 01:02 PM


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It's not just total UV exposure. Tanning beds are a very quick burst of intense UV that the body would never see naturally, and in places of the body at angles that normally don't see it. That can't be good. It's similar to how 2 beers a day for a week is better for you than 14 in a single day each week.
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Justinian
Posted on: Jan 23 2017, 11:12 AM


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Yep that's always a big issue too. Unregulated stuff = bad quality. But this stuff was all Melanotan 2 which is a different chemical (although related) which is much more potent and supposedly crosses the blood brain barrier easier than Scenesse (which is known as Melanotan 1).
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Justinian
Posted on: Jan 23 2017, 08:29 AM


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The muscle breakdown was from injecting 6mg at once the first time the person used it. That's like downing a bottle of vodka without any tolerance. The recommend dose is at most 1mg a day, and a lot of people do way less than that.

https://www.ncbi.nlm.nih.gov/pubmed/23121206

And I'd imagine the freckles/moles are the same as Scenesse. Pre-existing sun damage will show once you start becoming a darker skinned phenotype. Some of the moles may have been barely visible prior to injection. People with darker skin overall have darker moles, so this is not necessarily a bad thing. Also, people with pre-cancer/cancerous moles had been frequent tanning bed users which could likely explain that. I don't know of anything that has proven the melanotan caused the dysplastic changes/melanoma.

https://www.ncbi.nlm.nih.gov/pubmed/24355990
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Justinian
Posted on: Nov 1 2016, 05:10 AM


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Where are you getting $100 million from? Google tells me the average phase 3 cost in dermatology is $20 million USD.
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Justinian
Posted on: Nov 1 2016, 01:06 AM


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Right, but how many people in these lower brackets have investments outside of IRAs? I don't know of many. Lowering capital gains tax helps there rich get richer more than helping the lower-middle class.
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Justinian
Posted on: Oct 31 2016, 11:01 PM


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Do low tax brackets really care about capital gains tax? I would think they would care more about income tax.
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Justinian
Posted on: Sep 27 2016, 11:46 AM


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Any reason why you said $200 million or was that just an over exaggeration? This makes it sound like 15-20 millionish https://qph.ec.quoracdn.net/main-qimg-57962...rt_to_webp=true
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Justinian
Posted on: Sep 16 2016, 11:22 PM


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So is this share price rise just caused by the probable addition of a couple hundred EPP patients in Australia next year or the year after? Anyone else know anything I don't know?
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Justinian
Posted on: Sep 3 2016, 01:59 AM


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Need to focus on why development costs are so high. Average cost for a clinical trial participant is 40k+. Times that by hundreds or thousands per participant and add in a large drug failure rate, and that drives a large price to recuperate costs.
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Justinian
Posted on: Aug 29 2016, 07:31 AM


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That was referring to the topical products right?
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Justinian
Posted on: Aug 24 2016, 12:54 AM


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Does this just mean that a 4000 share performance right didn't vest because of some milestone not met? I have no idea how to interpret this.
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Justinian
Posted on: Aug 22 2016, 02:11 AM


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Radio stations talk about that kind of stuff?
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Justinian
Posted on: Aug 16 2016, 11:39 AM


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It definitely made it sound like the next step is Phase 3 for Vitiligo.
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Justinian
Posted on: Aug 11 2016, 11:06 PM


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They did start doing that CEO Newsletter thing within the last year. Although it's been a few months since we've had one.
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Justinian
Posted on: Jul 15 2016, 01:53 AM


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CUV 9900 is a new molecule with a shorter amino acid chain that will hopefully penetrate the skin easier.

VLRX001 may be what you described, though.
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Justinian
Posted on: Jul 10 2016, 12:46 PM


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That $250 million figure isn't quite accurate, since it doesn't account for risk. If the return only accounted for that, nobody would invest and there would be no drugs unless they were developed by public funds. You have to times the return by something like 10 or more since 90+% of drugs fail to make it to the market.
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Justinian
Posted on: Jul 6 2016, 10:43 AM


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It isn't really right to call Scenesse the Barbie drug. That is Melanotan 2. Scenesse does not give the libido increase and the appetite suppression, which makes up 2/3rds of the "Barbie" part along with a tan.
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Justinian
Posted on: Jul 1 2016, 12:46 PM


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I think the purpose of this trial was simply to figure out the protocol for a Phase 3 trial. They have already done one Phase 2 trial for Vitiligo. And they will have tons of safety data from EPP. They basically need to figure out exactly how to conduct a Phase 3 for Vitiligo that will prove efficacy to minimize risk of not getting statistically significant results (i.e only treat darker skin types).
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Justinian
Posted on: May 28 2016, 01:39 PM


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Kind of.

Bremelanotide is closely related to MT-2 and is being trialed for sexual dysfunction. This binds strongly to non-MC1R receptor(s).

These patents are for PL-8177 which supposedly binds strongly to MC1R. Clinuvel is obviously way ahead with trials and data so far. PL-8177 supposedly has a half life of ~2 hours per http://www.palatin.com/programs/inflammatory-disease/. Afamelanotide/MT-1/Scenesse is ~1 hour. (MT-2 is somewhere in the range of 24-30 hours). So without a slow release implant, PL-8177 will likely require multiple injections a day to try to mimic how the slow release implant works. Perhaps the longer half life will make a difference, but I doubt it will be enough so that multiple injections a day are not required.

Also, on their website they say "Contingent on adequate available funds, we anticipate initiating a first-in-man Phase 1 clinical trial in calendar 2016.". This definitely isn't going anywhere fast without some big pharma partner/takeover.
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Justinian
Posted on: May 21 2016, 04:00 AM


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I'd imagine that for HHD, if they are sure of the dosing protocol, they would just need a Phase 3 that's smaller than normal because of existing safety data. They should just need to prove efficacy.

For other indications, I imagine a a combination Phase 1/2, and then a Phase 3. I guess it depends on how easy it is to determine if it works and the dosing protocol. As far as I know though, you have to do a Phase 3 for the new indications.
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Justinian
Posted on: May 12 2016, 02:26 PM


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Clinuvel did all the trials. And the average cost per patient in a trial is 40k. Also in vitro studies required for approval.
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Justinian
Posted on: May 1 2016, 04:09 AM


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So the patients are paying out of pocket for Scenesse in Italy and Switzerland?
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Justinian
Posted on: Apr 30 2016, 06:57 AM


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Technically the approval was conditional, so we still have to deal with regulators each year I believe. We are just very confident on here about the safety of the drug so it hasn't been discussed much.

Also, we've seen how the mere possibility of tanning affects regulators' decisions. It's in Clinuvel's best interest to be on their good side.
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Justinian
Posted on: Apr 30 2016, 06:54 AM


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Probably the best summary of Clinuvel I've read. I didn't know Clinuvel gave trial participants the drug for free for 2 years after the trial ended. We can't say Clinuvel isn't doing this for the patients.

Does anybody know if the past 1.5 years eats into Clinuvel's 10 years of market exclusivity in Europe? I believe in the USA Clinuvel could apply to get this delay time added, I'm not sure about Europe though.
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Justinian
Posted on: Apr 29 2016, 10:38 AM


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R&D looks to be slightly up too.
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Justinian
Posted on: Apr 18 2016, 04:32 PM


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Vitamin D levels could predict risk of poor cardiovascular health http://www.medicalnewstoday.com/articles/308566.php
"In other words, individuals with low levels of both total vitamin D and bioavailable vitamin D were at greatest risk for heart attack, stroke, heart failure and even cardiovascular death, compared with people whose levels of these vitamins were high."

Cancer risk falls with higher levels of vitamin D http://www.medicalnewstoday.com/articles/308834.php
"Vitamin D level of 40 ng/ml or higher tied to 67% lower cancer risk" "The study included all invasive cancers, excluding skin cancer."
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Justinian
Posted on: Apr 4 2016, 01:31 PM


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I agree with Farma that the rare disease act won't mean anything for Vitiligo because it isn't "rare". Possibly for other Orphan diseases - but then the definition of targeted comes into play. Scenesse works by targeting the MC1R receptor - but I don't know if MC1R mutations qualify as targeting a specific gene.

I don't think any of these new regulations that may be approved will be much help for Clinuvel. The 21st Century Cures act would have been very helpful for EPP since regulators could have used the patient voice for justifying efficacy instead of just the numbers. If that was passed two years ago then Scenesse for EPP in the USA probably would have been approved immediately.
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Justinian
Posted on: Mar 27 2016, 07:40 AM


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The problem is Clinuvel hasn't proven that the drug can prevent melanoma yet. It's always possible some unknown pathway encourages melanoma growth, even though most in-vitro science points to Afamelanotide preventing skin cancer.

Proving it is easier said than done. A trial will need to be lengthy and have a large number of participants. And the absence of a true placebo group could pose a problem just like it was for EPP. People on the drug will know they got the drug because they are tan, and thus they might go in the sun more without protection since they will burn less.

Hopefully the results of the AK trial for organ transplant recipients will be released soon, but my gut is telling me the trial will have been too small to get statistically significant results.

If Clinuvel can prove that Scenesse prevents skin cancer, then a tan induced by Scenesse can be seen as more than cosmetic only which will open up a world of possibilities for Clinuvel.
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Justinian
Posted on: Mar 26 2016, 08:27 AM


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Even if the other trials are discarded for Vitiligo, the post authorization safety study in Europe will provide more than enough valid long term safety data. That means for Vitiligo all that needs to be done is confirm dosing/protocol in a possible phase 2, and then a phase 3 for efficacy that I would think could be smaller than a normal phase 3 for a non-orphan drug.
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Justinian
Posted on: Mar 23 2016, 03:23 PM


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It appears the price is going up because of
a) No news at all, except some rumors about implant price
b) News that is not public.

I wonder which it is?
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Justinian
Posted on: Mar 22 2016, 09:09 AM


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The long term monitoring of the drug is in my opinion reasonable and will be very useful, even though it is an additional cost. The delays because of the off label prevention is not reasonable at all, and recent meetings minutes and news releases indicate that this half of the PASS is what caused the delays. It's only going to be distributed at accredited porphyria centers, so what more is necessary? Also, going as far, as one user posted earlier (assuming his German translation was correct), as asking if Scenesse affected the choice of life partner is crazy.
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Justinian
Posted on: Mar 22 2016, 08:36 AM


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Clinuvel increasing the price should not be compared to Shrkeli. Shkreli hiked the price on an already approved generic drug and used a legal loophole to get market exclusivity for a period of time. Clinuvel is asking for a high price to recoup development costs so that it is worthwhile to develop the drug at all, otherwise companies would have no incentive and Scenesse wouldn't exist at all. I feel bad because patients would have probably had the drug two years ago if off label use wasn't such a big concern.
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Justinian
Posted on: Mar 21 2016, 11:16 AM


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Costs to the manufacturer are factored in to the negotiations too. A year and a half of delays and very rigorous post approval requirements should bump up the price some.
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Justinian
Posted on: Feb 18 2016, 11:33 PM


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Don't forget HHD too. It has orphan designation in the USA and Europe also. Clinuvel says the worldwide prevalence is 1:50,000 http://www.clinuvel.com/en/scenesse/hailey-hailey-disease.

I'm very interested in the physician led phase 2 study for it. Hopefully we hear the results this year. The 2 patients that received it in the first trial supposedly had amazing results.
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Justinian
Posted on: Feb 9 2016, 10:55 AM


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With that quote and the recent reports about how the off-label use is what caused the EPAR delays, it's become apparent that the fear of off label use is delaying EPP patients from getting access to the drug. Whether the regulators are being too strict, or Clinuvel not strict enough, one thing is apparent: the regulators don't trust doctors to determine when the drug will benefit a patient. An implant has to be administered by a doctor, this isn't the same as a pill.
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Justinian
Posted on: Feb 5 2016, 11:13 PM


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I googled business loans for pharma companies a while back. Most were pretty vague, but I found one that specified some stuff (I can't remember the name) - for pharma/bio-tech companies it required the companies to have $10 million USD in revenue in the last year at least. Pharma/bio-tech are considered extremely risky to loan to, so the requirements are very strict. Clinuvel will exceed this after full EU rollout, so maybe this will be an option for funding Vitiligo Phase 3, but it isn't an option if they need cash soon it appears.
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Justinian
Posted on: Feb 4 2016, 10:55 AM


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In my opinion the general summary of the delays is either what you said, or another battle in the off-label use war since it seems to be focused about that section of the submission. I bet Clinuvel wants to design the registries so that patients with say HHD could be prescribed the disease by a doctor, but the PRAC isn't having it.
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Justinian
Posted on: Feb 2 2016, 11:06 PM


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That would actually be pretty good news.. from past reports it sounded like they needed a US Phase 2 and then a couple of concurrent trials.

Wpw, you have to remember that there have been many trials AND there will be Europe safety data by the time Clinuvel submits for approval for Vitiligo. That should be plenty of safety data when compared to other drugs.
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Justinian
Posted on: Feb 2 2016, 03:44 AM


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It appears Clinuvel isn't involved at all in negotiations in the UK then. NICE consults patients, doctors, and others, and then sets the price.

Edit: just re-read it and it says that Clinuvel is "discussing" the funding with NICE.
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Justinian
Posted on: Jan 28 2016, 11:58 PM


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I think the cash won't be a big issue if they start selling implants this Spring. The only big expense within the next year looks to be a Vitiligo Phase 2 which they should be able to afford. The ongoing costs and topical R&D aren't huge expenses. They might run into an issue depending on how big the Vitiligo Phase 3 needs to be - but they should have lots of incoming revenue by that time.

The issue is if they don't sell any implants in the EU until 2017. If that actually ends up happening, the question I would be more concerned about is why don't patients have access to a drug two years after approval? Let's hope that doesn't happen and they get these reimbursement negotiations taken care of quickly since it appears they have the full green light from the EMA now. FDA early access would be icing on the cake.
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Justinian
Posted on: Jan 27 2016, 01:05 AM


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The noise in the USA is all the APF and not part of any plan by Clinuvel.
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Justinian
Posted on: Jan 24 2016, 05:10 AM


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Not to say you are a plant (as I think you post mostly reasonable stuff), or that Martin Shkreli has contributed to any posting here, but here is the deal with Martin Shkreli.

https://www.washingtonpost.com/business/eco...4e23_story.html

"Long before the world learned what Daraprim was, biotech investors already knew Shkreli from the sometimes vocal role he played on investor message boards when he tried to short stocks, betting that their prices would fall."

And here is a screenshot from a recent webcast of his:

http://i.imgsafe.org/5e33e15.png

Clinuvel is right there on the top of the list after Retrophin. And we all know he knows of Clinuvel through Retrophin too.

It's not unreasonable to suspect that he posts here.
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Justinian
Posted on: Jan 21 2016, 01:51 AM


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To get the same effect as a single 16mg Scenesse implant, you'd have to inject much more total quantity of the drug likely more than once a day. The slow release implant is actually pretty key intellectual property.

And also, in regards to Vitiligo pictures, let's not forget that Scenesse is supposed to speed repigmentation up so that less UV sessions are needed to get the same effect. This UV is fairly harmful since its on areas with low melanin.
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Justinian
Posted on: Jan 20 2016, 11:01 AM


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What I got out of it:
1) The EMA post-approval risk plan will (as we know) be used for the FDA for EPP and will provide data for safety when applying for Vitiligo. Perhaps this means they can get away with a smaller than normal Phase 3 for a non-orphan disease (Vitiligo) and focus on a large enough sample to prove efficacy only?
2) They expect the FDA to require a similar post approval plan to the one that the EMA required. This means that off-label use will be minimal if EPP is approved. I don't know what he meant by the "Vitiligo and EPP are intertwined with the FDA" comment now. Maybe they expect the American Porphyria Association to be successful in getting early access for EPP with the FDA and there is a change of plans? Perhaps they were just referring to the risk assessment plan serving as safety data for Vitiligo?
3) They will provide updates on reimbursements and first sales in specific countries via these newsletters.
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Justinian
Posted on: Jan 16 2016, 05:39 AM


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"Strategic move" probably isn't the best word for it, but Clinuvel has to play the waiting game with the FDA so there really wasn't much to say about it. Clinuvel can submit the package for approval once they get the 6 months of EU safety data. If anything happens before then it will be the FDA's initiative for allowing early access, not Clinuvel asking for it.
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Justinian
Posted on: Jan 12 2016, 02:16 PM


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I've been invested for a year and a half now, which was the time when I first heard of Clinuvel. I've read all the recent reports, but don't recall seeing anything related to what actually happened in the early-mid 2000's other than vague references such as what I posted, and also hearsay that people on here post occasionally. I would be interested in any meeting summaries, press releases, etc., related to those matters from way back in the day. I recall seeing some old annual reports but even those weren't too specific on FDA interactions and they focused more on the ongoing/planned trials.
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Justinian
Posted on: Jan 12 2016, 01:51 PM


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This is from the 2014 Clinuvel annual report: "We still have a hard core of mezzanine investors who were initially lured by the idea of a "tanning drug" and invested in Epitan. A disastrous foray to the FDA resulted in strongly worded advice to "back-off" and withdraw because the product would never gain approval."

https://www.google.com/url?sa=t&rct=j&a...JOQ&cad=rja

If those quotes are true then the FDA seriously has some weird issue about people getting a tan for protection/cosmetic benefit. This is just one side of the story though and I can't seem to find any other links to anything else from that time period about this. I'd imagine that's part of it, and another part is that you need something to measure quantitatively for a drug to gain approval, and the FDA said measuring increased melanin isn't acceptable regardless of the safety profile. Clinuvel/Epitan would then have to start a very large and lengthy trial to show the skin protection benefits through cancerous/pre-cancerous lesions, which they never had the resources to do. So they had to be more creative and that's when they settled on EPP and then Vitiligo.
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Justinian
Posted on: Jan 12 2016, 06:31 AM


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I completely agree.

The point I was trying to make is that the side effects for accutane are much more severe, and it was approved and has benefited a great deal of people. If there are any serious/common side effects for Scenesse, it has not been listed in the EMA reports. All I recall being listed are nausea, facial flushing, mild headache, and temporary darkening of moles (because of increased melanin being produced by the skin). If there are other suspected serious safety concerns they have not been communicated by Clinuvel or regulatory agencies.
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Justinian
Posted on: Jan 12 2016, 01:40 AM


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My friend had to get routine blood tests and psychiatric evaluations on it to ensure he didn't have any suicidal thoughts because of it. The only side effect he had was pretty bad foot pain if I remember correctly.
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Justinian
Posted on: Jan 11 2016, 11:28 AM


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1) I seriously thought Ignoramus was trolling with the dentist vs 30 experts for the NEJM post until his follow up reply.
2) The reason there was only 7 minutes extra spent in daylight by EPP patients during the trials has been discussed a million times. It's the whole reason the regulatory agencies are skeptical even though the patients and doctors all say it works. Clinuvel probably takes some blame here for the trial design/measurements.
3) The majority of people in the USA and Australia do not have skin that is capable of tanning to achieve the amount of melanin that the indigenous populations of the areas evolved over thousands of years to get. My skin is perfectly fine... in northern Europe, not way closer to the equator where I and many other people live. I am one of the people that would pay thousands for a safe, effective tanning drug.
4) The fact that some patients have been followed (even if only a couple hundred) for 5+ years before approval is way longer than most drugs that I've seen. Most approved drugs probably have a slightly larger patient count in total than Scenesse (at least until Europe distribution/tracking), but for a way shorter period of time.
5) For acne, the most effective treatment and the one that is needed for people is Accutane. Acne isn't any more serious than most things Scenesse would treat, right? Here's the side effects for Accutane (not including the rare ones):
http://www.drugs.com/sfx/accutane-side-effects.html
You should check with your doctor immediately if any of these side effects occur when taking isotretinoin:

More common
  • Bone or joint pain
  • burning, redness, itching, or other signs of eye inflammation
  • difficulty moving
  • nosebleeds
  • scaling, redness, burning, pain, or other signs of inflammation of the lips
  • skin infection or rash
More common
  • Crusting of the skin
  • difficulty in wearing contact lenses (may continue after medicine is stopped)
  • dryness of the eyes (may continue after treatment is stopped)
  • dryness of the mouth or nose
  • dryness or itching of the skin
  • headache (mild)
  • increased sensitivity of the skin to sunlight
  • peeling of the skin on palms of the hands or soles of the feet
  • stomach upset
  • thinning of the hair (may continue after treatment is stopped)
And here we are worrying about facial flushing and nausea.
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Justinian
Posted on: Dec 31 2015, 03:39 AM


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I actually don't think he's in the minority. I stumbled upon Clinuvel after researching skin cancer prevention. I don't think very many people are invested in Clinuvel here in the USA that do not have some personal interest in Scenesse (whether for themselves or someone they know). Clinuvel simply isn't well known. On a reddit post about sunscreen being bad for the environment a few months back, somebody said "I wish there were a pill that could increase melanin". I of course informed them of Clinuvel, but nobody had any clue they existed.

I think Clinuvel is purposely keeping themselves off the radar until EPP is in the past and they are full force into Vitiligo and/or the topical is in trials.
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Justinian
Posted on: Dec 10 2015, 01:47 AM


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FYI it's Melanotan. Melatonin is a sleeping pill.

It's pretty safe to use Melanotan, but the fact of the matter is that, in the USA at least, it's illegal to sell Melanotan for human consumption. Also it's a slightly different scenario than hair loss drugs. You're right that they are very proactive and try all sorts of experimental. But they are almost all topicals. For EPP, you'd have to inject Melanotan which scares a lot of people off. Also, Melanotan 1, which is the chemical equivalent of Scenesse, has a half life of an hour and needs to be injected often for good results. Clinuvel's slow release implant is very beneficial here. The more popular Melanotan 2 has a longer half life, but has more short term side effects (none that are serious), and the long term side effects are less known.

Also, I've seen some comments about why there are no pictures to serve as proof from the recent trial. Clinuvel mentioned this in the press release: "Images of vitiligo patients have not yet been released due to restrictions in the newly implemented Personal Data Protection Act 2012 (PDPA) in Singapore and its amendment of 2013."
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Justinian
Posted on: Dec 9 2015, 11:09 AM


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The letter is entirely the work of the APF. Clinuvel has nothing to do with it. Are you accusing Clinuvel of bribing them or something?

And I find it funny in the same post you accuse somebody of thinking the NEJM article is a fraud, and then you go on to say that there is no proof of Scenesse being effective.

"Obviously you also believe that the Scenesse data published in the NEJM and reviewed by a bus load of doctors was a fraud."
"Goes without saying I would prefer a drug that has been trailed and proven to be of benefit for the treatment of a particular disease. This has not yet been achieved with Scenesse so now Clinuvel have resorted to encouraging template letter writing by supposed EPP patients. "

Here's a quote straight from the conclusion of that article: "Afamelanotide had an acceptable side-effect and adverse-event profile and was associated with an increased duration of sun exposure without pain and improved quality of life in patients with erythropoietic protoporphyria."

Here are quotes from the authors of the NEJM article:
"The effect of afamelanotide on diminishing these restrictions and on patient quality of life is dramatic – even more dramatic than has been captured by the trial assessment tools – and a great advantage of the drug is that side effects are minimal."

"The trial results show that the afamelanotide treatment transforms the lives of EPP patients, in essence that is the ultimate goal of having a company and academia working on new technology for 10 years,” said Dr Robert J Desnick, Dean for Genetic and Genomic Medicine and Professor and Chairman Emeritus of the Department of Genetics and Genomic Sciences at Mount Sinai School of Medicine, New York, and the corresponding author for the NEJM paper. “I’m optimistic that afamelanotide will be available to US patients in the future and delighted that European patients will soon have access to a much-needed treatment."

"Beyond EPP there is a great deal of potential for afamelanotide and similar melanocortin-based therapies. The immediate and most obvious targets are translationally photosensitive and light-induced disorders where no effective therapeutic options exist."

http://www.clinuvel.com/en/investors/news-...e%C2%AE-studies
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Justinian
Posted on: Dec 7 2015, 09:14 AM


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A drug called Bremelanotide is currently being developed for that purpose. https://en.wikipedia.org/wiki/Bremelanotide

It's very similar structurally to Melanotan 2. It led to high blood pressure, which the regulators basically said no to, so they are re-trying it with a sub-cutaneous implant like Scenesse.

Melanotan 2 / Bremalanotide effect the MC3R and MC4R receptors, which play a role in energy homeostasis and sexual behavior. These are in the brain and are not nearly as well studied as MC1R, which Scenesse is pretty selective for. These should require much more study to become a drug that is considered safe by the medical community. Anybody concerned with long term side effects should definitely use Melanotan-1/Scenesse over Melanotan-2 for sun protection/UV related diseases.
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Justinian
Posted on: Dec 5 2015, 01:40 AM


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To elaborate a little more, I guess in Clinuvel's case for Vitiligo getting approval for a second indication probably won't make things much quicker since usually they just get to skip out on the earlier phase trials and those have already been done. But they can probably get away with the lower end Phase 3 trial size, which should save them a lot of money. They just need to be sure to include enough patients to show efficacy in the data.

"Although first analyses were made on a small number of patients, preliminary statistical analyses (intention to treat population) comparing the change from baseline over time in the Vitiligo Area Scoring Index (VASI2) score (all body surfaces) between the treatment groups showed a positive trend in favour of SCENESSE® (p=0.052 at Day 168;"

For those who know statistics, a P value of .05 or under is generally considered statistically significant and is the goal to prove that the seen results weren't a fluke. The calculation of this value largely depends on sample size. And this trial was so small, the fact that they almost got a P value under .05 means the efficacy must have been extremely good.
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Justinian
Posted on: Dec 5 2015, 01:28 AM


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Getting a drug approved for a second indication is always easier/quicker, since safety has pretty much been proven. By the time they get in any results from the post market EMA study with hundreds or thousands of patients, then they will have more than enough safety data. Then they just need to prove efficacy for Vitiligo in a Phase 3.

"The preliminary observations seen in the CUV103 study are consistent with the previous experience with SCENESSE® in combination with NB-UVB in the CUV102 study conducted in the US, where SCENESSE® combination therapy seems to provide a near complete and progressive repigmentation of skin areas affected."

That's the important line. If that's true, and no big adverse effects show up which probably would have by now, then it's not a matter of if just a matter of when.
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Justinian
Posted on: Dec 2 2015, 03:20 PM


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For the USA at least (not sure about other countries but I think most of them are similar), manufacturing and selling Melanotan is not illegal. Marketing it for human consumption is. All the people buying it are buying it for "research purposes". The distributors that have been shut down were marketing it too much as a tanning aid.

Clinuvel is doing all of this for the right to market Scenesse to humans. Melanotan I is essentially the same, but from reading reports the implant is more effective (than if a comparable amount is injected), it is regulated for product quality, and it is easier to administer since you don't have to inject it every day. Melanotan II is a different molecule which has some different side effects. If someone is concerned about safety, Melanotan II is not a competitor to Scenesse - although it is very effective.

What's annoying is that this is playing out similarly to illegal street drugs. Marijuana is illegal and used by tons of people anyway. It would be safer if it was regulated, the product quality would increase, and profits would go to legitimate sellers. Melanotan is used for tanning by thousands of people around the globe with the primary dangers not being the drug itself, but injecting it using needles and the risk of using a contaminated or impure product. Then news articles come out trying to scare everybody by exaggerating the dangers of Melanotan, when the adverse effects from the stories they report about are caused by improper administration.
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Justinian
Posted on: Nov 26 2015, 12:44 AM


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Could Clinuvel possible get a loan for a trial? I have no idea how business loans work but they would be guaranteed to pay it back with EPP revenue in the worst case (just very slowly). I have no idea if other companies do this or if it's always partnerships.
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Justinian
Posted on: Nov 25 2015, 12:02 PM


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Here is an interesting read that is related to Clinuvel.

"'Orphan drug' loophole needs closing, Johns Hopkins researchers say"

http://www.medicalnewstoday.com/releases/302957.php

"In a commentary published Nov. 19 in the American Journal of Clinical Oncology, the authors argue that pharmaceutical companies are exploiting gaps in the law by claiming "orphan" status--a designation meant to encourage the development of drugs for rare diseases that affect fewer than 200,000 people in the United States. Yet many of these drugs, the authors say, end up being marketed for other, more common conditions, generating billions in profits."

"Makary says companies exploit the law by initially listing only a single indication for a drug's use -- one narrow enough to qualify for "orphan" disease benefits. After FDA approval, however, some such drugs are marketed and used off label far more broadly, thus turning large profits."

"For example, the authors say, the drug rituximab, was originally approved to treat follicular B-cell non-Hodgkin's lymphoma, a disease that affects about 14,000 patients a year. The drug, however, is now also used to treat several other types of cancer, organ rejection following kidney transplantation and autoimmune diseases, including rheumatoid arthritis which affects 1.3 million Americans. Rituximab, marketed under several trade names, is the number-one selling medication approved as an orphan drug, the 12-th all-time drug best seller in the United States and generated $3.7 billion in domestic sales in 2014. In fact, seven of the top 10 best-selling drugs in the United States for 2014 came on the market with an "orphan" designation, the authors say."

"Makary and team recommend that once a drug exceeds the basic tenets of the act -- to treat fewer than 200,000 people -- it should no longer receive government support or marketing exclusivity. This can be achieved, the authors say, through pricing negotiations, clauses that reduced marketing exclusivity and leveling of taxes once a medication becomes a blockbuster treatment for conditions not listed in the original FDA approval. Such measures would ensure that the spirit of the original act is followed while continuing to provide critical economic incentives for truly rare diseases, the authors conclude."
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Justinian
Posted on: Nov 25 2015, 02:04 AM


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So I'm wondering about a couple of things..

Does the "first topical formulation available H2 2016" line mean they will have finalized a chemical formulation to move forward with, that they will start trials then?

And the other thing is, why do they need another U.S. Phase 2 for Vitiligo? Does the Singapore one not apply to the U.S. for some reason? Are very dark skinned Asians really going to have different results that dark skinned Africans in the U.S.? What information would another phase 2 give anybody unless they are changing the dose or adding in the topical product as a combination therapy?
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Justinian
Posted on: Nov 15 2015, 06:48 AM


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Yes, Afamelanotide and Alpha-MSH have been shown to repair DNA damage caused by UV light. Look up Zalfa Abdel-Malek from the University of Cincinnati. Alpha-MSH activates the MC1R receptor which induces tanning, and as she has shown, also induces DNA repair. Fair skinned people that don't tan well have versions of MC1R that isn't stimulated by their natural Alpha-MSH, so they don't tan and don't get DNA repair. Note that this occurs to various degrees and is not all or nothing. Alpha MSH analogues such as Afamelanotide/Scenesse do activate MC1R (even in people where it isn't naturally) which leads to increased pigmentation/increased eumelanin (which prevents DNA damage in the first place) and according to this research also directly increases DNA repair.

People who use Melanotan often report the negative side effect of darkened moles since their #1 concern is cosmetic use. As ignoramus said, darker skinned people don't get as much melanoma but they still have moles. They don't have as many moles on average and if you pay attention, their moles are usually dark brown/black and have a lot of eumelanin to serve as protection. Light skinned people usually have light brown/tan/reddish brown moles which don't have the same level of protection. This darkening of moles has been seen as a negative effect of Afamelanotide in the past, but as research comes out I think this may simply be the body providing increased protection to areas that it knows are already somewhat damaged (by activating more eumelanin synthesis in moles). This can be good since people at low risk of melanoma have very dark moles. The downside is having a very dark mole is a good indicator of melanoma, so this makes giving an accurate diagnosis tougher.
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Justinian
Posted on: Nov 9 2015, 07:51 AM


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Unfortunately I don't think a topical formulation can make it to the market that quickly. The only way that's possible is if it is the Afamelanotide molecule in a topical form. It is a pretty big molecule which is good for limiting side effects, but bad for topical penetration. People have tried Melanotan topically with little to no success. The other, smaller molecules will have to go through the full three phases of trials. It will hopefully be much quicker trialing a topical drug than it has been for the implant, especially considering it should have a similar mechanism of action to the already approved drug. But 2 years is too short barring some special utilization of the 21st Century Cures Act.
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Justinian
Posted on: Nov 3 2015, 11:47 PM


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I know I've seen a ton of experts support EPP, but here's an expert talking about a Vitiligo trial:
"Our findings offer patients with vitiligo worldwide a renewed hope for a bright future in the treatment of this disfiguring disease,” says Henry Lim, M.D., chair of Dermatology at Henry Ford and the study’s lead author."
"Henry Ford dermatologists described the repigmentation results as “superior,” and said the treatment combination holds promise as a future therapy for the more than 50 million people worldwide living with vitiligo."

http://www.henryford.com/body.cfm?id=46335...il&ref=2127
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Justinian
Posted on: Nov 3 2015, 10:58 AM


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Allergan, with a market cap of 124 billion and 42 drugs on their Wikipedia page, has 10,500 followers on Facebook.
Clinuvel has 752 members in the group. That means Allergan should be about 10,500/752 = 14 times as valuable as Clinuvel. 124 billion / 14 = 8.85 billion for Clinuvel's correct market cap. Looks like Clinuvel is a little bit undervalued.

(/sarcasm)
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Justinian
Posted on: Oct 30 2015, 12:03 AM


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I guess misinformation isn't the right word for everything I was talking about. Basically I meant there is a bunch of stuff that is unclear, and some of that is being passed off as fact.

The 21st Century Cures Cures Act actually has a large section about patient feedback being a big part of the approval process. Hopefully that gets finalized soon.
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Justinian
Posted on: Oct 29 2015, 11:23 AM


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Another company supposedly already has http://www.usatoday.com/story/money/2015/1...aprim/74452030/
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Justinian
Posted on: Oct 29 2015, 09:04 AM


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Well it wasn't just negotiating, it was also the post marketing study that the EMA rejected. And I bet if Clinuvel tried to negotiate earlier, insurance companies would just say come back when you have an approved drug. For all we know they could have agreements in place, but it's beyond the time of year for Scenesse to be used in Europe, so they are waiting for the Spring to finalize them. 4 implants spaced 2 months apart probably means Scenesse is implanted in March, May, July, September, or something along those lines.

And yes it isn't life threatening, but EPP can be toxic to the liver. It would have been nice if Clinuvel could prove Scenesse helped in that sense. As a skin type 1 living in a high UV environment, I can sympathize with EPP patients even though my situation isn't even nearly as bad. EPP patients have to be fully clothed on every inch of their skin and sunscreen doesn't help. They basically can't go outside during the day and I've read about patients with extreme cases where they can't even drive to work. Regardless, orphan drugs and orphan drug prices were designed for conditions like EPP. If orphan drugs didn't get a "high" price, no company would ever develop them because they would lose large amounts of money on average.
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Justinian
Posted on: Oct 29 2015, 08:55 AM


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30% are for cancer. But even if Scenesse is priced in the bottom quarter of Orphan Drugs, a price of 4x10,000 or 4x15,000 doesn't seem that unreasonable (4 is the recommended number of implants per year by the EMA). That's 40-60k per patient per year, as compared to the average of $137,782. And that is the median price, so an oncology drug priced at 400k a year doesn't affect it disproportionately. It's really pointless to keep arguing though without knowing the figures Clinuvel is asking for, which we will probably never know.
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Justinian
Posted on: Oct 29 2015, 01:09 AM


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Also, one thing I forgot to mention is that The HHD trial is physician led/sponsored so I don't think Clinuvel is in control of those results.

And also about Clinuvel withholding trial results and it being required to be released since it is market sensitive info... I don't know the rules but I know Allergan completed a study for Bimatoprost for hair loss in January 2015 and still hasn't released the results of it.
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Justinian
Posted on: Oct 29 2015, 01:02 AM


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I recall you downplaying the efficacy of Scenesse to induce tanning a few months ago, in an apparent attempt to make it seem like it has fewer possible uses.
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Justinian
Posted on: Oct 29 2015, 12:50 AM


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I'm seeing a lot of misinformation here and would like to clear it up.

First, it appears that the FDA can restrict Scenesse usage similarly to the EMA. Hopefully the most they do is post marketing studies to monitor adverse reactions (so that other patients who need treatment can get it sooner if they have the money). But I found this too http://www.fda.gov/Drugs/DrugSafety/ucm255005.htm "Healthcare providers and patients must be enrolled in the Avandia-Rosiglitazone Medicines Access Program in order to prescribe and receive rosiglitazone medicines. After November 18, 2011, rosiglitazone medicines will no longer be available through retail pharmacies." This was because of a probable heart attacking risk, though.

Second, the average price per patient for year for orphan drugs was $137,782 per year in 2014. Does Clinuvel's probable asking price for EPP seem so ridiculous considering that? http://info.evaluategroup.com/od2014-lp-cs.html

Also, someone mentioned how Clinuvel doesn't have data and only has patients voices on their side for proof of Scenesse's efficacy. I would argue about the data, but irregardless what about physicians who have come out in support of it and published papers on its efficacy?

Finally, why would Clinuvel need another phase 2 for Vitiligo? The one we are awaiting results for is referred to as Phase 2B. They should only need a large Phase 3 after that. The only reason I can think of for another Phase 2 is if they stop pursuing Scenesse alone for Vitiligo and test it in combination with a topical formulation.
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Justinian
Posted on: Oct 28 2015, 11:31 AM


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The price of a drug isn't primarily related to manufacturing costs. It's mostly research and development costs. And this drug took 20 years to get here. I find it hard to blame Clinuvel because of all the hurdles they had to go through. If it wasnt for the historically long decision for approval then EPP patients would have Scenesse already. And the FDA application would probably be submitted if they didn't need to supplement it with 6 months of safety data. The one thing Clinuvel could have done is bigger trials, but that would have to be for an indication other than EPP because of the rarity of the disease. But they have data for patients on the drug for 5+ years thanks to Italy and Switzerland, which is unusual for drugs yet to be approved. Also they may have slacked on a little bit of pre clinical data in one area if I remember correctly. And while EPP isn't as life threatening as say cancer, everyone seems worried about possible side effects of Scenesse while there are tons of approved drugs for much less serious conditions with more known side effects.
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Justinian
Posted on: Oct 28 2015, 11:31 AM


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Double post
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Justinian
Posted on: Oct 5 2015, 08:37 AM


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So this sounds like (if the FDA approves this recommendation), that Scenesse will be "approved" and could be used for patients starting in the Spring of 2016. But, there will be a Phase 4 study required and if the results aren't good then that approval can be revoked.
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Justinian
Posted on: Oct 5 2015, 06:45 AM


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"Does Scenesse work by tan alone, probably not, but anti-inflammatory and DNA repair properties?"

Zalfa Abdel-Malek at the University of Cincinnati has published many research papers describing the DNA repair properties of Alpha MSH and its analogues. She is working on a topical cream and is the biggest competition to CUV 9900. I'm hoping that her work doesn't get bought by a large pharma company and rushed to the market. Ideally, CUV9900 will work and make it to the market first, or Clinuvel will buy her work. And Clinuvel's patents for Alpha MSH analogues for melanogenesis may provide protection.

Here is a UC news article: http://healthnews.uc.edu/news/?/24818/
"In 2006, UC researchers were given $1 million from the National Cancer Institute to develop a topical treatment that would not only make skin tan but would also work to both block harmful ultraviolet rays (UV) and repair damage caused by sun exposure, which could lead to skin cancer."

"
This truly translational research is working at the cellular level to protect and repair the skin, and to increase pigmentation without sun exposure, which is the desired outcome that reduces UV-induced damage in the first place."

"A
lpha-MSH has also been found to repair precancerous damage that UV rays cause to skin cell DNA, the genetic material within cells, a major discovery in Abdel-Malek’s laboratory."

"
We showed that alpha-MSH repairs DNA damage caused by excessive sun exposure, reversing the cancer-causing effects of UV radiation"

"
Prevention is so important, and the development of a topical cream that could prevent skin cancer by increasing skin pigmentation and repairing DNA damage caused by UV exposure could tremendously reduce the incidence of melanoma and all forms of sun-induced skin cancer."
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Justinian
Posted on: Sep 23 2015, 02:02 PM


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If I was a long term shareholder I'd be pretty frustrated, so I don't blame you. But the management is only to blame for a portion of the delays.
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Justinian
Posted on: Sep 23 2015, 12:41 PM


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The sustained release implant lasts for about ten days. The half life of Afamelanotide is very short, less than an hour http://www.clinuvel.com/en/scenesse/SCENES...nt-drug-product. This means that any non-sustained release delivery would be very time-consuming/difficult to administer.

I have been informed that Clinuvel can also extend the patent by 5 years. It can perform patent restoration which should be approved given the length of time to market http://www.fda.gov/Drugs/DevelopmentApprov...e/ucm069959.htm. It also appears that Clinuvel will have market exclusivity for 7-8 years anyway https://www.lw.com/upload/pubcontent/_pdf/pub2655_1.pdf
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Justinian
Posted on: Sep 22 2015, 01:30 PM


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The sustained release formulation is listed on there as expiring in 2025. I highly doubt anybody brings afamelanotide to the market with injections that must be administered every day. On top of that, it would have to be for a disease other than the rest of the IP, which includes melanogenesis, reducing skin cancer, photodermatoses (EPP and similar disease), and general photoprotection/DNA protection.

The one that seems worrying to me is the topical formulations which is listed as 2024 and hasn't started trials yet. Hopefully they have a plan for getting this extended, as there are ways. I'm not sure what it means by "A period of marketing exclusivity is established in the major marketing jurisdictions globally. This basically affords protection for a period of 7 years in the US and Australia/New Zealand and 6-10 years (plus a further 1 to 3 years for the generic registration process) in Europe" though. Does this mean 7 years in the US starting once the drug is approved?
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Justinian
Posted on: Sep 22 2015, 10:56 AM


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It's definitely longer than that. It will be somewhere in the mid to late 2020's. It's not very simple with this kind of stuff.

Here is what they have patents for.
http://www.clinuvel.com/en/investors/busin...ectual-property
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Justinian
Posted on: Sep 17 2015, 02:20 PM


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I don't necessarily disagree... I'm just saying that in this scenario it's probably not people scrambling around the Clinuvel HQ to get the website fixed. It would be them giving angry phone calls to another company.
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Justinian
Posted on: Sep 17 2015, 12:22 PM


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It's pretty likely that they contract the website out to some other company. It's probably not their fault directly.
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Justinian
Posted on: Sep 16 2015, 03:31 AM


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I don't see Afamelanotide being obsolete for a while. The only similar things in the foreseeable future are all alpha msg analogues which effect more than just MC1R also. And, preliminary research shows some of this non selectivity may be a good thing. The biggest competition are topical formulations of these analgoues, which Clinuvel has their own version of.

This isn't considering patent expiration/generic versions of course.
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Justinian
Posted on: Sep 7 2015, 05:05 AM


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"I never said the implant was complicated, but the procedure to inject it was...meaning an approved doctor at an approved porphyria center. Where is your local porphyria center? This is not an easy access drug. The average GP will not be allowed to administer Scenesse imo because of this restriction the EMA has put on the distribution channels. I believe this is out of the norm for an approved drug."

I'm pretty sure that this restriction is to monitor off-label use, not because of how complex it is to administer the implant.

It does seem to be out of the norm for an approved drug. But, Scenesse is kind of special. Are there any other orphan drugs that have such obvious possibilities for treatment of a number of other diseases? Orphan drugs have relaxed trial requirements (Scenesse phase 3 trials were much smaller than that required for non-orphan drugs). The EMA has decided the risk/reward ratio is good enough for Scenesse to treat EPP, but they haven't decided that yet for other less serious conditions, hence the restriction. I don't know for sure, but it's probably more normal for orphan drugs to be pretty narrow focused on treating the orphan disease and not much else.
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Justinian
Posted on: Sep 4 2015, 05:11 AM


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Unfortunately Scenesse is an analogue of a hormone, while melatonin is a hormone. And everything natural is good for you right?
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Justinian
Posted on: Aug 29 2015, 02:23 AM


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I agree that EPP/HHD/etc. are the way to go at first, but not because of what you said.

Suncreens do prevent skin cancer. This trial showed a reduction in the number of melanomas and in the invasiveness of the melanomas. http://www.ncbi.nlm.nih.gov/pubmed/21135266
There are a number of reasons why the cancer rate is still going up since the introduction of sunscreens: Original sunscreens didn't block UVA. People don't apply enough or re-apply. People stay out in the sun longer than they normally would without sunscreen. Tanning beds. More tropical vacations with sunburns. Ozone layer getting depleted. More people living in higher UV environments than their ancestors (southern USA for example).

And Epitan did prove that melanotan prevents sunburn and tans the skin. Clinuvel just can't advertise this route because the regulators don't like it for whatever reason (which is why Epitan is no longer around). "Tanning in the first study was achieved in 3 of 4 subjects receiving MT-1, and these subjects also had 47% fewer sunburn cells at the irradiated neck site." http://www.ncbi.nlm.nih.gov/pubmed/15262693
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Justinian
Posted on: Aug 28 2015, 09:59 AM


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People with red hair do in fact have a higher risk for melanoma than people with blond hair.

http://jco.ascopubs.org/content/23/12/2669/T2.expansion.html

Relative Risk:
Red:2.05
Blond:1.21
Light Brown: 1.00
Dark Brown: 0.78
Black: 0.60

In fact, people with red hair are at higher risk for melanoma even without any sun exposure:

http://articles.latimes.com/2012/oct/31/sc...lamona-20121101

"Redheads may be at higher risk of melanoma even without sun.
A study on mice suggests that pheomelanin pigment, which gives rise to red hair, is itself a potential trigger for melanoma, the deadliest form of skin cancer."

Red Hair = Pheomelanin
Blonde Hair = Little pheomelanin and little eumelanin
Brown - eumelanin
Black = lots of eunmelanin

While hair color doesn't entirely predict skin melanin content, there is a big correlation.

So theoretically people with red hair can take all of the precautions against melanoma (stay indoors, sunscreen, shade, etc.) and still be at higher risk for melanoma. Scenesse could convert them to produce eumelanin instead of pheomelanin. Then even if they don't get any UV exposure they are theoretically lowering their melanoma risk. Sucks that people with red hair don't have this option to protect themselves.
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Justinian
Posted on: Aug 27 2015, 01:17 PM


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Posts: 229

I doubt it speeds up Vitiligo directly, unless the FDA doesn't monitor the off label use strictly like the EMA is.

What could speed up Vitiligo a lot is the 21st Century Cures Act. I've read a lot of summaries of it, and I still don't know exactly what all it includes particularly because it keeps changing in each draft. But there is stuff in there describing how it will be easier for already approved drugs to be approved for other rare diseases because the FDA will consider more data from trials of the previously approved drug. It also talks about approving drugs for which "unmet medical needs exist" once evidence of efficacy/safety is displayed from early stage clinical trial data (during a phase 3 trial or earlier?). It describes the FDA accepting alternative statistical methods and patient experience data, which means EPP could definitely be approved as it is with the current data. There is another about extending the market exclusivity by 6 months for each additional rare disease the drug gets approval for. There are several rare light related disease Clinuvel could take advantage of here. Basically, a lot of good stuff for Clinuvel. They have to know about all this, but they can't talk about it because the bill hasn't officially passed yet.

Here is a good summary of the act that I found: http://www.fdalawblog.net/Cures-Discussion...-by-Section.pdf
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Justinian
Posted on: Aug 27 2015, 11:06 AM


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They are asking if the post-marketing obligations that Clinuvel has with the EMA will be sufficient for the FDA. If accepted, that would essentially mean no post-approval studies in addition to what they are already going to be beginning for the EMA.
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Justinian
Posted on: Aug 24 2015, 09:43 AM


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Clinuvel needs to prove that Scenesse prevents skin cancer, or at least doesn't promote it, through clinical trials. Saying it causes changes in nevi (moles) is what a lot of dermatologists say in the scaremongering articles which give Melanotan a bad name. This type of stuff probably factors into regulators decisions for other indications such as Vitiligo. And actually from everything I've read/researched, it just darkens existing nevi which could be a good thing in terms of detection since the moles were barely visible before.

What they need to do is release the results of the actinic keratosis trial. The problem is that to prove that it prevents skin cancer (by reaching statistical significance), you probably need a decent sized trial over an extended amount of time. Hopefully that actinic keratosis trial is large enough to do that. At the very least, hopefully that trial can show it doesn't promote skin cancer. Then again, this is actinic keratosis so the results don't necessarily carry over to melanoma, which is what people are worried about the most.
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Justinian
Posted on: Aug 23 2015, 06:50 AM


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"People with Psoriasis at twice the risk of depression."

http://www.medicalnewstoday.com/articles/298416.php

I've been one to say that Vitiligo is a cosmetic disease also, but it can definitely affect people psychologically. Mental health is slowly becoming more accepted as a legitimate issue with patients. I wonder if these types of studies are taken into considering when considering the risk/reward ratios for drug approval?

I wonder how much publicity Scenesse would get as Vitiligo treatment if Michael Jackson were still alive and struggling with Vitiligo?
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Justinian
Posted on: Aug 23 2015, 06:46 AM


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I'd prefer to not have Scenesse grouped with a drug that has a questionable safety and effectivity profile.
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Justinian
Posted on: Aug 18 2015, 11:51 AM


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Correct me if I'm wrong, but PW has been CEO less than 10 years right? And we're talking about 20 years of development here.

While PW is to blame for some minor (in the long run) delays here and there, in my opinion he is not responsible for a lot of the remaining 10 years even. After Epitan, it was basically like starting over. It's not his fault the regulators are so hung up on cosmetic off label use, while seemingly ignoring the fact that a tan also helps prevent the most common form of cancer in the world. If off-label use was not a concern to regulators, Scenesse would have been distributed in Europe for all of 2015 and the application for FDA approval would have been submitted by now. I would like to hear arguments if anyone thinks that would not be the case.
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Justinian
Posted on: Aug 15 2015, 04:23 AM


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How much UV exposure did you get during that time?

Thanks for the info.
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Justinian
Posted on: Aug 9 2015, 08:04 AM


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As a novice/young investor, my question to the more experienced investors is what is keeping the stock price down then? I see other biotech companies with more risk (no approved drugs) and not much better or worse upside (total potential value for all drugs being approved) that have a larger market cap.

My best guess (apart from not much recognition in the western world/not being listed on major stock exchanges) is the long term value. You said that this stock is basically guaranteed to provide value in the medium term with Europe EPP alone. But what value does this stock provide 10+ years down the line? The topical formulations patents expire around the same time as Scenesse, in the mid 2020's. This company only has those two drugs. Will they expand their pipeline by purchasing new intellectual property? If they do that, would you be confident that the current management can deliver on those? Will they somehow extend the patent life with new applications, or will they settle on just making a little money of of generics? Will they be bought out by a larger company at some point? Will they start paying dividends eventually to provide value to stockholders without having to sell the stock?

I'm just thinking that I could buy now and if I wanted to sell in 5 years, why would somebody in 5 years want to buy?

Sorry for a bunch of rambling questions.
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Justinian
Posted on: Aug 6 2015, 08:57 AM


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Posts: 229

On a more serious note, let me first say that this report is about Melanotan 2. Melanotan 2 is not the same chemical as Scenesse and affects more receptors that Melanotan 1/Scenesse is not believed to have an effect on and is much more potent. Only Melanotan 2 is known for the appetite supression and erections.

"Dr Mar said the drug had been linked to a range of significant problems for people. In one case, a 39-year-old man's muscles started breaking down with kidney dysfunction after a single dose."

This was from this guy http://www.ncbi.nlm.nih.gov/pubmed/23121206. He injected 6mg of Melanotan 2 at once. The recommended injection people go by is 1mg max, and people usually build up to that. People usually max out at 0.5mg now. This is the equivalent of taking 20 shots of vodka in a row and end up in the hospital. You would probably have to have like 10 Scenesse implants at once to even come close to this effect (which may not even happen since this guy used Melanotan 2).

""The drug will also discolour existing freckles and moles. There have also been reports of dysplastic changes arising in pre-existing moles and even melanoma developing in patients."

I've read a few case studies of this and the people who got these changes were very fair skinned and had a long history of tanning bed use. That could very well be the cause of the dyplastic moles. These people were already very high risk for melanoma.

This type of scaremongering has got to be annoying for Clinuvel to deal with.
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Justinian
Posted on: Aug 6 2015, 08:50 AM


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Posts: 229

Beware of Dihydogen Monoxide (DHMO)!

Dihydrogen monoxide is colorless, odorless, tasteless, and kills uncounted thousands of people every year.
What are the dangers of Dihydrogen Monoxide?
Most of these deaths are caused by accidental inhalation of DHMO, but the dangers of dihydrogen monoxide do not end there. Prolonged exposure to its solid form causes severe tissue damage. Symptoms of DHMO ingestion can include excessive sweating and urination, and possibly a bloated feeling, nausea, vomiting and body electrolyte imbalance. For those who have become dependent, DHMO withdrawal means certain death.

http://www.dhmo.org/truth/
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Justinian
Posted on: Jul 22 2015, 11:55 AM


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Posts: 229

You can't lose something you've never had. Clinuvel has been fighting an uphill battle because of the Epitan days (which I think is dumb, but that is besides the point).
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Justinian
Posted on: Jul 17 2015, 12:31 AM


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Posts: 229

My best guess (and maybe just wishful thinking) is that it means that off label use will be monitored less strictly in the USA than in Europe right now, and so the FDA will consider more than just EPP when approving the drug. If that's the case, then I can understand the FDA wanting some additional safety data.
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Justinian
Posted on: Jul 16 2015, 01:37 PM


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Posts: 229

It's hard to blame Clinuvel when they've had to run so many costly trials just to get to this point. It costs them tens of millions of dollars total to run these trials, and these are smaller than normal trials because it's an orphan drug. Phase 3 trials average a cost of over $25,000 per patient http://www.prnewswire.com/news-releases/ph...t-56447427.html
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Justinian
Posted on: Jul 16 2015, 01:33 PM


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Posts: 229

It is painfully obvious that they are making it much harder for Clinuvel because of worry about a tanning drug and/or lobbying. I follow some other cosmetic drugs and none that I know of have a a 5 year safety data for 100+ patients pre-approval, yet the FDA wants more safety data when according to the studies there have been no serious adverse affects reported. And recently many experts have come out in support of the safety/efficacy of the drug.

Clinuvel isn't free from blame though, they certainly didn't help themselves by mishandling trial data. And I think they skipped out on a few pre-clinical studies.
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Justinian
Posted on: Jul 10 2015, 03:22 AM


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Posts: 229

Could it be possible to submit the FDA application and then later submit the additional EU data? The FDA could review the trial data and other information first and then consider the additional data before they come to a decision. If clinuvel waits for 6 month of safety data first to submit the FDA application then I don't see how USA patients would have access by next summer.
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Justinian
Posted on: Jul 5 2015, 03:05 AM


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Posts: 229

"Investors would obviously prefer to see positive revenue numbers over mindless platitudes from doctors."

This isn't so obvious. A little bit back somebody on here posted a list of biomed stocks that have a market cap greater than Clinuvel's, with NO drugs past the Phase 2 stage. Phase 2 still has a very high failure rate. It isn't until Phase 3 that drugs have an about 50/50 chance I believe. It seems that, for whatever reason, investors aren't valuing the future potential of Clinuvel's drugs but they are for other biomed companies. All I can think of is that it is because it is not well known in the USA (no NASDAQ listing, no FDA approval yet), or that the length of patent protection is worrisome for these other indications.
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Justinian
Posted on: Jul 5 2015, 03:02 AM


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Posts: 229

Good points, but a lot of it is irrelevant with the 21st Century Cures Act. A huge part of it is listening to the "patient voice" which for Clinuvel strongly supports the drug. Clinuvel could have been silent because they wanted to wait and see how this act plays out, which is basically about to be approved.
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Justinian
Posted on: Jul 2 2015, 01:28 PM


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Posts: 229

"It is agreed that the strength of evidence of efficacy from the single pivotal trial is not strong enough to grant a Marketing Authorisation not subject to Specific Obligations."

Do you have a source for this? One part of the patient registry we know for a fact is to monitor off-label use. The other part could easily be for safety since the trials weren't as large as they would be for a drug with a larger patient base. Clinuvel also didn't perform any drug interaction studies if I remember one of the approval reports correctly. It's definitely been referred to as safety data when they said they plan to supplement the FDA submission with 6 month of safety data from this registry.
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