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Justinian
Posted on: Jun 23 2020, 01:12 PM


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$100+ here we come?
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Justinian
Posted on: Jun 9 2020, 11:01 AM


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Thats a good point. New York especially.
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Justinian
Posted on: Jun 9 2020, 10:46 AM


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I agree with your point, but technically Detroit is closer to the Northeast. Lots of flights from the northeast go through Detroit too.
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Justinian
Posted on: Jun 2 2020, 02:26 PM


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Get a center in the northeast and Texas and most of the country can easily make a day trip to get treatment. Glad to see new centers popping up either way.
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Justinian
Posted on: May 27 2020, 08:13 AM


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Can someone explain to me how they are testing XLP and EPP at the same time? Isnt that like comparing apples to oranges? Or can they analyze the data separately or something.
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Justinian
Posted on: May 27 2020, 08:11 AM


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I wonder if there are drug interactions with it too
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Justinian
Posted on: May 6 2020, 11:34 PM


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6 hours per week let’s you live a normal life. Here in the USA in any urban or suburban areas I bet the majority of people don’t spend 6 hours outside total in a given week. More rural areas it’s different.
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Justinian
Posted on: May 1 2020, 05:23 AM


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Oral is not practical unless Clinuvel works some magic somehow. People tried it with Melanotan with poor results. https://www.ncbi.nlm.nih.gov/pmc/articles/P...31/#sec1-2title

Transdermal patch may be the ideal way in the future, and lots of companies are working on that technology for various uses. Until then like you said an implant has benefits until the other benefits of Scenesse are proven in long term studies and more safety data is gathered. Safety so far may be a big advantage for Scenesse.

Here is a more recent article: https://www.sciencedirect.com/science/artic...319016414000590
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Justinian
Posted on: Apr 28 2020, 08:23 AM


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From what I read I couldn’t figure out if the next phase of centers opens all at once or as soon as one is ready. I hope they get a Texas and Northeast one open as soon as possible because of how many people that would serve.
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Justinian
Posted on: Apr 22 2020, 03:34 AM


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Also lots of the suppliers for this are from China. It would have been very easy for the government to seize large batches of it to try on patients.
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Justinian
Posted on: Apr 22 2020, 03:27 AM


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Specifically that’s Melanotan 2 which is more potent, and also increases libido and suppresses appetite. Its a smaller molecule which binds longer and to more receptors. Afamelanotide/Scenesse is referred to as Melanotan 1. People would have to dose in the range of 10-20x more of Melanotan 1 to get the same effects as Melanotan 2. These reasons are part of why the slow release implant is really helpful.
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Justinian
Posted on: Apr 17 2020, 07:25 AM


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I was curious so I looked up the list of locations where the MT-7117 Phase 2 Trial took place from ClinicalTrials.gov:
Los Angeles, California, United States, 90036
San Francisco, California, United States, 94143
Miami, Florida, United States, 33136
Brighton, Massachusetts, United States, 02135
New York, New York, United States, 10029Winston-Salem, North Carolina, United States, 27157
Columbus, Ohio, United States, 43215 Galveston, Texas, United States, 77555
Salt Lake City, Utah, United States, 84108


As we know, Clinuvel is already distributing in Miami, LA, and Detroit. So that directly overlaps with two places. Judging by the image in the recent release (which we all know hasn't been known to be the most precise), the next phase of the rollout includes the following locations:San Francisco, Seattle, Utah, Colorado, the Montana area, Houston, St Louis, Chicago, the North Carolina area, and it looks like either DC or Philly.
If they happen to keep most of the same locations for their Phase 2 trial, after phase 2 of the rollout I think it's going to be very difficult to get patients to commit to a clinical trial. 6 of the 9 areas looks like direct overlap, with the rest not far from a Scenesse location.

EDIT: This formatting is terrible and it changes when I hit submit.
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Justinian
Posted on: Apr 15 2020, 01:43 AM


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Would the take off have been as a result of release of the release of a financial report?
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Justinian
Posted on: Apr 14 2020, 07:07 AM


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Clinical trials are expensive. Tens of thousands cost per patient enrolled. It’s a lot of money to test if governments aren’t backing you.
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Justinian
Posted on: Apr 11 2020, 03:57 AM


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Interesting.

This is the article I was referring to that was posted here a while ago: https://www.dtnext.in/News/TamilNadu/2020/0...D19-impact-.vpf
“ The 13-page document ends with stating that existing drugs, including Daptomycin, Afamelanotide, Tetracosactide, Lanreotide, Ceruletide and Pasireotide “could control or reduce infection, including respiratory symptoms, fever, cough, shortness of breath, breathing difficulties, pneumonia, ARS (Acute Respiratory Syndrome) kidney failure and even death” as had been reportedly proved by computational studies.”

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Justinian
Posted on: Apr 10 2020, 07:32 AM


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We don’t have enough information to say either way. This company had public help to run the trial. These trials are way to expensive to run if there isn’t government buy in for some sort of accelerated approval. We don’t know if Clinuvel made a call or not. We also don’t know how well the science actually backs up Scenesse for this other than that one study (correct me if I’m wrong). Clinuvel scientists would surely know more.
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Justinian
Posted on: Apr 10 2020, 04:18 AM


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Shorts are at an all time high (I think) of 9.59% as of April 3rd. So that doesn’t explain the recent rebound.

What’s everyone’s predictions on when the SP will jump? April 15th? A few weeks after if announcements are made of first patient treated? Financials next quarter? Further away financials due to Coronavirus and/or ramp up of patients? None of the above?

I think it will jump a bit after the first patient is treated but only if the media picks up on it a lot. Otherwise I think we’re waiting until financial statements show a big increase which I’m not sure when that will be due to ordering timelines.
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Justinian
Posted on: Mar 31 2020, 06:48 AM


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I wonder if they have different purposes or are just three different tries at getting a working topical.
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Justinian
Posted on: Mar 23 2020, 02:36 PM


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My guess is that it’s just semantics. Everything could likely be good to go on that date but they don’t know if individual patients will travel and/or receive an implant on that exact day.
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Justinian
Posted on: Mar 23 2020, 12:23 PM


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Very good news. April was better than even my most optimistic prediction. This will hopefully give as much a bump to the price as possible once sales actually happen. I could see the drug/company getting a lot more publicity once it is actually in use and not just approved.

It's unfortunate that basically a once in a 100 years event will cause limited travel, but hopefully the three centers work out until the rest of the insurance stuff gets taken care of. It has decent coverage but without a Texas or New England site there will be a large amount of people unable to travel for the near future. No way they could have predicted that, though.
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Justinian
Posted on: Mar 19 2020, 12:48 PM


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Double post
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Justinian
Posted on: Mar 19 2020, 12:48 PM


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Also, very important: “ Needless to state that we are all counting down the clock to see the first US patient treated with SCENESSE®, while the FDA is reviewing the post-authorisation protocol for medical data entry in the Global EPP Disease Registry (GEDR).“
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Justinian
Posted on: Mar 18 2020, 01:35 PM


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Yeah definitely not right now. But maybe when preliminary phase 3 results are in or something like that.
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Justinian
Posted on: Mar 18 2020, 01:16 PM


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I definitely don't think it's likely, but thought it an interesting idea. Why do you say zero chance?
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Justinian
Posted on: Mar 18 2020, 11:10 AM


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One thing I've been thinking about is if Clinuvel would try to acquire the rights to MT-7117, if indeed it appears to be effective/safe and would take some of the market share.

Mitsubish Pharma has several drugs that it licensed out to other companies, along with several that it acquired from other companies, the list is below. So they seem to be open to the idea. In the past Clinuvel has talked about eyeing acquisitions.

https://www.mt-pharma.co.jp/e/develop/pipel...ipeline1912.pdf

Seven drugs are licensed from other companies. 4 are licensed to other companies. There seems to be a focus on them keeping rights in some Asian countries.

Perhaps some deal could be worked out where Clinuvel acquires the rights? It seems like it could make sense for both companies. From the perspective of Mitsubishi, Clinuvel already has an established presence in the market and with regulators, and already has a tracking database for post approval. Mitsubishi will have difficulty to recruit for a phase 3 EPP trial, Scenesse is extremely safe (MT-7117 is likely at best as safe as Scenesse in terms of side effects) and can be monitored much more easily by worried regulators, and is a one time application every 2 months as opposed to daily or multiple times a day. Eventually, Clinuvel may have the holy grail treatment of a topical product too. So how much money can MT-7117 really make here?

Some combination of up a lump sum payment for rights, Mitsubishi getting a percentage of revenue, and/or Mitsubishi retaining rights in some Asian countries could make sense.
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Justinian
Posted on: Mar 15 2020, 11:44 AM


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Other people had indeed said it. It still makes no sense. Whatever you’re measuring against would be skewed if there’s different diseases involved.
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Justinian
Posted on: Mar 15 2020, 09:16 AM


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That makes no sense. If it’s not just EPP then all statistical measures are meaningless.
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Justinian
Posted on: Mar 12 2020, 01:02 PM


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Could also be manufacturing/distribution holding things up too? That was what caused the FDA approval delay.
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Justinian
Posted on: Mar 12 2020, 11:56 AM


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Oh you’re probably right. I guess that could mean what I was referring to, but it could also mean other things.
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Justinian
Posted on: Mar 12 2020, 11:43 AM


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Double post
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Justinian
Posted on: Mar 12 2020, 11:43 AM


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“I will speak to you in a few months unless the news asks me to write earlier”

Is it just me or does this statement basically mean that? Why else would the news want to speak to him. News means media I assume?
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Justinian
Posted on: Mar 10 2020, 07:26 AM


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Source?
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Justinian
Posted on: Mar 5 2020, 07:21 AM


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My dream is that Clinuvel is going to do something like that and the shorters all get demolished after that and an earnings report that includes US sales.

The language they used was “by the end of 2020” not “at the end of 2020”. So technically it could be any time now. But realistically we are several months away still.
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Justinian
Posted on: Mar 5 2020, 12:57 AM


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Interesting read about peptides (Scenesse) vs small molecules (MT-7117).

https://www.biostock.se/en/the-rise-of-ther...-the-forefront/

“Biologics (large molecules), unlike small molecules, often share similarities with the body’s own molecules and bind their target(s) in the body quite specifically, making them very effective against serious conditions and giving rise to fewer side effects.”

“Despite the size difference, peptides and biologics (large molecules) share the fact that they are highly specific to their target and can produce a long-lasting effect.”

“Overall, therapeutic peptide development is considered highly attractive by pharma companies because of their high likelihood of approval (LoA) or probability of success (POS) in clinical trials compared to small molecules.”

I would still like to see more data about MT-7117’s “acceptable” safety profile.
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Justinian
Posted on: Mar 5 2020, 12:43 AM


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If all info is correct, the extra 26 weeks without placebo would be to keep patients on MT-7117 instead of Scenesse I imagine. Or maybe for more safety data too.
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Justinian
Posted on: Mar 4 2020, 08:37 AM


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The last roadblock has to either be that or the distribution and manufacturing stuff with the contractor (I think).
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Justinian
Posted on: Mar 4 2020, 03:58 AM


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Nice find. Website looks pretty nice IMO.

Would there be a reason to have the website up way earlier than Scenesse would be available to patients? It even says ask your healthcare provider if it’s right for you.
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Justinian
Posted on: Mar 3 2020, 11:41 AM


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Unless there is some change to the dosing and/or protocol, why would another phase 2 be needed? Also if they ran concurrently it seems the additional phase 2 would be unnecessary. What could it add over a larger phase 3 trial?
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Justinian
Posted on: Mar 3 2020, 08:05 AM


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It’s probably both
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Justinian
Posted on: Mar 2 2020, 02:27 PM


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CUV is definitely impacted. Scenesse is not.
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Justinian
Posted on: Feb 29 2020, 01:20 AM


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US markets are still going down. If this holds, can we assume the ASX and CUV will drop again Monday then?
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Justinian
Posted on: Feb 28 2020, 06:26 AM


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For them no required post approval tracking plan, and no training doctors/hospitals though.
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Justinian
Posted on: Feb 28 2020, 06:19 AM


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I think the EMA stuff is why Clinuvel went silent on their planned cosmetic/OTC product release.

I wouldn’t be surprised about take over interest. It’s one of the few rational things that would explain part of the shorting. But if management wants to go that route, why even mention acquiring other entities at all? I think it could be that they are just taking the long route and don’t care at all about the short term share price. They don’t want to waste effort (for better or worse) with marketing and updating shareholders.
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Justinian
Posted on: Feb 28 2020, 02:17 AM


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The exact wording is “by end 2020”. I’m hoping it’s earlier too. It stinks for the patients. The good news for us is that USA should be able to have 6 implants a year and there will be need for it all year around to some extent.
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Justinian
Posted on: Feb 27 2020, 09:40 AM


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If the starting date for the share price for the performance rights is flexible, that means that the CEO is basically incentivized for a lower share price in the short term which is very weird. I can't seem to find the link to the details of the performance rights plan announcement but I'm too lazy to look too in depth. I'm not too worried about the share price in the long term but in the short term it is rather frustrating.
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Justinian
Posted on: Feb 27 2020, 04:16 AM


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R&D won’t factor into negotiations. But I think the price is fine I’d rather they focus on expanding to 6 implants a year when needed. A higher price makes negotiations harder and there is already pushback from some European countries there. And once more indications are approved the price is going to drop anyway so this would just be a short term fix.
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Justinian
Posted on: Feb 26 2020, 03:29 AM


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What were these performance rights awarded for in the first place? The most recent announcement says it’s as described in the 2014 plan but I’m too lazy to look it up on my phone.
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Justinian
Posted on: Feb 12 2020, 02:16 AM


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Clinuvel has quite a few patents (who knows how useful they will be here) and also the implant will make it more difficult for generics to enter the market.
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Justinian
Posted on: Feb 6 2020, 11:35 PM


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It still doesn’t make entire sense to me. If this is explaining everything then the shorts should have decreased in October but only did so in momentary spikes that doesn’t account for the rise in SP that remained post approval after the initial sell off. It instead leveled off. But either way your statements don’t contradict my original point that shorting is explained mostly by events that occurred before November.
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Justinian
Posted on: Feb 6 2020, 11:59 AM


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I haven't looked at actual short numbers so I decided to look into it a little bit. Any input on this analysis would be appreciated.

ASX200 Inclusion Announced: June 14
https://www.clinuvel.com/wp-content/uploads...X-200-INDEX.pdf
MT-7117 Study Results Announced: Nov 11
https://www.mt-pharma.co.jp/e/release/nr/20..._MTPC191111.pdf


Shorting took off around the time of the ASX200 inclusion and rose steadily until about 5.89 percent until leveling off for a bit at the end of August (see below). It then picks up again in November around the time of the MT-7117 study announcement although it technically started going up a little bit around mid October a week or two after FDA approval. Shares shorted are currently 8.76%. So about the majority of the shorting occurred before the MT-7117 announcement and appears more related to ASX200 inclusion, unless there was inside knowledge.
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Justinian
Posted on: Feb 6 2020, 10:12 AM


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I was just responding to earlier comments where one pill a day is the “worst case” scenario from Clinuvels perspective. I have no idea what the dosage actually is.
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Justinian
Posted on: Feb 6 2020, 08:30 AM


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Also variable absorption in the stomach.

If it’s one pill a day vs implant every 2 months I’d definitely prefer the implant. For vitiligo who may need a more frequent dosage I’m not as sure, but if clinuvel figures out maintenance treatments or locally active treatments applied topically then that’s far superior to either option.
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Justinian
Posted on: Feb 5 2020, 12:24 PM


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There's only so much the PR department can do without actual news to talk about. FDA rollout is waiting on the post-approval tracking stuff, manufacturing, and insurance. There's probably some stuff that could be talked about here but it's probably pretty mundane. We know Australia and France stuff has been submitted, and the ball is in NICE's court in England. Vitiligo is waiting on a meeting with the FDA I believe for approval for the next trial. OTC products are a mystery but I'm guessing the last newsletter about how regulators are telling Clinuvel to tone it down on the website has something to do with it. I'm pretty sure that all along these were supposed to be released after Scenesse is rolled out anyways. With topicals nobody should really be expecting much and anything there would be a huge bonus, unless the topical is simply Scenesse being absorbed systemically. Researchers have been testing similar molecules applied topically for decades with little success. Getting it into the skin correctly is very tricky.

Let's just hope Scenesse can be rolled out in the next few months in the USA during the summer months.
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Justinian
Posted on: Feb 5 2020, 10:45 AM


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We’re now at levels slightly below pre-ASX inclusion which makes no sense.
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Justinian
Posted on: Jan 23 2020, 10:50 AM


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It should be an interesting balance sheet for sure. Increase in expenses will mean stuff is going on in the background which is also good.
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Justinian
Posted on: Jan 20 2020, 01:39 PM


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I would think a lot of the US would need treatment some of the winter. The latitude in Florida lines up with North Africa. Most northern states line up with with south Europe.
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Justinian
Posted on: Jan 16 2020, 02:29 PM


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Delete
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Justinian
Posted on: Jan 15 2020, 12:42 AM


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Several trials were held in the US right? Those doctors may be certified or just need the paperwork to be certified basically.
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Justinian
Posted on: Jan 14 2020, 10:48 AM


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This forum needs an announcement more than the stock price.
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Justinian
Posted on: Dec 12 2019, 06:12 AM


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I recall average volume hovering around 30k a day the last few years. Maybe it’s been more the last 6-12 months since FDA submission but I don’t think it was more than 100k on average. Now it’s 325k according to the iPhone stock app. A while ago if we saw that much volume it would be on big news. It just doesn’t seem like CUV has that amount of retail traders trading constantly to lead to large volumes.
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Justinian
Posted on: Dec 11 2019, 01:32 PM


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Average volume since approval has been really high. I believe there was only one notice of a large holder/fund dropping in holdings. Where is all this volume coming from? Is it just retail investors?
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Justinian
Posted on: Dec 6 2019, 02:01 AM


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Which thing are you “reading into”? I glanced at the announcements and did I miss something?

Edit - never mind I get it now.
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Justinian
Posted on: Dec 4 2019, 12:45 PM


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That makes sense. The implant really does seem to be effective and the fact that it's only active for 10-14 days is huge in terms of long term safety. I recall the regulators or Clinuvel stating that constant long term dosing was a concern in one of the reports a few years ago.

I may have missed it, but what makes you think that MT-7117 isn't that effective for photo-protection?
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Justinian
Posted on: Dec 4 2019, 11:55 AM


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Can you elaborate on what you mean by partial agonist?

From my understanding, light skin types have partial or total loss of MC1R function when natural Alpha-MSH binds to it. Afamelanotide binds to MC1R completely regardless of the loss of function to natural Alpha-MSH. Are you saying that MT-7117 may give an effect similar to this partial re-gain of function? I'm not really familiar with the "agonist" part of receptors. Can different molecules bind in more/less "strength"?
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Justinian
Posted on: Dec 3 2019, 10:58 AM


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I agree too. It would help with US rollout and maybe with some of the European countries too.

In response to some other posts I saw here:

-With MT-7117, it’s not an all or nothing thing. Best case Is MT-7117 gets rejected or development stopped, worst case is MT-7117 steals a significant market share but not all. There will be a need for both kinds of formulations.

-With Clinuvels end game and DNA repair, Clinuvel had mentioned acquisitions earlier. If Clinuvel doesn’t get acquired, there are other derm products and also other melanocortin products Clinuvel could buy the rights to such as Rhythm pharmaceuticals. That’s in addition OTC products to expand the product line.
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Justinian
Posted on: Nov 30 2019, 04:33 AM


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The fact that 90% of approved drugs don't have any more benefit than existing drugs stat has a lot of intricacies. For every one drug approved that doesn't show increased efficacy versus approved drugs, there could be 5 that were stopped during development or denied by the FDA. A lot of the ones approved are likely completely different mechanisms of action than the existing drugs. This is not the case for MT-7117 since both use MC1R activation. If the drug is a different mechanism of action it could mean the effects of the drug are additive when used together with others, which could be very useful for things like cholesterol and blood pressure drugs. This could mean that certain patient subgroups that didn't respond to approved treatments now have an effective option. It could mean ones that had side effects from approved treatments don't get any with the new one. It could mean the new drug is the same efficacy as existing drugs but is safer.

Basically none of these is the case for MT-7117 with what we know currently.
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Justinian
Posted on: Nov 30 2019, 02:39 AM


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It got fast track before Scenesse was approved though. Fast track is specifically for an "unmet clinical need" which was true before but not now.

Yes there is no hard requirement, but that unknown with how the FDA will treat it is still huge for MT-7117 especially if there are ANY safety issues with it.

I'm curious how in a previous post you state the bioavailability trial is a huge success when the results haven't been released from what I can tell? It's not posted on the clinical trials website and I couldn't find any news release about it. The fact that a hepatic function trial is needed is a pretty big red flag in my opinion. Also this trial excludes ALL medications unless approved by the trial investigator. This includes OTC meds even except for Tylenol. This may just be semantics, but by itself this doesn't tell us that the previous trial meant everything was a success. The bioavailability trial also doesn't appear to test drug interactions even though the title implies that it does.
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Justinian
Posted on: Nov 30 2019, 01:31 AM


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Good questions, I have no idea.
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Justinian
Posted on: Nov 30 2019, 01:06 AM


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The trial I listed hasn’t even started recruited yet. Are you saying the website was made prior to the previous trial you mentioned so it’s outdated?
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Justinian
Posted on: Nov 30 2019, 01:02 AM


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I follow the hair loss industry, and all phase 3 studies are compared to minoxidil or finasteride, the two existing treatments.

Some so this on phase 2 also. There have been a lot of drugs that show comparable or slight improvement over existing drugs but the companies stop developing them because there isn’t enough of a difference.
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Justinian
Posted on: Nov 29 2019, 11:42 AM


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In regards to MT-7117, here are a few other things which come into play:

FDA Approval requires showing benefit/risk over existing therapies. If the drug has even moderate side effects I don't see it getting approved given that Scenesse has minimal side effects.

"FDA reviewers analyze the condition or illness for which the drug is intended and evaluate the current treatment landscape, which provide the context for weighing the drug’s risks and benefits. For example, a drug intended to treat patients with a life-threatening disease for which no other therapy exists may be considered to have benefits that outweigh the risks even if those risks would be considered unacceptable for a condition that is not life threatening."
https://www.fda.gov/drugs/development-approval-process-drugs

From what I can gather for the upcoming trial there are much more strict exclusion criteria compared to Clinuvel's trial. At least some of these appear to be due to the endpoints being used that measure inflammation and "PGx pharmacogenetics", but not all of them. For example, "Presence of clinically significant acute or chronic renal disease", "Chronic treatment with centrally acting analgesic agents including but not limited to opioids and opioid derivatives within 4 weeks before Randomization (Visit 2).", "Drugs known to be predominantly metabolized by CYP3A4. (e.g., aprepitant, cyclosporine, pimozide, quinidine, and tacrolimus), for which elevated plasma concentrations are associated with significant medical events.", "Drugs known to increase the gastric pH (e.g., omeprazole, lansoprazole, sodium hydrogen carbonate, aluminum hydroxide)".
https://healthcare.utah.edu/clinicaltrials/...p?id=FP00012322

Someone mentioned that oral route of administration is without a doubt the preferred method of administration, but that is not always the case. In the above exclusion criteria include medications that affect the gastric pH. Can foods affect the medicine absorption? The above study has the exclusion criteria "Drugs known to be predominantly metabolized by CYP3A4. (e.g., aprepitant, cyclosporine, pimozide, quinidine, and tacrolimus), for which elevated plasma concentrations are associated with significant medical events." Grapefruit juice, for example, has been known to cause problems with a bunch of medications involved with CYP3A4 leading to over-absorption of medications while leading to under-absorption in others. This is just one food. Can EPP patients really risk that?
https://www.fda.gov/consumers/consumer-upda...-drugs-dont-mix
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Justinian
Posted on: Nov 28 2019, 01:46 AM


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Do they not have a placebo in their trial?
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Justinian
Posted on: Nov 28 2019, 01:01 AM


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How do you know trials will slow down rollout? Wouldn’t it be preferable to use an approved drug instead of risking it in a trial? This all assumes Clinuvel is distributing by next spring.
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Justinian
Posted on: Nov 27 2019, 10:13 AM


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No but I recall them saying the distribution/post approval study of Scenesse will be reported to this department https://www.fda.gov/about-fda/center-drug-e...y-ose-divisions
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Justinian
Posted on: Nov 27 2019, 09:44 AM


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Here are some concerns with MT-7117.

The wording in the news release could be just standard neutral business reporting lingo but it makes it sound like there are at least moderate side effects: "MT-7117 was generally well tolerated with an acceptable safety profile." https://www.mt-pharma.co.jp/e/release/nr/20..._MTPC191111.pdf

I don't know the exact mechanism of action but there may be a risk of MT-7117 affecting other melanocortin receptors which could cause many side effects. It has a much smaller molecular size than Scenesse.

Finally, this is also just speculation on my part, but this drug may need to be taken every day unless they have a dosing strategy in place to facilitate breaks. I don't know if the FDA would like every day dosage without breaks. There is worry about receptor de-sensitization and/or up-regulation due to prolonged dosage. Scenesse by default with an implant every 2 months has a break built in.


And another issue is the FDA may prefer Clinuvel with the implant which can have off-label use controlled much easier. For all we know, the FDA may have directed the post-authorization studies Clinuvel is using and won't want any off label use until DNA repair is proven.
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Justinian
Posted on: Nov 26 2019, 10:25 AM


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At this point I’m skeptical even positive trial results will stop the shorters much. It will only change on increasing profits in financial reports and/or a NASDAQ listing to increase liquidity.
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Justinian
Posted on: Nov 26 2019, 09:41 AM


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The letter also says he held “research executive roles” which would be pretty key for the pipeline products.
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Justinian
Posted on: Nov 26 2019, 09:37 AM


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Just to put on a tinfoil hat...

If that one theory someone posted about shorting and takeover price is true, then this line of thinking is exactly what the shorters are trying to create.
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Justinian
Posted on: Nov 25 2019, 09:46 AM


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I don't know the specifics but small molecular size is the main reason (I think) that Melanotan II has so many more side effects than Melanotan I / Scenesse.
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Justinian
Posted on: Nov 22 2019, 10:26 AM


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If that happens, which I think is pretty unlikely, we can hope Clinuvel has their patents done right. It’s extremely unlikely somebody sweeps the market any time soon, it would be more likely they take some market share for certain diseases.
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Justinian
Posted on: Nov 20 2019, 11:38 AM


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This could be huge. I wasn't expecting to prove this through trials for a long time even though it's pretty straightforward that Scenesse will be very good at preventing skin cancer. I was expecting this to require a huge study with thousands of people over a long period of time in order to get enough skin cancer instances to reach statistical significance. But doing it this way could be much easier, as long as the FDA accepts this endpoint. Cancer is due to DNA damage and so proving less DNA damage you would think would be acceptable.
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Justinian
Posted on: Nov 20 2019, 11:32 AM


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It's already been proven in vitro pretty much.

"Melanin content and MC1R function independently affect UVR-induced DNA damage in cultured human melanocytes."
https://www.ncbi.nlm.nih.gov/pubmed/16827749

"MC1R: Front and Center in the Bright Side of Dark Eumelanin and DNA Repair"
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6163888/
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Justinian
Posted on: Nov 14 2019, 12:18 PM


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Out of curiosity what are the other barriers to rollout?
Also I was under the impression that medicaid negotiations could take a while, though, even if private insurers aren't a barrier.
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Justinian
Posted on: Nov 12 2019, 11:01 AM


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I was thinking about the letter from the "remuneration committee chair" and I was wondering what exactly a takeover offer would take to pass. I don't know exactly how it would work voting wise and I recall people saying a lot of retail holders would have to agree. It is just in the back of mind if the chairman knows something we don't and a decent takeover offer (say $50-60 AUD or something along those lines) could be in the works if people would rather just cash out now than settle for the company's extremely long term mode of operation. I know a lot of us would rather wait a few years to get a much larger reward (and disagree with things such as the performance rights recession clause), but perhaps not everyone feels that way.
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Justinian
Posted on: Oct 19 2019, 12:57 PM


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It really depends on what the endpoint is. For EPP, it was difficult to find any endpoint besides time spent in the sun. For XP, it doesn't have to be time spent outside. It could be how many instances of skin cancer are seen since a fairly significant amount of these are seen in people with XP. The participants wouldn't have to change any of their behaviors or deliberately expose themselves to UV. The placebo group and treatment group could both behave how they would without treatment so the placebo group isn't really any worse off than if they weren't in the trial. This won't work if people have alternative options that almost entirely prevent skin cancer though, since they would just exercise those and there wouldn't be room to see an improvement by using Scenesse. In that case deliberately exposing themselves to UV would be unethical.
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Justinian
Posted on: Oct 18 2019, 03:05 AM


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That seems like quite the market inefficiency if that’s common for biotechs? I’d imagine the risk of approval is way more than commercialization. Sure sales numbers can vary but it’s not an all or nothing thing like approval.
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Justinian
Posted on: Oct 16 2019, 02:26 AM


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I’m pretty sure you’re right. The new molecules for topicals could be OTC but would still have to go through the normal 3 phase trials. I highly doubt the OTC product being released soon induces melanogenesis, I bet it’s something else.
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Justinian
Posted on: Oct 14 2019, 06:30 AM


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I think you’re right on. The implant serves as an easy way to keep competitors away. To my knowledge the topical/OTC products will not have market exclusivity from patents for very long, so the longer competitors are kept from starting a product and if Clinuvel can be a “name brand” then it’s much better.
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Justinian
Posted on: Oct 14 2019, 02:57 AM


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That’s why I refuse to sell any now. Before approval the stock was this high and now there’s virtually 0 risk.
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Justinian
Posted on: Oct 12 2019, 06:28 AM


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I imagine a dual NASDAQ listing, like what Avita did, doesn’t require that much work? I assume it costs something but the ADR bank handles most of it?
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Justinian
Posted on: Oct 11 2019, 12:02 AM


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I looked it up and it grants an extra 2 years of market exclusivity for orphan indications though, which is a pretty big deal for some drugs. I wonder if management is hoping to avoid a systemic implant for children and use a topical, or if they just need to use a lower dose implant.
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Justinian
Posted on: Oct 10 2019, 11:23 AM


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Something else I missed was NASDAQ listing.
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Justinian
Posted on: Oct 10 2019, 10:47 AM


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There's no way I'm selling yet. Perhaps a little once CUV gets to 50. Although if I had as many shares as some people on here I definitely would have sold a little in the mid 40's just to enjoy life with. Nothing below that though because there is virtually no risk anymore and the stock was upper 30's a few months ago.

In the near future we have a lot to look forward to:
  • -US Rollout (as soon as manufacturing/insurance negotiations/doctor training is done since there can be implants every 2 months and southern US has strong UV index)
  • -EU expansion (NICE appeal, several new countries, more patients in existing countries, and more than 4 implants per year for existing patients)
  • -Pediatric version, with increased revenue and 2 year label extension in the USA once developed
  • -Australia/Japan approval
  • -OTC Product rollout
  • -Trial news for other indications
  • -New molecule trials (topical)
  • -Possible acquisition targets

Anything else I'm missing?
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Justinian
Posted on: Oct 10 2019, 08:53 AM


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This bit was in the FDA approval announcement by Clinuvel, though.
QUOTE
Post-approval the novel pharmaceutical therapy will be monitored by the Office of Surveillance and Epidemiology which is charged with the responsibility to oversee the safe use of SCENESSE® during commercial distribution. The FDA agreed with the intention to harmonize the US EPP Disease Registry with one established in Europe by CLINUVEL to monitor long-term use of SCENESSE®.

I think in Europe the doctors had to go through a training to offer the implant. I bet something similar is going to be required in the USA.
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Justinian
Posted on: Oct 10 2019, 08:48 AM


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Can you explain more about how Scenesse is still needed to stop Vitiligo progression if JAK inhibitors are used?
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Justinian
Posted on: Oct 9 2019, 04:33 AM


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I’m ok with the EMA having those rules in the past. They approved it early and the data was useful. NICE on the other hand...
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Justinian
Posted on: Oct 9 2019, 03:40 AM


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CLVLF up 20% right now
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Justinian
Posted on: Oct 9 2019, 02:25 AM


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You should do it.

Although close of business in the USA lines up pretty well with start of business in Australia, so it makes sense we’ll have to wait a few hours. Maybe we’ll get lucky though.

I’m still worried Clinuvel is going to have to prepare some letter for the FDA’s decision of approval... “but” something.
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Justinian
Posted on: Oct 8 2019, 04:51 AM


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Double post
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Justinian
Posted on: Oct 8 2019, 04:51 AM


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I try to put it in perspective by imagining how people with EPP feel right now, waiting to see if they can go outside without pain.

It helps some but I’ve still been very anxious the last few days.
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Justinian
Posted on: Oct 2 2019, 11:07 AM


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I’m gonna laugh when approval comes Friday anyway
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Justinian
Posted on: Oct 1 2019, 10:17 AM


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I was thinking something like that. Or possibly some new draconian post approval restriction where it’s approved but distribution gets delayed or something.
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Justinian
Posted on: Oct 1 2019, 08:54 AM


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I agree with you that that’s what should happen, but my gut is still telling me 75% chance approval, 24% chance delay of some sort, 1% chance rejection.
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Justinian
Posted on: Oct 1 2019, 02:09 AM


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That applies to CLVLF too right?
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Justinian
Posted on: Sep 30 2019, 07:36 AM


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If there is US approval and successful rollout, something to keep in mind too is that the dividends should be issued more often and/or increase by quite a bit. CUV is in a good financial position right now to pursue other indications at the same time.
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Justinian
Posted on: Sep 29 2019, 02:06 AM


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Probably hoping for an early approval which doesn’t seem to be happening now.
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Justinian
Posted on: Sep 27 2019, 10:19 AM


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I looked at FDA approvals for this year and the day of the week for the announcement seemed pretty spread out. Of course with CUV it will certainly be the last possible minute.
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Justinian
Posted on: Sep 26 2019, 09:06 AM


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It kind of made sense to me when the SP was really high a little bit ago. Now, not so much. The SP doesn’t have much lower to go because of Europe sales and all public data supports that going well. On the other hand, approval could lead to a large SP increase.

My biggest concern is just more delays, perhaps involving some sort of off label management even though that could be new territory.
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Justinian
Posted on: Sep 25 2019, 12:28 PM


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That would explain the correlation with NEA right?
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Justinian
Posted on: Sep 23 2019, 10:24 AM


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It appears the FDA has it’s own announcement for the approval on the Friday before. https://www.fda.gov/news-events/press-annou...enopausal-women
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Justinian
Posted on: Sep 21 2019, 01:20 AM


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I think the standard is to issue the response at COB, after markets close, the Friday before the date.
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Justinian
Posted on: Sep 20 2019, 11:29 AM


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Didn’t someone post a study a little bit ago about how Scenesse lowered protoporphyrin? I can’t find it through Google.
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Justinian
Posted on: Sep 19 2019, 04:39 AM


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Their response to that would probably be to suck it up and go live in a cave, they don’t need the medicine anyway.
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Justinian
Posted on: Sep 13 2019, 05:03 AM


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I’d prefer to not use the term Barbie drug. That was originally for Melanotan 2 which is different from Scenesse. In addition to skin tanning, that drug increases libido and decreases appetite, hence the nickname.
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Justinian
Posted on: Sep 12 2019, 02:06 AM


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This line of reasoning about dark moles is frustrating. Problem moles/nevi become darker even without afamelanotide. It makes sense the body would send more melanin to protect an area from further damage. It’s not actually a bad thing for them to be darker, it’s more protection. Light skin people with high risk of skin cancer tend to have light colored moles, whereas darker skin people with low risk of skin cancer tend to have darker moles. It makes sense if you are injecting melanocyte stimulating hormone that your phenotype becomes more like the latter.
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Justinian
Posted on: Sep 10 2019, 11:25 AM


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It's just back to the price the stock was at a week ago.
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Justinian
Posted on: Aug 29 2019, 12:03 PM


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6 extra hours a week is a lot, so that's good. In my opinion that's a pretty large impact on quality of life.

But on the other end of the spectrum there were no differences in number/duration of phototoxic reactions? I assume this is per hour in sunlight, not total? (since the patients were in the sun a lot more)
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Justinian
Posted on: Aug 29 2019, 11:19 AM


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I don't have a strong opinion either way, but just to play devil's advocate:

Management does have some leverage though. I'd imagine the alternative if they wanted to leave is a buyout by a larger company. The potential gain is much larger without the buyout.

They probably had a lot of unplanned work due to the FDA issues. And if they hired a lot of additional help the expenses would go way up.
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Justinian
Posted on: Aug 20 2019, 11:34 AM


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I feel like this is the first time the stock has gone up after a newsletter
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Justinian
Posted on: Aug 19 2019, 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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