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Johnny H
post Posted: Apr 28 2020, 10:55 AM
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In Reply To: KRD's post @ Apr 28 2020, 10:38 AM

Seeing as how Clinvuel is trying to take IR more seriously now, I'd love to see a press release about the outcome of the meeting. Nothing with commercial secrets, obviously.

Something alone the lines of "Clinuvel and FDA agree on primary endpoints to advance Scenesse for treatment of Vitiligo"

Meeting is in 2 days; they should have something ready to release on Thursday market open.

If Clinuvel requests and receives a Special Protocol Assessment from the FDA, they should announce it to the market immediately. SPAs are binding on the FDA, meaning they have to accept the results of the trial.

More about SPAs attached.
Attached File(s)
Attached File  Special_Protocol_Assessment_Guidance_for_Industry.pdf ( 181.98K ) Number of downloads: 98


"In today’s world some shareholders enjoy complaining to Board and management but then they do not sell their stock, they hold on and sometimes buy even more."

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post Posted: Apr 28 2020, 10:38 AM
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In Reply To: Johnny H's post @ Apr 28 2020, 09:22 AM

A growing company with $62M of cash in the bank and no debt. Certainly few if any other peers can make that claim. The most encouraging news was that the FDA meeting this week is apparently still taking place.

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post Posted: Apr 28 2020, 10:11 AM
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In Reply To: Clinhope's post @ Apr 28 2020, 09:08 AM

ICU patients in general have higher risk of thromboembolic events. Immobilization and hypoxia are huge, infection in general also a risk.
Afamelanotide would be used as a treatment in early stroke (reduce ischemic tissue (at risk-penumbra) to progress to infarcted (dead) tissue.

Incidence of thrombotic complications in critically ill ICU patients with COVID-19

COVID-19 may predispose to both venous and arterial thromboembolism due to excessive inflammation, hypoxia, immobilisation and diffuse intravascular coagulation. Reports on the incidence of thrombotic complications are however not available.


Finally, we propose that, rather than treating all patients with COVID-19 infections at the ICU with therapeutic anticoagulation, physicians should be vigilant for signs of thrombotic complications, and order appropriate diagnostic tests at a low threshold [5].

post Posted: Apr 28 2020, 09:36 AM
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In Reply To: PortugueseMan's post @ Apr 27 2020, 07:11 PM

Can someone explain the significance of this? Are we talking about a drug that would impact vascular health?

Johnny H
post Posted: Apr 28 2020, 09:22 AM
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Quarterly out.

$5.37 million cash receipts.
Cash on hand increased $4,894,000
Cash equivalents $62,329,000

For a company in the process of a massive expansion, this is a pleasant surprise.
Attached File(s)
Attached File  44h9fbybw6jbfs.pdf ( 336.27K ) Number of downloads: 141


"In today’s world some shareholders enjoy complaining to Board and management but then they do not sell their stock, they hold on and sometimes buy even more."

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post Posted: Apr 28 2020, 09:08 AM
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In Reply To: macgyver's post @ Apr 28 2020, 06:35 AM

If Covid actually is the causation of these stroke victims, and they were asymptomatic or mildly symptomatic then, i can see how a positive test for Covid could result in “prenumbra” being administered as you said for preventative reasons. Seeing as a vaccine is likely years away and even if one were developed the need to safely treat covid patients will be with us forever.

I don’t think PW has let this issue go unnoticed.

Member of the “ALL-IN” club 2018.

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post Posted: Apr 28 2020, 08:54 AM
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does anyone have some informations about the Type C Meeting tomorrow on 29.04.2020?
is this still valid date or is it delayed?
how will the meeting results comunicate? will the results move the SP or is this just a "too small" milestone?

post Posted: Apr 28 2020, 08:23 AM
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In Reply To: Frogster's post @ Apr 28 2020, 08:19 AM

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.

post Posted: Apr 28 2020, 08:19 AM
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Desiree Lyon on a public facebook group today:

"Re: SCENESSE We at APF spoke with a representative from Clinuvel today. They are working very hard to open more treatment centers. Also, they are helping individuals with insurance and assistance needs.

First , however, epp people need to register on to receive an ID number . Having the ID number is essential to receive treatment, assistance , insurance help, etc. Please secure your ID number today at! Call APF if you need us."

Dr Wolgen is a magician. His end game for Scenesse will impress, or even amaze. En route, along with glimmers of truth, there will be distractions, illusions, sleight of hand and misdirection. Enjoy the ride.

"Our ability to bring this drug to market does not hinge upon its efficacy, but only on our ability to keep deadlines" Philippe Wolgen CEO March 2006. Remember this when the Chair or CEO get aggressive in response to questions about their execution against deadlines.

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post Posted: Apr 28 2020, 06:35 AM
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In Reply To: Clinhope's post @ Apr 28 2020, 03:08 AM

I think Prenumbra will be preventative, like the future DNA repair drug will be preventative i.e preventing skin cancer from forming. However, if Prenumbra can be administered and effective immediately following a stroke that would be quite remarkable.


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