Clinuvel

Billy Boots

Well-known member
When I went into Epitan a couple of decades ago, I went in because of the tanning effect and supposed to stop Melanoma's......so explain to me what happened? Have I been dudded because I certainly feel so.
 

johnnytech

Moderator
Staff member
I can only hope that it will be achieved in the next 3 years
It will be 2 years, not 3 years. As much as we want the company to try and bring future fantasy into the stock now and raise the PE, we know they are on their own organic growth path.

Their timeline is AGM 2023. It's been defined and revealed as a major milestone for a long time now but we don't talk about that much.

I think it's more of a certainty that the stock will be 150 at least by November 2023 than any predictions in the next 12 months.
 

FarmaZutical

Well-known member
@johnnytech I believe I’ve mentioned it before, but the 7,5 bn marker confused me at first. Why not 8 or 7? Why the ,5? I think it’s because the goal is a buy out at a 100% premium which would put the price tag at $15 bn market cap. 2023 sounds fair to assume, but we should now well before if we are in a path to that or not. If the early XP trials are negative and if AIS doesn’t work out, I don’t see us reaching $100 at all. If just one of the early trials are positive, I think your timeline is almost a given and perhaps even conservative.
 

ChrizzlyAdams

Active member
@Jalu06 This is the regulary years end ponzi scheme. You better be not the last to jump on. Vyleesi is unmarketable. Pipline drugs if approved will have the same problem. Nearly no revenues. High cash burn rate which definitely is better than paying ridiculous dividends and doing saftey trials in various directions with half a dozen probands at the most.
 

Toktok

Well-known member
Uho over on GG connected some dots on the weird ACTH neuracthel story. He concluded it is possible that cuv could completely swap afamelanotode for ACTH on many of the current indications and speed up time to market. As a cheaper alternative to buying palatin and including their drug on the portfolio. As a faster alternative to try and get Scenesse approved for new indications.

Those who follow cuv from the beginning have surely noticed the deep reluctance of regulators to allow any progress with Scenesse. Demand an extra phase 3 trial, demand access to the us phase 2 trial. Endless delays after the dossier was filed. The FDA inviting patients, talking with the ema and wasting years in the process. Once approved they put draconian safety measures to confirm safety again and avoid any chance for off label. After years of safe and effective real world use still the vitiligo progress is glacial, all new trials and indications take ages to get approved.

I also think cuv and PW might have realised that any progress with Scenesse would take ages and therefore were on the lookout for already approved alternatives. Surely gives something to do for the marketing and branding department while waiting for Scenesse progress. The CEO is not getting any younger either. He said it will pay off in the end but surely he did not think the end would be so far away and the pay off so low.
 

sharelooker

Well-known member
@Toktok

Yes, very interesting thoughts by Uhonic! Patenting ndp-msh for the treatment of MS without clinical studies seems to be impossible, even with established MS models like EAE or Devic mice.

ACTH already has a footprint in MS and its safety is well known. However, the current formulation, which is gelatin based, must be administered daily for 2-3 weeks for acute MS relapses.

With neuacthel inst. and neuacthelle mod. they probably have a one time injection which releases the molecule over a period of 2-3 weeks for acute MS relapses or even longer for the long term treatment of MS.

If they really gave up on ndp-msh and decided to go on with acth, then the announcement of the new indication should be around the corner.
 
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macgyver

Well-known member
With neuacthel inst. and neuacthelle mod. they probably have a one time injection which releases the molecule over a period of 2-3 weeks for acute MS relapses or even longer for the long term treatment of MS
I agree, I’ve been thinking along similar lines regarding slow release. Too much ACTH can lead to complications i.e. Cushing’s disease, so the use of ACTH in such a fashion for existing MS patients to ease exacerbations seems an optimal way to go. But I’m dead set on afamelanotide being the primary drug for juvenile MS, mainly because it is the first disease in a line of neurodegenerative disorders Clinuvel hopes to treat IMO (e.g. AD, Parkinson’s and others). I haven’t caught up on research regarding ACTH in AD as an example, but in recent Google searches so far these neurodegenerative disorders are not something that normally appears in ACTH research, which I think points back to the limitations of ACTH and how overuse of the drug in the brain can potentially be harmful. (ACTH MC2R and Afamelanotide MC4R?)
However, with a name like ‘Neuracthel’, it does appears there’s a neurological aspect to the drug, and they do mention treating conditions with unmet needs as well so it will be interesting what they come up with. My bet is Neuracthel will be designed with the aim of alleviating existing symptoms, perhaps as an adjunctive to afamelanotide. An example might be Afamelanotide reduces inflammation in reactive microglia in AD, while Neuracthel strengthens the axions in nerve cells as part of an overall (holistic?) approach to treating AD.

Another aspect (and probably the most important) for using Afamelanotide as the primary drug in juvenile MS is really to further the commercial value of Clinuvel’s leading drug. ACTH has competitors, Afamelanotide does not (Where are you MT-7117?)👋

P.S. I believe Clinuvel said the new indication is the ‘final indication’ for Afamelanotide in the AGM presentation. I’m not sure what that means exactly, perhaps it’s the final medical field that will introduce a new indication from and then new indications introduced afterwards will be label extensions e.g. skin group, CNS group, and emergency events.
 
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Justinian

Well-known member
P.S. I believe Clinuvel said the new indication is the ‘final indication’ for Afamelanotide in the AGM presentation. I’m not sure what that means exactly, perhaps it’s the final medical field that will introduce a new indication from and then new indications introduced afterwards will be label extensions e.g. skin group, CNS group, and emergency events.
Perhaps that simply means it's the final indication they would submit to regulatory agencies for approval which would officially be on the label? At a certain point, off-label becomes a thing. Clinical trials or other data could support it's efficacy still, it's safety would already be widely accepted at that point, and it would be so widely used the price would probably have dropped quite a bit by that point.
 

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