Clinuvel

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investek

Well-known member
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SBB

Member
Spotted broker comment on yesterday's markets noting Biogen (-1.8%) got a headache as their Alzheimer drug shows brain swelling in a third of patients

Quick search on the FT showed up this from last week (apologies if noted earlier on the forum)

A key European Medicines Agency panel has signalled it is unlikely to grant approval to Biogen’s drug for Alzheimer’s disease, adding to the debate surrounding a controversial treatment that retails at $56,000 a year.

On Wednesday, Biogen said Aduhelm, the drug it has developed with Japan’s Eisai, received a “negative trend vote” from the Committee for Medicinal Products for Human Use panel on its application for marketing authorisation in the bloc. The panel is expected to give its formal decision next month, Biogen said.


Quite a few here suspect that the long-awaited next indication will be AD. And, back at the time, that approval of Aduhelm didn't reflect well on the FDA process.
 

Toktok

Well-known member
With Swiss patients non stop using scenesse and some EU patients since 2016 without interruption cuv and ema must be able to see some other health benefits in the data compared to the population averages.

The question is are they measuring any of these peripheral beneficial side effects? If Scenesse has preventative/protective/DNA repair effects the fact not to measure any cases is relevant but only visible when compared to what happens in the total population.

Was there ever an EPP patient on scenesse with an AIS? How this number compares to the population expected average? EPP patient survival/recovery rate should be significantly higher while incidence should be much lower.

Was there ever an EPP patient on scenesse diagnosed with severe DNA damage and subsequent skin cancer or precursors? Again should be very close to zero and probably atypical compared to the number for the total population.

Was there ever one EPP patient on scenesse diagnosed with AD, PD or MS? What are the odds if you would take a random group of 1000 people? Clinuvel, ema or the hospitals/patients should be able to see something already.

Was there ever an EPP patient on scenesse diagnosed with COVID-19? How did they survive/recover?

Did any EPP patient have also vitiligo? Did it go away for those diagnosed with vitiligo? Did any develop vitiligo while on scenesse? How many cases would you expect in a normal population of 1000 random people?
 

Justinian

Well-known member
@Toktok Should definitely be useful data there. But for things like skin cancer, people with EPP avoid sunlight for most of their lives so they probably already have a much lower incidence of skin cancer.
 

macgyver

Well-known member
The saga continues!

Luger submitted an extension for the CNS patent on 15/11/21. New claims were added removing references to MS and replacing them with statements that symptoms were ameliorated by the data from the EAE mouse models - inflammation and neurodegeneration of the CNS.

Further, Luger’s lawyer points out in two previous non-final rejections the Examiner said Devic’s disease was highly similar to MS and that some of the most successful MS therapies to date have originated from the EAE mouse models. However, in the final rejection the Examiner said the EAE model is an unreliable predictor of efficacy in the treatment of MS. The Examiners have painted themselves into a corner😉


 
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Alexius

Well-known member
@macgyver
Is this the same patent as the one where Luger apologized to PW in writing and granted him ownership of the patent? This Luger dude should finally let it go and leave the field to PW/Clinuvel! He himself has no possibility to make this potential treatment available to the patients in need. Therefore his actions are highly unethical imo. To put it in Mac's words: Be gone, Lord of the Flies! 🐝
 
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polyphemus

7th Longest Active Member
@macgyver Thanks . I don't think it matters any more, but it will be good once clarity is achieved for afamelanotide, as I would say CUV has a few indications they would like to treat pre-emptively. NeurACTHel will do the job for now - ACTH is standard treatment for MS post exacerbation. CUV brings formulation, eventual supply and simplified delivery improvements. I would believe that this time next year, Clinuvel will not only say its world leader in skin and light conditions, but also DNA repair, and neurological disorders and vascular disorders.
 
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