CUV, CLINUVEL PHARMACEUTICALS LIMITED

[Dr Wally]

In Reply To: Verharven's post @ Sep 23 2019, 01:17 PM

What could they possibly be seeing thats giving them the confidence to be betting against FDA approval in the face of all the positives? Strange!

That last delay when most thought FDA approval was a certainty has got to be behind their confidence. That and the history of Clinuvel and the attitude of the majority of regulators over the years. Maybe their sensing a EMA style debacle. 🤬

It’s going to be a strange feeling (after FDA approval) waking up without the uncertainty, wondering when Clinuvel will ever be allowed to move forward into the prosperous future that it deserves.

[Verharven]

In Reply To: Dr Wally's post @ Sep 23 2019, 12:58 PM

Look no further than the shorters to explain all this as the open shorts hit a new all-time high of 5.94% (2.906M shares) as of Tuesday of last week.

[Dr Wally]

I guess it doesn’t matter that much what the SP does (to a point) prior to FDA approval but the run up to the original PDUFA almost hitting $40 compared to now, with possibly 10 trading days left and the SP continuing to slowly fade away, it’s like night and day and makes little sense (to me😐): unless people are expecting more delays right?? How else could you explain this negativity right now?

With only days to go before the biggest, most definitive decision ever for Clinuvel and their proven beyond a doubt drug Scenesse, that for more then two decades has only ever produced positive data, with the FDA already having green lighted Bremelanotide (Vyleesi) almost identical Melanocortin: how could they even think of betting on anything other than a positive FDA outcome around October 6?

Unless you had inside information of further FDA nastiness/stupidity it’s a ludicrous position to take at this late stage of the game💀

[Billy Boots]

News report . Insider trading on the ASX . Hmmmmm.

[Frogster]

In Reply To: Johnny H's post @ Sep 23 2019, 09:03 AM

She will resign and stand for re-election at the upcoming AGM. You'll be able to vote on her appointment then.

Oh. Hold on.....

[Justinian]

In Reply To: Johnny H's post @ Sep 23 2019, 08:59 AM

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

[Johnny H]

In Reply To: Dr Wally's post @ Sep 23 2019, 08:59 AM

She has useful experience, which means free advice for Clinuvel. On the other hand, the experience is in the UK.

This is the second director in a row appointed and not elected. Not sure how I feel about that.

[Johnny H]

I talked to an FDA consultant this weekend, and I was told pretty much the same thing as everyone else.

If the PDUFA date is on a weekend, the FDA will communicate the decision after the end of the business day on Friday (which is Saturday in Oz).

Given Clinuvel's fondness for trading halts, I'm expecting a trading halt on a Monday, which would be today (ha! A man can dream), a week from today, or two weeks from today.


Reload ASX webpage. Wait 5 seconds. Reload ASX webpage again. Repeat until insanity.

[Dr Wally]

Sue Smith, to complement the Board. Good news? 👀

Mrs Smith’s specific expertise is in implementation of operational strategies within complex and acute care environments, and in the interaction with healthcare authorities and **UK regulators.**

[PunkassDerm]

Great personal story, Molecular biologist patient turned patient advocate!

Patient empowerment and access to medicines: Insights from a scientist-patient suffering from erythropoietic protoporphyria
Jasmin Barman-Aksözen
First Published August 6, 2019 Editorial

https://journals.sagepub.com/doi/full/10.11...399202619865167


According to the World Health Organization’s health promotion glossary, “empowerment is a process through which people gain greater control over decisions and actions affecting their health.”1


Patient representation during the evaluation of medicines by key decision makers such as regulatory agencies, Health Technology Assessment bodies, and healthcare payers is increasingly considered to add value to the appraisals and empowers patients, which means that they gain a more powerful voice over decisions and actions affecting their own health. As I myself suffer from the ultra-rare condition erythropoietic protoporphyria (EPP), I have participated as a patient expert in several discussions on access to afamelanotide, which currently is the only treatment for EPP and was approved in the European Union (EU) in 2014. As a molecular biologist with a PhD in EPP research, I consider myself having the necessary requirements to meaningfully contribute to such assessments. In this article, I share my personal experiences with regard to the discussions on access in Germany and England at the respective national competent authorities, the Federal Joint Committee, and the National Institute for Health and Care Excellence, respectively. In addition, I discuss the insights of the International Porphyria Patient Network, a group of highly empowered EPP patients effectively supporting national patient communities in their efforts to enable access to the afamelanotide treatment in their countries.

....

Having moved to Switzerland, I from 2012 on had the chance to test the afamelanotide treatment myself. Since a few minutes of exposure to sunlight can be sufficient to incapacitate me for days, I was naturally very cautious in the beginning and started with small steps like walking on the sunny side of the street or sitting on an “unsafe” seat in the bus that I knew would expose me to sunlight. Soon, I became more daring and attempted slightly riskier experiences—and made the same life-changing experiences as the other EPP patients I am in contact with. Today, under treatment, I am able to fully function in daily life: I can do my job in diagnostics, teach at the university, although the course is held in May and I have to travel to the other side of the city, and I can join social activities outdoors with friends and colleagues—sometimes I even find myself completely forgetting that I have EPP at all!