Clinuvel

[Faultier]

Hi forum members,

beeing shareholder of clinuvel for some years now, I am following the company quite close as it is a significant position in my asset allocation.

Yet I am missing any meaningful opinion on a potential use of Afamelanotid for prevention or treatment of Covid-19. Given the number of patients being under treatment of scenesse I am assuming that there should be a significant number of person with Covid infections yet.

In context of global average numbers I'd actually expect at least 30 to 50 people who have had covid so far during the treatment with scenesse. Actually the number of identified cases should be even higher as the patients may be under much better medical supervision then average persons. Hence I'd assume covid to be diagnosed much more frequently under EPP patients than under average people.

Wondering what you guys thinking about it. May it be that this is the new indication? From my point of view covid would fulfill the requirements PW defined for possible indications and diseases in focus of clinuvel - at least there is a quite unmet clinical need I'd say.

Cheers

 

[investek]

@investek Determining the minimum number of people needed in a trial is part science and part 'black magic' in that certain fluid assumptions need to be plugged into the model. It all comes back though to if a study is sufficiently 'powered'. If you expect a large effect of your intervention, then you will need less people in the study to detect that potential difference. If the real-world effect was expected to be small, you would need lots more people to pick up that smaller difference in amongst the 'noise' of normal biological variation.

Power calculations are based normally around an 80% level, which roughly translated is the minimum sample size needed to give yourself an 80% shot of picking up a statistical difference if that difference is actually there. And then into the calculator you need an indication of the variance around the effect so that would normally be the standard deviation plus a call on what you determine as the meaningful clinical significance difference between groups. A weight loss trial that resulted in 0.5 kg of weight loss after one year could be statistically significant, but it is actually clinically insignificant.

The more people above this minimum level you get from a power calculation, the better. The big issue of running a trial underpowered is that if you don't see much of a difference/effect you really don't know if it was because the intervention did very little, or that the 'real' effect was hidden in the normal biological variation and study noise.

I've done a randomised controlled trial with just 18 people in it that was adequately powered (this is done before the study) because the intervention was expected to be very large in its effect - and it was! Hence the results and p value all were good. Yet a study could have 1,000 people in it and not be sufficiently powered if you are trying to pick up a very small intervention effect.

Summary: more patients are always better in a study (for the stats at least, cost and time is the downside), but it is utterly arbitrary to say that a study with 50 people in it is 'small' and one with 1000 is 'large' when the 'small study' could be adequately powered and the large one not.

Thanks @Verharven nice explanation.

I understand that the expected impact of the intervention can dramatically change the sample size required to obtain sufficiently powered results and I apologise for the blanket statement of wishing CUV were treating 1,000+ patients (I appreciate that is an arbitrary number).

If CUV were currently treating say XP patients instead of EPP patients I believe there would be enough historic data to demonstrate that SCENESSE prevents skin cancer and helps repair DNA in XP patients, as up to 10yrs of continuous treatment would have a massive impact on average life expectancy IMO (currently ~30yrs from my understanding) (Note: just my opinion, I don’t have anything more than the early EPT sunburn trials and hint of a result from OTR study to inform my view). As this is ‘treatment’ of a very severe condition and the potential change could be reduction in number of skin cancers or increase in lifespan I can understand how a limited number of people treated over years could yield very significant results.

Where I struggle is trying to think of an appropriate measure for effect (such as prevention of atherosclerosis, diabetes, skin cancer, CNS disease, etc) that SCENESSE may assist with and then being able to start making some high level assumptions to finally get an idea of required sample size.

 

[Clinhope]

Shorts climbing a little more from 4.77% to 4.81%.

 

[Samc60]

Shorts climbing a little more from 4.77% to 4.81%.
View attachment 2364

Its the only thing that is .... rising that is hihi

 

[Verharven]

@Samc60 Oh well, the consolation is that the last time shorts were at 4.82% it was March 23 and the SP was about $28 so they're still trying to pull themselves out of a hole by trying to lift up their legs.

 

[MrWalker]

Its the only thing that is .... rising that is hihi

Is that........green l see......

 

[ironbark222]

Heaps of XT trades

 

[Watene]

A bit more on my favorite topic... we need to remember that shorty has sale proceeds to the tune of over $50 million (2 million shares x $27 as a basic calculation). Given this, there is no way that this money is just sitting in a bank account ready to be used to buy back when the CUV SP is favorable . This will have been invested elsewhere and given the global markets are up this year, bound to be making money on something else. So when CUV SP started to get too high then the borrowers of CUV would start to get 'edgy' and would have limits as to when they would demand the stock back. I am sure they communicate this to the shorter/hedgie. No idea what that price would be when that would occur, but given the short attack, would suggest it was getting a tad too close for shorty. As you can imagine this process is repeatable for shorty, so long as they are paying the fees and interest on the sold shares and the price is at a place where the borrowers are comfortable, then they can keep on investing elsewhere and make money. Sobering eh.

 

[Toktok]

Are we clinuvellians actually all Truman Burbank?
What a show.

 

[Toktok]

Or are we lieutenant Drogo in the desert of the Tartars?

 

[macgyver]

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

US20200360484 NDP-MSH FOR TREATMENT OF INFLAMMATORY AND/OR NEURODEGENERATIVE DISORDERS OF THE CNS

<p id="p-0001" num="0000">The present invention is related to NDP-MSH or pharmaceutically acceptable salts thereof for therapeutic and/or prophylactic therapeutic treatment of inflammatory and/or neurodegenerative disorders of the CNS or multiple sclerosis. The present invention is further...

patentscope.wipo.int

https://patentscope.wipo.int/search/docs2/wipocase/r_f-LHmjMNbXQqLGTRuX_xlT7R8Fkx0fjL8BQdBCXEweVHl24auzc_ryvQE-im-u2z0Vep6Wboknn-M4K5OuwtU2YBCRFH3OG68u-sfqUYti6LM9kqzbnzZHVxSi-Co4GXUN2HLt_PzszwDBk1kfcX_gjFI4zhb2bsgEi08JBce3EGJutCihfvZdvbxtlwo3glWg-Oo6iBjQuAqIWLvpPn03M-88xWVrftnMcMCb_sjhb60DvJtfDN7SfVDEHx9VlTygys5jy2IB4BaysYdWv8hZtRyHl2cwzanaTZ5TZDf7AikJSdN8uCfuf-ivk6h-X279RY34krhnslZNQ4JqJw?filename=Applicant_Arguments/Remarks_Made_in_an_Amendment.pdf

Regarding a possible timeline for the Luger patent issue to be resolved: A letter of deferral/suspension was lodged around 23/11/21 by the Applicant which can run from 2 to 6 months. Then I think it takes approx. 3 months for a response from the Examiner. So by end of April 2022 at the earliest, Luger should know something. I assume if the Examiner gives their blessing, Clinuvel could go ahead and make the announcement for the new indication without having to wait for the offical paperwork to be finalised.

 

[Faultier]

Anybody aware if german Homm recommended to reduce the position in CUV on the 5th of Nov?

Just wondering as I am still receiving updates from him but only the headlines not the content. On the 5th Nov I received a mail "take profit" / "Gewinnmitnahme". Coincidence or was that a take profit for CUV shares?! Would explain the huge correction.