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CUV, CLINUVEL PHARMACEUTICALS LIMITED
mrdax
post Posted: Feb 16 2020, 11:28 PM
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In Reply To: investek's post @ Feb 16 2020, 07:12 PM

Interesting that a Mr Langsam, which translates to "slow" in German, speaks about PW 🤷🤣

 
sharelooker
post Posted: Feb 16 2020, 09:41 PM
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Dr Boreham’s Crucible: Why CSL is the poster child for most junior drug developers
https://stockhead.com.au/health/dr-borehams...rug-developers/

QUOTE
So how do you pick the next CSL? You probably can’t, although holders in the runaway $1.3bn drug developer Clinuvel (ASX:CUV) may feel they are onto the next big thing
biggrin.gif





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investek
post Posted: Feb 16 2020, 07:12 PM
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Alan Kohler speaks with Editor of Biotech Daily, David Langsam
https://www.eurekareport.com.au/investment-...005759#Clinuvel

This interview is behind a paywall but you can sign up for a free trial, not sure it’s really worth it...

Interesting that Wolgen talked up Langsam so much at the AGM yet Langsam never invested in CUV and seems to have some issues with the facts he presents...

Some snippets:
DL - I think Clinuvel put out a dividend this year. It’s very un-biotechy to pay a dividend.
AK - Indeed, I asked the CEO of Clinuvel why the hell they do, what’s the point? It was such a small dividend, it didn’t seem much point.
DL - Well, it’s something back to the shareholders.

DL - I know a lot of investors have been waiting for it to go off-label, but Philippe Wolgen’s job in getting through the EMA, the FDA and now an application to the Australian TGA, has been nothing short of heroic. I fully applaud him. And we don’t have many successes. I think before Clinuvel getting FDA approval, the only one that went all the way was Chemgenex with OMAPRO for Leukemia and that was taken up by Teva and the last bit of the approval was undertaken by Teva Pharmaceuticals which is a giant. Technically, I think Clinuvel is the first Australian to go all the way through the FDA on its own.

DL - I’ll just go back to Clinuvel for a moment. Clinuvel charges $10,000 dollars or thereabouts per dose. This old drug which is close to being off patent, to get it injected into your arm pit to give you that darkening of the skin for the EPP disease that causes so much pain, it costs $10,000 dollars per injection or thereabouts.

(My comments: I’d say the price is closer to $20kAUD per implant and where is he getting the armpit info as the injection site?!)

AK - Okay, so just finally, what are your favourite biotechs at the moment? You’ve been talking a lot about Clinuvel, so I guess that’s one of them?
DL - Well, it’s one that I didn’t invest in and I should’ve. In hindsight it’s a wonderful thing, isn’t it, Alan, the ones that I didn’t buy?


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Farleap11
post Posted: Feb 16 2020, 03:20 PM
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In Reply To: Farleap11's post @ Feb 16 2020, 03:15 PM

One important extract that I unfortunately omitted was that Justice Hammerschlag will announce his decision on damages in the case on March 6 !!!!!!!


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Farleap11
post Posted: Feb 16 2020, 03:15 PM
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There is an interesting article published in the “Wealth” section of the W/E Australian newspaper relating to a current case in the NSW Supreme Court dealing with Short Selling. The title of the article by James Kirby, Wealth Editor reads, “Big super funds’ short cuts in the dock”. Relevant extracts are as follows:

[i]“Big super funds that finance short-selling — especially industry funds that strive to take the higher ground in ethical investing — must surely be wincing at a remarkable story in the courts this week surrounding one of the nastier “short attacks” we have ever seen in Australia…………………………….

In principle, shorting keeps the share market healthy. It spots weakness and, at its best, forces companies to clean up their act…… But how short funds actually work in practice is another matter altogether: a court judgment this week would seem to confirm our worst fears about shorts and how they operate in practice……………………………………

There has always been rumours that short-sellers play various tricks: using media leaks as part of shorting campaigns, exaggerating weaknesses of the target to maximise profits, etc. But we now have a window into what can be a decidedly unsavoury business after a plucky decision by Rural Funds Management to take its enemy — a US short-selling specialist called Bonitas Research — to court.

Rural Funds management CEO David Bryant woke up one morning last August to find the Texas-based short fund had issued a damning report on the Australian business, branding it as “worthless”.
Now in our volatile and overheated share market, a report like that spreads like wildfire and other investors don’t wait around to see if Bonitas has played by the rules or not — many investors simply sold out. Rural Funds endured a 42 per cent fall in its share price in the -aftermath of the report release.

Why? Because Australia has been a short-sellers paradise since the original attacker, Glaucus, came in some years ago and made a fortune with a masterpiece short attack on sandalwood plantation group TFS and followed it with an even bigger trophy, the Blue Sky group. In both cases, the companies literally crumbled and Glaucus made a fortune...………..At any given time, there are hundreds of stocks being shorted — over the last week among the top 10 most shorted were JB Hi-Fi, the Inghams group and tech favourite Nearmap. The most shorted stock in the entire market is miner Galaxy Resources, with nearly a fifth of its entire market capitalisation held by shorts. But the “short attack”, where there is a concerted effort to damage a company with a blitz of negative reports coupled with strong publicity, is a relatively new development…………….

On Wednesday, Justice David Hammerschlag in the NSW Supreme Court gave Bonitas a beating around the ears that was something to behold. Hammerschlag said the Bonitas report on Rural Funds was “materially misleading” and then he hit them between the eyes with this: “They (Bonitas) never took the trouble to check with or inquire as to any material which they broadcast … I have no difficulty in concluding that they did not care whether what they were saying was false.”...………..As a precautionary measure, Bonitas fired off an email to their Australian target that revealed the Bonitas researchers had never visited Australia and they were sure the laws of the US would protect them should Rural Funds be so presumptuous as to try to defend itself………….Meanwhile, Rural Funds’ share price — at $2.05 — has recovered to a point close to where it was the day Bonitas launched its attack...……...
If the Rural Funds exercise ends up costing Bonitas big money in damages, it will change the numbers for anyone considering a short attack on Australian companies. Or, to be precise it will change how shorters behave in our market — and that would be no bad thing.”
[/i]

Given the levels of interest previously posted on this very topic, I felt it worth sharing.




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macgyver
post Posted: Feb 16 2020, 06:59 AM
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In Reply To: sharelooker's post @ Feb 15 2020, 07:57 PM

That would perhaps explain the delay in filing a dossier with the French authority. I wonder if Clinuvel could appeal the Spanish decision with new safety data. Or the Scandinavian countries for that matter. Im not sure it has been safety or efficacy that are the main determinants when various authorities have assessed Scenesse, I figure it has been purely economic reasons thus far.

 

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sharelooker
post Posted: Feb 16 2020, 06:51 AM
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A very good publication re the market access of orphan drugs in france.

QUOTE
At the time of our study, 78.3% of the registered orphan drug–therapeutic indication pairs were marketed in France. In a survey conducted and published by EURORDIS in 2010 [2], 90% of the studied orphan drugs were available in France.


https://ojrd.biomedcentral.com/articles/10....3023-019-1026-4


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sharelooker
post Posted: Feb 15 2020, 09:12 PM
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Some reviews about vylassi. In my opinion, this drug should be withdrawn from market asap!

https://www.everydayhealth.com/drugs/vyleesi/reviews


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sharelooker
post Posted: Feb 15 2020, 07:57 PM
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In Reply To: investek's post @ Feb 15 2020, 06:56 PM

Thanks, mate!
It's great to see CUV on the same list with big players like NVS, AMGN, SNY and their high-price drugs Kymrieh, Kisquali etc. Hopefully, the patient testimonies and the additional Real-World-Data on efficacy and safety will have a positive impact to the decision.

QUOTE
In France, Italy, and Spain, conditional approval significantly decreased the odds for reimbursement, which suggest that the decision-making body in those countries waits for further data on efficacy or safety (the EMA, after providing conditional approval, requires the applicant to provide further data within the agreed time frame)



Reimbursement of Orphan Drugs in Europe in Relation to the Type of Authorization by the European Medicines Agency and the Decision Making Based on Health Technology Assessment
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6240661/

 
investek
post Posted: Feb 15 2020, 06:56 PM
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In Reply To: sharelooker's post @ Feb 14 2020, 01:08 AM

Thanks sharelooker, some awesome contributions from you lately! Also I forgot to give you the credit for the recent Singapore employee Peiyan YU find when I posted it, thanks again.

Re: Alnylam and their pricing/ reimbursement strategy the one element I can see Wolgen adopting for negotiations with NICE is a patient population cap. I think there is a fair argument that the total cost of treatment should not exceed say 20mil pounds in the UK (assuming say 400 patients at 4 implants per year). I can imagine discussion/debate on patient population (is it actually 400 or should it be 200, worst sufferers), and should it be 4, 6 or only 3 implants per year however the one area I don’t see Wolgen giving an inch is on the price per implant. I believe he will stick firmly to the uniform price.

I’m interested in people’s views of the potential upside from France and/or UK, conservatively I see about $160mil AUD addition in enterprise value from the addition of each country.

Approx EPP patient populations from memory UK ~400, France 286.



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