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CUV, CLINUVEL PHARMACEUTICALS LIMITED
rlfergu
post Posted: Today, 10:33 AM
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I first heard about epitan (CUV) in the late 90s when I was watching a show called Scientific American Frontiers. It was hosted by Alan Alda. Does anyone remember this episode? Alan was interviewing the Doctors at the university of Arizona right after they starting to take the drug them self's.

 
Verharven
post Posted: Today, 10:33 AM
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Some more coverage from the Motley Fool

https://www.fool.com.au/2019/01/18/why-the-...-the-past-year/

Why the Clinuvel share price is up 150% over the past year

The Clinuvel Pharmaceuticals Limited (ASX: CUV) share price is now up around 150% over just the past year after rising from $8.89 this time last year to $22.13 today.

Clinuvel is a global biopharmaceutical company that develops treatment for severe and genetic skin disorders that has produced a drug named SCENESSE.

It reports the drug is on the verge of approval by the US drugs regulator the FDA. According to the company the FDA is set to communicate labelling and post marketing requirements for the drug in April 2019, with July 8 2019 a potential final review date that could see the drug approved assuming the FDA’s final hurdles for the drug are all cleared.

The SCENESSE drug has already been commercialised in Europe (approved in 2014) with total sales from customers hitting $10.75 million for the quarter ending September 30 2018 to produce an operating cash profit of $7.8 million. The pharmaceutical also had $44.4 million cash on hand at September quarter end to suggest its well funded for further research ahead.

Clinuvel now has a market value of more than $1 billion and the stock has been rising as it moves closer to FDA approval that could send its sales and profits soaring.

However, investors should remember FDA approval is never guaranteed, as pharmaceutical manufacturer Starpharma Ltd (ASX: SPL) recently showed, after its application for a clinical gel product approval was knocked back by the FDA.


 
royco
post Posted: Yesterday, 10:58 PM
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In Reply To: Verharven's post @ Jan 17 2019, 04:48 AM

https://www.bogleheads.org/wiki/John_BogleJohn C. (Jack) Bogle (1929 - 2019), after whom the Bogleheads® are named, was founder of the Vanguard Group and creator of the world's first retail index mutual fund.



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Ἀρτεμίσιον
 
macgyver
post Posted: Yesterday, 07:37 PM
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In Reply To: NewToCli's post @ Yesterday, 04:56 PM

Thank you for your reply. That is great news patients can be administered 6 implants and that they can be reimbursed. I’m surprised it wasn’t mentioned in the recent newsletter, perhaps it is just a formality that was going to happen sooner or later and immaterial compared with the FDA PDUFA announcement.

Hopefully Düsseldorf will have the means in 2019 to cater for those waiting for relief.


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NewToCli
post Posted: Yesterday, 04:56 PM
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In Reply To: macgyver's post @ Yesterday, 09:13 AM

From the patient community it is recommend to administer 6 implants. In some centers I Europe they already do it. I all implants are reimbursed, no matter if 4 or 6. The Centre in Düsseldorf is at it capacity limit and they always plan treatment for the whole year. The patients are on a waiting list and they call them to arrange the appointments, but not all patients can be treated yet due to capacity and bureaucracy

 
johnnytech
post Posted: Yesterday, 04:40 PM
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In Reply To: Verharven's post @ Yesterday, 03:12 PM

This is perfectly normal activity. On July 8 Clinuvel will receive a positive "market authorization letter". What we call approval. The package gets down to the nitty gritty of what the label looks like and the words Clinuvel is to use to go to market.

Too bad the FDA can't disapprove the company logo.


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Verharven
post Posted: Yesterday, 03:12 PM
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So something that hasn't really been discussed is this from the recent PDUFA announcement that "the FDA expects to communicate labelling and post-marketing communication labelling - if needed - by 8 April 2019". Does anyone know if this is a normal part of the leadup to PDUFA decisions as seems like a positive indication if it has been mentioned by the FDA and if not normally part of the process?

 
Verharven
post Posted: Yesterday, 12:50 PM
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In Reply To: waz's post @ Yesterday, 12:20 PM

Gross shorts for Tues, Wed and Thursday this week have just been 2-3k each day. Would be a brave person to go hard on shorting this now with the price stable and firm event milestones now for the next 6 months.


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waz
post Posted: Yesterday, 12:20 PM
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Shorter capitulation on Monday. Shorts reduced a net 56k from 171k to 115k. As suspected by many short covering caused the price spike up to $22.71.

https://www.shortman.com.au/stock?q=cuv

Will be interesting to see short covering volumes after Monday in 'shorts' reportings next week.


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oystercatcher
post Posted: Yesterday, 11:45 AM
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In Reply To: macgyver's post @ Yesterday, 09:13 AM

Your not alone and valid questions
Would appreciate an answer to those questions please
Cheers to all

 
 


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