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CUV, CLINUVEL PHARMACEUTICALS LIMITED
Johnny H
post Posted: Oct 1 2018, 06:24 AM
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In Reply To: macgyver's post @ Oct 1 2018, 05:29 AM

No, it was an offer that was too good to refuse.



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Clinuvel until my bowels release for the last time.
 
macgyver
post Posted: Oct 1 2018, 05:29 AM
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In Reply To: Johnny H's post @ Oct 1 2018, 04:31 AM

$120?

 
Johnny H
post Posted: Oct 1 2018, 04:31 AM
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In Reply To: macgyver's post @ Sep 30 2018, 03:12 PM

PR guaranteed.

My original offer still stands.



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Clinuvel until my bowels release for the last time.
 
macgyver
post Posted: Sep 30 2018, 03:12 PM
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In Reply To: Dr Wally's post @ Sep 30 2018, 01:18 PM

I’m ready for no PR, I expect it actually. Preferably PR is ideal but I can wait. The only thing that would be irritating is dragging out the NDA past it’s 10-12 month timeline as what happened in Europe. This time around there is no excuse to drag it out, there are very clear guidelines that the reviewers follow and the benefit of the doubt should be given to Clinuvel concerning efficacy due to patient retention and safety profile. To go beyond the timeframe is inexcusable.

The odds are not in favour of Clinuvel due to zero percentage of PRs issued from the FDA’s Dermatology and Dental department. Though in saying that, I couldn’t tell you what kind of indications and their severity PR was applied for previously. EPP might very well be a first due to the severity of it but I would be surprised if it was the first of its kind to gain PR. Opportunity for research...

If PR is granted, I’d take that as an approval and I think the market will respond accordingly in the positive.


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Clinhope
post Posted: Sep 30 2018, 02:06 PM
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In Reply To: scipio79's post @ Sep 30 2018, 09:15 AM

Also being used for treating vitiligo. I stumbled across this while looking into recell. http://3af4pk1d7ktnf8ieb2pl91t1.wpengine.n...es-in-China.pdf



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Member of the “ALL-IN” club 2018.
 
Dr Wally
post Posted: Sep 30 2018, 01:18 PM
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In Reply To: Boat2float's post @ Sep 30 2018, 12:46 AM

I’d like to hear what the good people that invested in the early 2000s would think about things “just getting started”? 😟
FDA approval is the beginning of a decade at least of strong growth so hopefully the realisation of that will provide a little consolation for the two decade wait. 🙂

No FDA PR will be so disappointing though for numerous reasons. For me, it’ll be the strongest of indications that US regulators are continuing to struggle (even at this late stage in 2018🤬) to get their heads around the game changing drug that stimulates a natural photo protective “tan”. . If PR is rejected you’d have to think that these guys will unashamedly be prepared to drag things out to the bitter end and 2020 could be a real possibility as unpalatable as that sounds.

Alternatively the FDA have accepted that Afamelanotide will provide a multitude of health benefits to millions of people and that trumps an irrational fear of unbridled tanning bringing about the end of the world. 😑 If drug safety is as sacrosanct as I think it is, if logic, common sense and science prevails , Clinuvel will see a PR and approval 6 months after that. That day will be a momentous day even if the market takes a week or so to realise the implications of that decision.



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Any price pre FDA approval will be seen as an absolute bargain within 2-3 years. 🙂

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scipio79
post Posted: Sep 30 2018, 09:15 AM
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In Reply To: IntiRaymi's post @ Sep 30 2018, 05:53 AM

https://pressreleases.responsesource.com/ne...s-demonstrates/
Could be a very promising stock.


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johnnytech
post Posted: Sep 30 2018, 08:54 AM
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In Reply To: IntiRaymi's post @ Sep 30 2018, 05:53 AM

I'm interested in other NDA drugs. Can you give us a quick summary of what Avita Medical's stock price did over the last year during key events like NDA submission day and leading up to the PDUFA date, pre and post approval announcement. Did the company keep things to themselves, or were they open throughout the process? Thanks.

 
IntiRaymi
post Posted: Sep 30 2018, 05:53 AM
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In Reply To: odi01's post @ Sep 30 2018, 03:59 AM

Interesting the mention of Avita Medical in that article. They just received FDA approval last week. I’m also invested in them too thinking that their re-cell technology could be a game changer in the burns and cosmetic market and often wondered if alongside Scenesse it could have amazing cumulative effects with vitiligo..


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odi01
post Posted: Sep 30 2018, 03:59 AM
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https://www.smh.com.au/money/investing/elli...928-p506kx.html


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