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CUV, CLINUVEL PHARMACEUTICALS LIMITED
Frogster
post Posted: Aug 14 2018, 02:12 PM
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In Reply To: Johnny H's post @ Aug 14 2018, 01:31 PM

Over the years of being long CUV I've often wondered just how significant our collective tendancy to masochism is.
I guess it's a spectrum.
biggrin.gif .



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Dr Wolgen is a magician.
His end game for Scenesse will impress, or even amaze.
En route, along with glimmers of truth, there will be distractions, illusions, sleight of hand and misdirection.
Enjoy the ride.

Said 'Thanks' for this post: Verharven  
 
Johnny H
post Posted: Aug 14 2018, 01:31 PM
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In Reply To: xray's post @ Aug 14 2018, 11:57 AM

I'm not expecting much more for another 8 days. If the news comes sooner.... great!

Priority review guaranteed. If I'm wrong about that, every single member of sharescene who travels to Los Angeles in the next 6 months gets to kick me in the crotch as hard as they want. That's how certain I am.



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Clinuvel until my bowels release for the last time.

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xray
post Posted: Aug 14 2018, 11:57 AM
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After taking a break yesterday, the boys are back in town.
Lets see if they can pick up another 50,000 shares without cracking the $13 mark.

 
seeva222
post Posted: Aug 14 2018, 07:27 AM
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In Reply To: Johnny H's post @ Aug 14 2018, 04:30 AM

Amigos down too

 
Johnny H
post Posted: Aug 14 2018, 04:30 AM
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In Reply To: seeva222's post @ Aug 14 2018, 02:50 AM

Ionis has a competing drug for the same indication with a PDUFA date of October 6, 2018. Alnylam only has a 2 month head start.

I don't think they're going to get that $450,000 per patient per year that they're asking for.



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Clinuvel until my bowels release for the last time.

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seeva222
post Posted: Aug 14 2018, 02:50 AM
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In Reply To: Johnny H's post @ Aug 12 2018, 07:40 AM

And the stock dropped 8%... odd.

Stock price: ALNY (NASDAQ) $89.37 -8.00 (-8.22%)

 


seeva222
post Posted: Aug 14 2018, 02:50 AM
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In Reply To: Johnny H's post @ Aug 12 2018, 07:40 AM

And the stock dropped 8%... odd.

 
mrdax
post Posted: Aug 14 2018, 01:16 AM
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In Reply To: sharelooker's post @ Aug 12 2018, 12:33 AM

In which way do you think was it different beforehand?

 
Johnny H
post Posted: Aug 12 2018, 07:40 AM
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In Reply To: Desert Rat's post @ Aug 12 2018, 04:10 AM

Thanks! I don't get the dead tree version of WSJ, but I found it here:
https://www.wsj.com/articles/fda-approves-f...age=1&pos=1

Also of note in the article:
QUOTE
The FDA approved another rare-disease drug on Friday, Amicus Therapeutics’ Galafold for the treatment of the genetic disorder Fabry disease. The drug has already been on the market Europe. The FDA initially wanted Amicus to run another clinical trial that could have delayed U.S. approval for several more years, but last year reversed course and allowed Amicus to seek approval without a new study.






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Clinuvel until my bowels release for the last time.

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Desert Rat
post Posted: Aug 12 2018, 04:10 AM
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In Reply To: seeva222's post @ Aug 12 2018, 02:09 AM

Yesterday the FDA approved Alnylams first gene silencing drug Onpattro (patisiran) as a treatment for a rare type of hereditary amyloidosis which is caused by a genetic mutation in transthyretin synthesis. The specific approval was to treat the peripheral nerve disease caused by the buildup of amyloid, and the studies did not show whether it will change overall survival. Of note for afamelanotide, the Onpattro approval included outcomes based on improved ability to do daily activities.Onpattro is the first agent to use interfering RNA to silence a gene, something that has been done in the lab for over a decade, but delivery to cells in vivo was always a problem, now apparently solved. Hereditary transthyretin-mediated amyloidosis affects fewer than 5,000 people in the US and approximately 50,000 worldwide. And here's the kicker: the cost for the average US patient will be $450,000 annually, and about $345,000 after rebates, even though there is no data showing an increase in survival, or whether the effects can be maintained over years. I think this augurs well for the pending Scenesse review by the FDA. For reference, see todays (8-11-2018) Wall Street Journal, page B3 article by Peter Loftus.


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