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CUV, CLINUVEL PHARMACEUTICALS LIMITED
NewToCli
post Posted: Mar 19 2019, 09:37 AM
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In Reply To: NewToCli's post @ Mar 19 2019, 09:04 AM

All sold down to 29.16....

 
Johnny H
post Posted: Mar 19 2019, 09:21 AM
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In Reply To: Verharven's post @ Mar 19 2019, 08:24 AM

CLVLY hit $21 USD today too.



--------------------
Clinuvel until my bowels release for the last time.
 
NewToCli
post Posted: Mar 19 2019, 09:04 AM
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In Reply To: Verharven's post @ Mar 19 2019, 08:24 AM

29.90 !


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Verharven
post Posted: Mar 19 2019, 08:24 AM
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Across the German exchanges, UR9 closed at EUR 18.77 ($29.97) and peaked at EUR 18.90. Reflected in the indicative open for the ASX now at $29.98


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investek
post Posted: Mar 19 2019, 07:35 AM
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In Reply To: rabbitrun's post @ Mar 19 2019, 03:06 AM

Extremely thankful!

Coincidentally(?) Scenesse may be therapeutic in diabetic retinopathy...
Credit to Uho for the info below.

QUOTE
Α-Melanocyte-Stimulating Hormone Protects Early Diabetic Retina from Blood- Retinal Barrier Breakdown and Vascular Leakage via MC4R
Conclusions: This study showed previously undescribed protective effects of α-MSH on inhibiting BRB breakdown and vascular leakage, improving electrophysiological functions and morphology in early diabetic retinas, which may be due to its down-regulating pro- inflammatory factors and augmenting tight junctions. α-MSH acts predominantly on MC4R to antagonize hyperpermeability in retinal microvessel endothelial cells.

https://www.karger.com/Article/Pdf/487029



Said 'Thanks' for this post: Doogieson  royco  
 
johnnytech
post Posted: Mar 19 2019, 05:08 AM
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In Reply To: royco's post @ Mar 18 2019, 08:33 PM

Royco, it does seem to put the horse in front of the cart to approve labeling in advance of approval, but the overall process is designed to include the minor details like this so the drug is marketable on July 8. As with all application approvals, the approval is effective immediately. Clinuvel can literally sell the drug same day as approval and thus all the details need advance sorting out.

Another example of this is last fall the FDA even added manufacturing inspections to the approval process (which we aren't affected by I think because of the timing of the policy announcement), which were previously a case by case detail or a later event like a health inspector might surprise inspect a restaurant.

As for any info conveyed to us in April, I have zero expectation that we will see an announcement. I hope we do because it keeps the stock going north, but that is secret private work product and no obligation to disclose.

 


Verharven
post Posted: Mar 19 2019, 05:04 AM
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In Reply To: royco's post @ Mar 18 2019, 08:33 PM

I wouldn't put too much significance on the July 8 date as this is more an aspirational target for the FDA. From data I posted previously, based on the last 3 years, the median approval time for a priority review was 8 months and ranged from just over 90 days to almost 2 years so I would treat the 8 April as the starting point where news could arrive 'any day'. Considering the FDA has had many years to take a look at Scennesse under the rolling review and it has EMA approval I am mildly optimistic that it could be a shorter review time.

 
rabbitrun
post Posted: Mar 19 2019, 03:06 AM
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So easily this could have been us. Thankfully, we’re on a different path.

https://www.fiercebiotech.com/biotech/aerpi...-eye-study-flop


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IntiRaymi
post Posted: Mar 18 2019, 09:29 PM
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In Reply To: royco's post @ Mar 18 2019, 08:33 PM

What if, Royco, the labelling decision is made these three months in advance of the July decision for IF there is approval? I.e these are the parameters put in place should the drug be allowed to come to market. Maybe this kind of documentation is quite trivial and easy to produce


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sharelooker
post Posted: Mar 18 2019, 08:59 PM
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BTW the new Acting FDA Commissioner was a co-founder of a biotech called Sapere Bio that focuses on cell-aging and senescence.


Said 'Thanks' for this post: odi01  NewToCli  royco  investek  johnnytech  Doogieson  
 
 


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