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CUV, CLINUVEL PHARMACEUTICALS LIMITED
royco
post Posted: Apr 24 2019, 05:36 PM
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In Reply To: macgyver's post @ Apr 24 2019, 04:31 PM

We all expected feedback from the fda/cuv on labels and post marketing requirements
no later then April 8.
I guess this is it...
Gung ho!




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Ἀρτεμίσιον

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macgyver
post Posted: Apr 24 2019, 04:31 PM
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In Reply To: LevelHeaded2000's post @ Apr 24 2019, 03:38 PM

You missed a key sentence at the end of your quote which was:

QUOTE
Literally around the clock, our teams are collaborating with the FDA to answer the frequent queries arising from the scientific review process, such that a controlled post- licensing (post-marketing) follow-up of patients is put in place in the US.


Controlled post licensing follow-up? It seems to me that approval is imminent, of which the FDA accepted PW's proposal for the patient monitoring scheme a la "PASS" in Europe to get this either over the line or expedited for market release.

I'm not staking my reputation on it such as it is, but I think this drug will not be made available off-label. We'll see.


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LevelHeaded2000
post Posted: Apr 24 2019, 03:38 PM
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QUOTE
the Board of Directors hope to see the crowning glory of our objectives so far with the Company reaching a US Food and Drug Administration(FDA)approval through a New Drug Application .... Literally around the clock,our teams are collaborating with the FDA to answer the frequent queries arising from the scientific review process


I have stated before that I think the company is under expedited review. The intensity of the review process described by PW in his last letter and the confidence expressed by both PW and Stan make me believe this. It fits with the fact that the drug has a stellar safety record, it is already approved, and the FDA is trying to be more flexible with new innovative drugs.

If it is in fact under expedited review, then we would expect the outcome to come in 1 month prior than the stated date, so that means we could wake up to a positive decision as soon as June.



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epimatic
post Posted: Apr 24 2019, 03:29 PM
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In Reply To: LevelHeaded2000's post @ Apr 24 2019, 03:22 PM

calling it
bottom today $21.11

 
LevelHeaded2000
post Posted: Apr 24 2019, 03:22 PM
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In Reply To: Johnny H's post @ Apr 24 2019, 03:16 PM

The shorting of shares is getting bizarre to me. It is 30% off it's all-time-highs so it is not like someone can say it is looking extremely overvalued right now. Yet, we see relentless shorting. As you pointed out 250,000 shorted in the last two days. As of 4/16 the last day shortman lists for total shares shorted it is at > 400k which is an all-time-high for shares shorted. My guess is that it is at least > 600k now.

As to what would motivate someone to short the stock when it is low-liquidity and has a catalyst event I have no idea. In the last week 40% or so of total volume has been shorting. My guess is the shorter is just crazy. The good news is that these 600k+ shares will all need to buy back when this stock short-squeezes 100% on approval day.



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LevelHeaded2000
post Posted: Apr 24 2019, 03:17 PM
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Here is the newsletter for the interested: https://www.asx.com.au/asxpdf/20190424/pdf/...hwxgkd1yrm7.pdf
Attached File(s)
Attached File  newsletter.pdf ( 124.14K ) Number of downloads: 33
Attached File  newsletter.pdf ( 124.14K ) Number of downloads: 9

 


 


odi01
post Posted: Apr 24 2019, 03:17 PM
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https://www.asx.com.au/asx/statistics/displ...;idsId=02098450

 
Johnny H
post Posted: Apr 24 2019, 03:16 PM
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In Reply To: LevelHeaded2000's post @ Apr 24 2019, 03:04 PM

They changed up the website a little bit. It's here:
https://www.clinuvel.com/investors/news/announcements

As far as the "why did the price go down?!?!?", there were 150k shares shorted.

Count your eggs in July; until then it's a blood sport that no spectator can enjoy.



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Clinuvel until my bowels release for the last time.
 
Billy Boots
post Posted: Apr 24 2019, 03:13 PM
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In Reply To: LevelHeaded2000's post @ Apr 24 2019, 03:04 PM

Just go into your CUV share a/c and look under announcements.


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LevelHeaded2000
post Posted: Apr 24 2019, 03:04 PM
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In Reply To: Johnny H's post @ Apr 24 2019, 09:39 AM

Where is the newsletter? It is not published here: https://www.clinuvel.com/investors/news

 
 


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