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CUV, CLINUVEL PHARMACEUTICALS LIMITED
Verharven
post Posted: Today, 01:39 PM
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Showing how meaningless really daily gross shorts are, open shorts just fell from 5.22% to 2.76% as of August 13 when gross shorts for that day were 78k.

 
johnnytech
post Posted: Today, 09:13 AM
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In Reply To: Justinian's post @ Today, 07:15 AM

I'll be honest, I don't know. I've largely stopped my FDA research because Johnny H and Farmazutical took over the heavy lifting. My guess is though we won't hear from FDA publicaly since we are in the quiet period. However, I also don't understand how Johnny H got materials during this time through an FOIA request, because congress has given FDA exception clauses to FOIA requests during quiet periods. So, I'm not confident saying we won't hear, but I'm guessing not. Of course, Clinuvel may tell us but that's a nice roll too.

 
Johnny H
post Posted: Today, 08:41 AM
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In Reply To: Justinian's post @ Today, 07:15 AM

It's not a meeting so much as it is a response to what Clinuvel has proposed, and the response will be in writing. Clinuvel provides a proposal on post-marketing in the initial NDA, and the FDA provides commentary on the proposal, if necessary.

See page 10 of attached FDA guidance on how to submit an NDA.

Clinuvel is not required to provide any notice to shareholders whatsoever, although I'd be highly suspicious if they didn't.

By the time we get to post-marketing, it's pretty much a done deal. The FDA isn't going to waste time on labeling and post-marketing if they aren't going to approve it first cycle. A CRL would focus on actual deficiencies rather than a hypothetical approval.
Attached File(s)
Attached File  4000.4_Rev_1_cleared_by_OCP_OTS_ORP.pdf ( 307.45K ) Number of downloads: 10

 




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Clinuvel until my bowels release for the last time.

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NewToCli
post Posted: Today, 07:25 AM
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In Reply To: Justinian's post @ Today, 07:15 AM

Well I guess Clinuvel will get the info first, then they will put a trading halt and announce the decision later / the next day.

Price will gap up, shorties will be in blank panic and buy back anything they can get.

Ah, i guess if the approval comes earlier it will be not very much planned / scheduled but be ok short notice or maybe together with the marketing requirements. I wouldn’t think that Cuv gets an info beforehand that the decision is coming earlier


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Justinian
post Posted: Today, 07:15 AM
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In Reply To: johnnytech's post @ Today, 07:10 AM

Does Clinuvel have to announce the planned September meeting when If happens? I know some of us were wondering about that back in June, if the meeting happened or not (but obviously didn’t).


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johnnytech
post Posted: Today, 07:10 AM
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In Reply To: Farleap11's post @ Yesterday, 05:52 PM

Farleap, last year I shared a Google sheet of all 2017 fast tracked drugs. 17 drugs in total. The goal was to see the differential of actual approval vs PDUFA date. Below is the column of the 17 differentials. These numbers are rounded to within 1/2 month increments. -1 means approval came one month before PDUFA date. As you can see, we have a fair chance of coming early or on time. Out of 17, only 2 were late.

-2, -2, 0, 0, -1, 0, -0.5, 0, 3, 0, 0, 2, 0, -3, -0.5, 0, -1


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Frogster
post Posted: Yesterday, 09:43 PM
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In Reply To: Clinhope's post @ Yesterday, 09:29 PM

I don't disagree that Fda approval would be of seismic magnitude, but I do think that if there are ambitions to be a broad based company, simultaneous progress on parallel fronts is not an unreasonable thing to expect. I just hope they been doing something in this vein and not (yet) telling us about it.



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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.

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Clinhope
post Posted: Yesterday, 09:29 PM
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Because it is an event horizon. Our future relies so heavily on the outcome of the FDA decision that thinking beyond that point is as much speculation as trying to answer what will the world be like once General Artificial Intelligence is created? We can guess and we can prepare for likely scenarios. But ultimately, the answer to what action we take or the outcome of our future will only be unveiled when we reach the event horizon.



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Member of the “ALL-IN” club 2018.

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Frogster
post Posted: Yesterday, 09:05 PM
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In Reply To: NewToCli's post @ Yesterday, 08:55 PM

Agreed. There is So MUCH stuff that has gone dark since the Fda application delays/extensions that we might hope for a whole raft of newsflow after any approval.

Regarding VP, that was due to start European spring, with 6 or 8 month follow up (can't remember the precise detail) so that should be ongoing.

There should have been another indication announced early this year. What's going on with paediatric scenesse? Where are the oft referred acquisitions....... Etc etc.

I get that some stuff strategically relies upon fda approval. I'm not sure I get why everything seems to be waiting for it.



--------------------
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: NewToCli  
 
NewToCli
post Posted: Yesterday, 08:55 PM
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Maybe we need to think a step further as fda approval. Approval is very likely and we shouldn’t doubt it anymore. The market partly also priced in approval with a high probability (prices above 32 aud). To continue the stock price rally the questions are further then just approval
- what will happen after that? How long does it take to materialize profits? What’s now with the other indications? How is Cuv going to scale the Scenesse platform? What happened with VP trial? any progress in topical? Etc etc ... I think the path forward even with approval is not very clear to the market... and keeping everything secret and slow doesn’t help anyone in the end. Why do they register trademarks and then not use them for years? Etc etc


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