Registered Members Login:
   
Forgotten Your Details? Click Here To Recover +
Welcome To The ShareCafe Community - Talk Shares And Take Stock With Smart Investors - New Here? Click To Register >

4573 Pages (Click to Jump) V  < 1 2 3 4 5 6 > »    
 
  
Reply to this topic

CUV, CLINUVEL PHARMACEUTICALS LIMITED
lion40
post Posted: Yesterday, 03:13 PM
  Quote Post


Posts: 5
Thanks: 5


In Reply To: Johnny H's post @ Yesterday, 08:41 AM

is this Material (Effective Date: 09/23/2016) important?
i mean Clinvuel has always informed us...

 
bretto32
post Posted: Yesterday, 02:45 PM
  Quote Post


Posts: 49
Thanks: 23


In Reply To: Johnny H's post @ Yesterday, 02:33 PM

what I meant was the drop. the short position dropped 1.2 million shares in one day with volume nowhere near those levels.

 
Johnny H
post Posted: Yesterday, 02:33 PM
  Quote Post


Posts: 660
Thanks: 1024


In Reply To: bretto32's post @ Yesterday, 02:05 PM

ASIC is showing 2.76% as of August 13, for a total of 1.35 Million shares.

https://asic.gov.au/Reports/Daily/2019/08/R...AggShortPos.pdf


At the top:
"Disclaimer: No responsibility is accepted for any inaccuracies contained in the matter published."






--------------------
Clinuvel until my bowels release for the last time.
 
bretto32
post Posted: Yesterday, 02:05 PM
  Quote Post


Posts: 49
Thanks: 23


In Reply To: Verharven's post @ Yesterday, 01:39 PM

Is that an error? Thats 1.2 million shares.

 
Verharven
post Posted: Yesterday, 01:39 PM
  Quote Post


Posts: 741
Thanks: 1833


Showing how meaningless really daily gross shorts data is, open short positions just fell from 5.22% to 2.76% as of August 13 when gross shorts for that day were 78k.

 
johnnytech
post Posted: Yesterday, 09:13 AM
  Quote Post


Posts: 401
Thanks: 732


In Reply To: Justinian's post @ Yesterday, 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: Yesterday, 08:41 AM
  Quote Post


Posts: 660
Thanks: 1024


In Reply To: Justinian's post @ Yesterday, 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: 28

 




--------------------
Clinuvel until my bowels release for the last time.

Said 'Thanks' for this post: Frogster  Justinian  johnnytech  
 
NewToCli
post Posted: Yesterday, 07:25 AM
  Quote Post


Posts: 659
Thanks: 1224


In Reply To: Justinian's post @ Yesterday, 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


Said 'Thanks' for this post: Clinhope  
 
Justinian
post Posted: Yesterday, 07:15 AM
  Quote Post


Posts: 230
Thanks: 352


In Reply To: johnnytech's post @ Yesterday, 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).


Said 'Thanks' for this post: Johnny H  
 
johnnytech
post Posted: Yesterday, 07:10 AM
  Quote Post


Posts: 401
Thanks: 732


In Reply To: Farleap11's post @ Aug 18 2019, 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


Said 'Thanks' for this post: Justinian  NewToCli  Johnny H  Verharven  KRD  odi01  
 
 


4573 Pages (Click to Jump) V  < 1 2 3 4 5 6 > » 

Back To Top Of Page
Reply to this topic


You agree through the use of ShareCafe, that you understand and accept the TERMS OF USE.


TERMS OF USE  -  CONTACT ADMIN  -  ADVERTISING