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 >

4403 Pages (Click to Jump) V  < 1 2 3 4 5 > »    
 
  
Reply to this topic

CUV, CLINUVEL PHARMACEUTICALS LIMITED
seeva222
post Posted: Yesterday, 05:44 AM
  Quote Post


Posts: 1,210
Thanks: 1265


In Reply To: macgyver's post @ Yesterday, 04:17 AM

I didn’t determine that it was the FDA reading here, it was cause-and-effect. I believe they responded to something written here. I don’t think the chances are of great that it would happen but it doesn’t serve us in anyway to have an off label conversation. Clinuvel seems very careful about it’s wording around strict adherence to protocol.Even if the chance was .5%... why would you do it? I would follow their lead.

 
macgyver
post Posted: Yesterday, 04:17 AM
  Quote Post


Posts: 385
Thanks: 250


In Reply To: seeva222's post @ Apr 24 2019, 11:39 PM

Another conspiracy theorist. Proof? Or you heard from someone else? If you think the FDA will deny approval because off label is mentioned on ShareCafe then the whole approval system is detrimentally flawed, and the hard work, trials and treasure spent to get to this point will have been for nothing. That doesn’t make sense. I think it beneath you if you demean the people at Clinuvel and their hard work by insinuating that just the mere mention of off- label can destroy their efforts. I know your investment is precious to you but don’t let money cloud your sense of reality.


Said 'Thanks' for this post: scipio79  odi01  LevelHeaded2000  ironbark222  Dr Wally  
 
royco
post Posted: Yesterday, 02:57 AM
  Quote Post


Posts: 2,866
Thanks: 4353


In Reply To: scipio79's post @ Yesterday, 01:12 AM

The Ema pass data is crucial for cuv to understand its own product better.
It is probably better and more detailed then the actual trial data.
And it is an extra insurance for a safe development.
Some limitations with roll out and continued gathering of real life data will also make sense in the USA.



--------------------
Ἀρτεμίσιον
 
scipio79
post Posted: Yesterday, 01:12 AM
  Quote Post


Posts: 32
Thanks: 62


In Reply To: seeva222's post @ Apr 24 2019, 11:39 PM

I am not saying Clinuvel can't control it's own product, merely the FDA can't limit a doctor's professional judgment. I expect Clinuvel to limit itself, at least in the short term.


Said 'Thanks' for this post: royco  Dr Wally  
 
rabbitrun
post Posted: Yesterday, 12:05 AM
  Quote Post


Posts: 840
Thanks: 872


Annoying top-of-the-page ad you need to scroll past, but interesting read:

https://www.fiercebiotech.com/biotech/biote...s-behind-report


Said 'Thanks' for this post: johnnytech  
 
seeva222
post Posted: Apr 24 2019, 11:39 PM
  Quote Post


Posts: 1,210
Thanks: 1265


In Reply To: scipio79's post @ Apr 24 2019, 07:52 PM

Clinuvel is controlling the distribution. Drs can say what they want. Again, this isn't a helpful conversation given that the FDA frequents this board.


Said 'Thanks' for this post: Alaaf  
 


macgyver
post Posted: Apr 24 2019, 09:06 PM
  Quote Post


Posts: 385
Thanks: 250


In Reply To: scipio79's post @ Apr 24 2019, 07:52 PM

That’s interesting, I never thought about the doctor’s prerogative in prescribing medication and how the First Amendment might apply to that. I tend to view it the other way in that the drug company would have final say in how or where it’s drugs are distributed. However, it’s certainly possible that Clinuvel could set up the patient safety register and have the drug be available for doctors to prescribe off-label. It just doesn’t seem to gel with me though because of PW’s insistence on strict adherence to non-off label use.


 
scipio79
post Posted: Apr 24 2019, 07:52 PM
  Quote Post


Posts: 32
Thanks: 62


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

I am not sure the US First Amendment would allow such a restriction on commercial speech of doctors. There may be approved uses that clinuvel will abide by in its marketing, but the doctor would have a right to prescribe however he/she deemed professionally effective. That said, this area of law is not within my practice.


Said 'Thanks' for this post: royco  Dr Wally  oystercatcher  
 
IntiRaymi
post Posted: Apr 24 2019, 07:45 PM
  Quote Post


Posts: 55
Thanks: 39


In Reply To: juxtaposer's post @ Mar 22 2019, 12:13 PM

I meant to reply to this weeks ago, juxtaposer. No I didn’t do medical science at Usyd so wouldn’t have been me.

Glad I could help with the Avita tip though which is still going well. Clinuvel is the real baby though!


Said 'Thanks' for this post: juxtaposer  JoJa  
 
IntiRaymi
post Posted: Apr 24 2019, 07:36 PM
  Quote Post


Posts: 55
Thanks: 39


After my last buy before the recent big upwards movement to nearly AU$30 I wasn’t sure I’d see another buying opportunity so quickly. Got one again last night so happily topped up smile.gif

Thanks, Mr. Market!

 
 


4403 Pages (Click to Jump) V  < 1 2 3 4 5 > » 

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