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 >

4281 Pages (Click to Jump) V   1 2 3 4 > »    
 
  
Reply to this topic

CUV, CLINUVEL PHARMACEUTICALS LIMITED
Billy Boots
post Posted: Today, 02:33 PM
  Quote Post


Posts: 117
Thanks: 77


In Reply To: ignoramus's post @ Today, 01:18 PM

WHY DO WE TOLERATE THIS CHARACTER......HE IS TROUBLE!

 
macgyver
post Posted: Today, 02:24 PM
  Quote Post


Posts: 315
Thanks: 197


In Reply To: ignoramus's post @ Today, 01:18 PM

I think the only thing that will be destroyed will be the pill’s efficacy travelling through the stomach as opposed to the systemic slow release Scenesse implant. Interesting how it hasn’t been done before.... I wouldn’t have thought adding baking soda to melanotan would be an efficient way of releasing afamelanotide to the system....

 
ignoramus
post Posted: Today, 01:18 PM
  Quote Post


Posts: 1,474
Thanks: 546


Macgyver, why have you not mentioned MT-7117? Mitsubishi Tanabe intends to do a multicentre, randomised, double-blind, placebo-controlled study in subjects with EPP. If this trial is successful it will totally destroy Scenesse. No requirement for treatment centres and patients could travel at any time of the year, anywhere. Try getting a Scenesse implant in Peru or France.

I had a lot of success with MT2, particularly concerning the facial area. I had to abandon the trial because I got a very painful gout condition in both feet. All ok now. Maybe no connection with the MT2 so will probably re-challenge again if kidney tests are ok.


 
macgyver
post Posted: Today, 12:25 PM
  Quote Post


Posts: 315
Thanks: 197


In Reply To: LevelHeaded2000's post @ Today, 01:02 AM

I wonder if all the alternative treatments that Iggy has put forth (i.e. Cimetidine, MT2, Dr Parnassum’s Snake Oil, powdered tiger balls) has contributed to the percentage rise. You have to allow for a margin of error (1%), other factors such as personal circumstances, availability, laziness (1%) and then taking into account the ever increasing number of patients lending itself to a higher percentage of those not continuing treatment (1%). Using my shoddy mathematic reasoning, everything looks quite good😜

 
Johnny H
post Posted: Today, 12:05 PM
  Quote Post


Posts: 436
Thanks: 518


More volume today means more money in March.

Hashtag ASX 200. That's how hashtags work, right?



--------------------
Clinuvel until my bowels release for the last time.
 
LevelHeaded2000
post Posted: Today, 01:02 AM
  Quote Post


Posts: 275
Thanks: 468


In Reply To: ajshare's post @ Yesterday, 08:27 PM

If people listened to Iggy and the FUD he constantly spews they would have sold back when shares were $1.50. I really do hope that Iggy is a paid poster by some institution hoping and trying to get in because if he is a poor retail investor that has spent years bashing this stock while the price went up and missed out the whole time then it would just be too sad of a story.


Iggy, you may perhaps be the worst investor ever missing out on an obvious opportunity and so far has missed out on a 10x gain while you have been on this forum.



Said 'Thanks' for this post: BIG BLUE NATION  mrdax  
 


FarmaZutical
post Posted: Yesterday, 10:09 PM
  Quote Post


Posts: 490
Thanks: 1937


While we wait for news about all the exciting stuff thats going on, I'm especially looking forward to XP hopefully being announced as the new indication. IMO XP could be much bigger than most may think. Prevalence is very significant in Japan with app. 5000 sufferers from this horrible disease, and once Scenesse is approved by the PMDA for EPP it probably won't take much to obtain regulatory approval for XP or even reimbursed off-label use. In the US, I think XP is a very good candidate for breakthrough designation once EPP is approved and the first XP trial underway. But Japan could be a game changer faster than we expect.





Japanese regulatory system for approval of off-label drug use: evaluation of safety and effectiveness in literature-based applications.
Shimazawa R1, Ikeda M.<h3 style="-ms-zoom: 1;">Author information</h3>1Graduate School of Biomedical Sciences, Nagasaki University, Japan. r-shima@nagasaki-u.ac.jp
Abstract

BACKGROUND:
Although approved elsewhere, many drug indications remain unapproved in Japan. Many of these unapproved indications are off-label, which, despite strong supporting evidence, are not covered by the Japanese health insurance system. To address this situation, the Ministry of Health, Labour and Welfare of Japan announced in 1999 that, under certain conditions, it would approve a new supplement for a drug indication without clinical trials. This approval scheme involved application evaluation using literature-based evidence; however, the type of indications and the kind of evidence used in practical applications remain to be clarified.


OBJECTIVE:
This commentary sought to investigate the factors that contribute to the approval of individual applications through an analysis of review reports and to assess the outcome of efforts to facilitate the approval of off-label drugs by this approval system that has been used for over a decade in Japan.


METHODS:
Data from 80 approvals granted under this scheme were obtained from the official review reports of the Japanese regulatory agency. The following criteria were selected for the analysis of individual applications: review time, therapeutic class, application category under Japanese regulations, international approval status, postapproval monitoring plan, and variety and quantity of literature evidence. The literature used as a source of evidence was categorized into 4 types: (I) standard textbooks, (II) standard guidelines, (III) reviews, and (IV) application dossier submitted to the foreign regulatory authorities.


RESULTS:
The number of approvals and applications per year showed no consistent trend. The median (SD) review time was 16.4 (9.0) months, which was not affected by the international approval status or the literature evidence. This approval scheme was applied to not only a new indication (56 applications [70%]) or dosage (9 [11%]) but also a new route of administration (13 [16%]). Of the 80 applications, 46 (58%) had been approved in the United States, the United Kingdom, or both; 11 (14%), in other countries; and 23 (29%), in no country. For 2 approvals, the review reports were not released; the other 78 were based on either standard textbooks or guidelines, while 67 (84%) were based on both. The variety and quantity of literature evidence provided in the application showed no consistent trend with respect to international approval status.


CONCLUSIONS:
Prior approval by foreign authorities, although important, did not appear to be essential for approval in Japan. However, substantiating safety and effectiveness of agents by means of standard textbooks or guidelines was used consistently to obtain approval for off-label use.







Said 'Thanks' for this post: PunkassDerm  blackm3  willo76  Farleap11  Verharven  Frogster  johnnytech  xray  juxtaposer  
 
ajshare
post Posted: Yesterday, 08:27 PM
  Quote Post


Posts: 289
Thanks: 692


In Reply To: seeva222's post @ Yesterday, 09:56 AM

Every time iggy spray's the sh*t the shares go up. I always buy big when he is in full force...thanks iggy for your indicators.


Said 'Thanks' for this post: Verharven  
 
PunkassDerm
post Posted: Yesterday, 01:32 PM
  Quote Post


Posts: 405
Thanks: 1116


In Reply To: Dr Wally's post @ Yesterday, 01:20 PM

Maybe transition to cosmetics / regenerative medicine. Stem cells and MSH.

Cure HPV (warts), non-melanoma skin cancer and acne....we would be twiddling thumbs in derm.


Said 'Thanks' for this post: Dr Wally  
 
Dr Wally
post Posted: Yesterday, 01:20 PM
  Quote Post


Posts: 293
Thanks: 329


In Reply To: PunkassDerm's post @ Yesterday, 12:38 PM

Seemingly a few years off yet but proof of concept has been well and truely confirmed it seems. I bet they won’t get the extended regulatory F around like Clinuvel has had to go through. Good for them. So many exiting breakthroughs going on everywhere atm.

Are you kidding! 🤓 $200-300/share is only a few years off also.

The world is going to be shocked big time when they realise that the fabled natural, cancer preventative, photo protective, therapeutic and completely safe tan that they’ve heard whispers about for 3 decades now has become reality. Exiting times indeed.

It feels good to have a stake in a wholesome company like Clinuvel. Their completely safe drug is destined to alleviate serve pain and give a full life to thousands of vulnerable people with no other options and one day provide the ultimate in photo protection to multiple millions and preventing skin cancer like nothing that has come before.

This drug might even put you out of business. Lucky you’ve covered your ass with a sh1t load of Clinuvel. 🤓

I don’t feel that it’s a bad thing or detrimental to anyone’s cause to be talking like this in 2019 simply because if the FDA is coming here for information then the world really is f@cked. Completely F@cked!! 😑
These guys have been struggling with and contemplating the realities of approving this drug for a good decade at least but they’ve realised probably a few years ago now that tanned skin isn’t the work of the devil and that the benefits of this long awaited game changing drug completely outweigh any negatives. Is there even 1 negative to this drug??

Only thing I can think of is the possibility, because the drug is so photo protective, that low D levels could be an issue?



--------------------

Any price pre FDA approval will be seen as an absolute bargain within 2-3 years. 🙂

Said 'Thanks' for this post: PunkassDerm  FarmaZutical  
 
 


4281 Pages (Click to Jump) V   1 2 3 4 > » 

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