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 >

4318 Pages (Click to Jump) V  « < 35 36 37 38 39 40 41 > »    
 
  
Reply to this topic

CUV, CLINUVEL PHARMACEUTICALS LIMITED
FarmaZutical
post Posted: Jan 20 2019, 10:09 PM
  Quote Post


Posts: 497
Thanks: 1959


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  Dr Wally  
 
ajshare
post Posted: Jan 20 2019, 08:27 PM
  Quote Post


Posts: 292
Thanks: 700


In Reply To: seeva222's post @ Jan 20 2019, 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: Jan 20 2019, 01:32 PM
  Quote Post


Posts: 418
Thanks: 1149


In Reply To: Dr Wally's post @ Jan 20 2019, 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: Jan 20 2019, 01:20 PM
  Quote Post


Posts: 295
Thanks: 330


In Reply To: PunkassDerm's post @ Jan 20 2019, 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?



--------------------
NO! There IS such a thing as a safe tan. “Black” people have known this for a while now. 🙂

Said 'Thanks' for this post: PunkassDerm  FarmaZutical  
 
PunkassDerm
post Posted: Jan 20 2019, 12:38 PM
  Quote Post


Posts: 418
Thanks: 1149


In Reply To: Dr Wally's post @ Jan 20 2019, 12:22 PM

Still in infancy, how many GI absorption peptides are currently on market? How far off?

I'm still waiting for my safe tan anti-inflammatory drug.

Totally ready to retire at 200/share. But I'll take 300.

 
Dr Wally
post Posted: Jan 20 2019, 12:22 PM
  Quote Post


Posts: 295
Thanks: 330


In Reply To: PunkassDerm's post @ Jan 20 2019, 05:42 AM

“”Was going to say same thing. Like insulin, a peptide cannot be delivered PO (per os) or by oral route. “”

Individuals with type 1 diabetes must inject themselves with the required dose of insulin daily to manage their condition. In the future, injections may no longer be necessary; scientists are developing a viable way of delivering insulin in pill form.

https://www.medicalnewstoday.com/articles/322258.php

“”1. Peptides are fragile, need to be injectable or transdermal,””

“PO peptides it appears will be far off and not available for every sequence”


“Peptides, short amino acid chains that control many functions in the human body, represent a billion-dollar market, also in the pharmaceutical industry. But, normally these medications must be injected. A research team led by the Technical University of Munich (TUM) has now determined how peptides can be designed so that they can be easily administered as a liquid or tablet.”

https://www.sciencedaily.com/releases/2018/...80221122406.htm

Keeping up with the latest scientific breakthroughs in these times of fundamental change must be difficult when your busy working long hours and managing a monstrous holding of Clinuvel. 😉

I have faith that the expert team at Clinuvel would be all over these advancements. 😐


“Unless Iggy was personally administering the drug I would not worry.” Buuuuurn IGGY! 😂😂



--------------------
NO! There IS such a thing as a safe tan. “Black” people have known this for a while now. 🙂

Said 'Thanks' for this post: PunkassDerm  
 


Johnny H
post Posted: Jan 20 2019, 12:21 PM
  Quote Post


Posts: 474
Thanks: 577


In Reply To: PunkassDerm's post @ Jan 20 2019, 11:23 AM

It's pretty typical. They're walking a tightrope. They want patent protection to prevent competitors from marketing pro-drug analogs, while, at the same time, preventing the leakage of trade secrets.

Clinuvel does the same thing. (i.e. some of their Vallurix patents). They have a hexapeptide that they've enhanced by adding methyl, ethyl, and propyl groups onto the C terminus of the peptide chain. They never specify which ones are CUV 9900 and VLRX001, but they've patented the entire class of compounds to shut down competitors.



--------------------
Clinuvel until my bowels release for the last time.
 
PunkassDerm
post Posted: Jan 20 2019, 11:23 AM
  Quote Post


Posts: 418
Thanks: 1149


In Reply To: Johnny H's post @ Jan 20 2019, 08:13 AM

Seems purposefully vague. The intention to monopolize an entire class without actually have a drug? Would this sort of patent have any teeth legally? I nothing of drug patents.

Claiming a patent for every variant of a structure.


Said 'Thanks' for this post: Johnny H  
 
ignoramus
post Posted: Jan 20 2019, 10:29 AM
  Quote Post


Posts: 1,491
Thanks: 549


I can see a few here are having trouble with the facts. Never mind. I still believe that Scenesse will get FDA approval. This is assuming that Clinuvel’s newsletters, now 'communique', are basically accurate. No need to panic.

 
Johnny H
post Posted: Jan 20 2019, 10:06 AM
  Quote Post


Posts: 474
Thanks: 577


In Reply To: seeva222's post @ Jan 20 2019, 09:56 AM

"is now at 5%, down from 2%"

Genius.



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


4318 Pages (Click to Jump) V  « < 35 36 37 38 39 40 41 > » 

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