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CUV, CLINUVEL PHARMACEUTICALS LIMITED
sharelooker
post Posted: Feb 18 2020, 03:25 AM
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CRPX is in a similar situation like CUV. They got approval for firdapsa for the treatment of LEMS and now trying to get it through the sNDA gateway with a phase 2/3 trial (60 patients) in Anti-MuSK antibody positive myasthenia gravis.

https://ir.catalystpharma.com/news-releases...mated-firdapser


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sharelooker
post Posted: Feb 18 2020, 02:41 AM
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In Reply To: Kalaz's post @ Feb 18 2020, 01:46 AM

Uho left google groups because one of his posts was deleted (by google?). So, i assume he is angry about it and sulks.

@Uho:Please join our community on sharecafe. Your knowledge is in great demand here!


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Kalaz
post Posted: Feb 18 2020, 01:46 AM
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Somehow I lost my thank button, but I have it back now.. some good posts lately.. not seeing anything from uho over at GG in awhile..

 
Farleap11
post Posted: Feb 17 2020, 10:09 PM
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Out of curiosity and without any expectations re an outcome, I visited the NICE web site to see whether I might stumble upon anything of interest regarding next steps re the outcomes from CUV's successful appeal.
I ended up heading in a different direction in that I was transferred to the EMA's site when I clicked on a link for SCENESSE dealing with, "Procedural steps taken and scientific information after authorisation".

ttps://www.ema.europa.eu/en/documents/procedural-steps-after/scenesse-epar-procedural-steps-taken-scientific-information-after-authorisation_en.pdf

Much of the recent material deals with changes to the manufacturing sites for Scenesse. However, the document also shows that re-assessments are carried out on the 26 April each year - the last one on 26 April 2019 was the 4th annual re-assessment. Entries in the comments column have so far been the same each year and read as follows:

"The CHMP having reviewed the evidence of compliance with specific obligations and the impact of the data submitted by the MAH on the benefit/risk profile of the medicinal product, concluded that the marketing authorisation under exceptional circumstances of Scenesse should be maintained."

I suspect this question may well have been raised before; however, I am seeking advice from any of the more learned contributors who may be able to tell me whether there is a set number of years that these controls remain in place or is left to the discretion of the CHMP based upon the overall effectiveness / safety record of the product concerned?

By the way I was unable to locate any reference(s) to what action NICE might be considering in response to CUV's successful appeal against their decision to not support Scenesse from a financial perspective - not that I really expected to.



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macgyver
post Posted: Feb 17 2020, 07:43 PM
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In Reply To: Dr Wally's post @ Feb 17 2020, 06:25 PM

QUOTE
“a disaster waiting to happen” could likely cause unnecessary safety concerns for the others Scenesse in particular for absolutely no reason whatsoever so its fkng stupid gibberish, and for what reason?


I have to laugh when I look at this sentence. Its very dramatic.

 
macgyver
post Posted: Feb 17 2020, 07:28 PM
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In Reply To: Dr Wally's post @ Feb 17 2020, 05:36 PM

The problem is not the drug, its the marketing and application that's the problem. Capped off with a dumb name to boot. The disaster in question is that Vylessi will have low sales, and I think Spana is misreading the landscape regarding what women want and that perhaps there's more to it than taking a drug?

They're not commercialising it very well IMHO. Surely there must be some other indication they could've gone after with a more robust efficacy score and/or orphan status perhaps? Seems to me they just wanted to get it out there, or rather Carl Spana is no PW and didn't know what the hell to do with it. Perhaps he just wants it go off label pronto...

 

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Dr Wally
post Posted: Feb 17 2020, 06:25 PM
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In Reply To: waz's post @ Feb 17 2020, 05:56 PM

“”Nope. Different peptide. Brem is not even MT2. It is a derivative.””


Yep! That’s what I said.

“” (extremely similar to Afamelanotide/MT2)””


“”Bremelanotide is an active metabolite of melanotan II that lacks the C-terminal amidegroup.[17]

Aside from melanotan II and endogenous melanocyte-stimulating hormones like α-MSH, other peptide analogues of the same family as bremelanotide include afamelanotide (NDP-α-MSH), modimelanotide, and setmelanotide.””

All of these peptides are incredibly similar so calling one out as being suspected of being “a disaster waiting to happen” could likely cause unnecessary safety concerns for the others Scenesse in particular for absolutely no reason whatsoever so its fkng stupid gibberish, and for what reason?



--------------------
“” The discovery of the endogenous melanocortin agonists in the 1950s have resulted in sixty years of melanocortin ligand research.””

The never ending quest to have Afamelanotide (peptide) (SEMI) accepted for its potent ability to stimulate a natural photoprotective,cancer preventative, therapeutic “tan” was (SEMI) accomplished in 2019.

Regulator ignorance, bias, and stubborn resistance to Scenesse are the primary reasons behind this glacial journey. The evidence should be clear to all by now.
 
waz
post Posted: Feb 17 2020, 05:56 PM
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"Will the disaster your calling out concerning Brem have implications for Scenesse??"

Nope. Different peptide. Brem is not even MT2. It is a derivative.

FWIW, MT2 was handed back to Competitive Technologies by Palatin as part of a legal agreement which resulted in Palatin paying US$800k to Competitive Technologies over their Brem derivative.

In response to macgyver, would be interesting to understand current status of MT2. Probably close to being out of patent and CUV would do well, perhaps, by taking it over if still available.


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Dr Wally
post Posted: Feb 17 2020, 05:36 PM
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In Reply To: macgyver's post @ Feb 17 2020, 08:23 AM

“”I’m calling it now, Vyleesi is a disaster waiting to happen, and while it’s trying to address an important issue it’s the wrong drug to do it with.””


Really? On what possible evidence are you claiming Bremelanotide (extremely similar to Afamelanotide/MT2) is a disaster of some kind?? Just waiting to happen??


Will the disaster your calling out concerning Brem have implications for Scenesse??


I know theres not much happening right now (that we know about ) but do we really need any more hysteria concerning these now FDA approved safe drugs?


You should know better Mac seeings you’ve been privy to a tonne of inside information here over many years


it’s the wrong drug to do it with.”” ???


Where do you get this baseless BS from Mac Daddy?

666 devilsmiley.gif



--------------------
“” The discovery of the endogenous melanocortin agonists in the 1950s have resulted in sixty years of melanocortin ligand research.””

The never ending quest to have Afamelanotide (peptide) (SEMI) accepted for its potent ability to stimulate a natural photoprotective,cancer preventative, therapeutic “tan” was (SEMI) accomplished in 2019.

Regulator ignorance, bias, and stubborn resistance to Scenesse are the primary reasons behind this glacial journey. The evidence should be clear to all by now.
 
waz
post Posted: Feb 17 2020, 04:32 PM
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Shorter re-loading the ammo, trying to borrow more stock..

 
 


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