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post Posted: Yesterday, 11:16 AM
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In Reply To: Clinhope's post @ Yesterday, 09:06 AM

Uho was on this board a very long time ago.

post Posted: Yesterday, 10:06 AM
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In Reply To: Farleap11's post @ Feb 17 2020, 10:09 PM

I incorrectly posted something a while back relating to Clinuvel’s requirement to report safety data to the EMA, of which I assumed incorrectly that Clinuvel was no longer obligated to do. As it was it was just the EMA renewing the authorisation under exceptional circumstances. During my research I came across a couple of drugs that have had constant monitoring for a lengthy period of i.e. ten years or more. I guess the reason for that was to gauge safety of the drug over long term (new molecules?). I would not be surprised if afamelanotide remains under a lengthy monitoring regime as well. I think that’s fine, it’s not a crutch for the company, it’s exactly the opposite with long term data collected of value to Clinuvel.

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post Posted: Yesterday, 09:06 AM
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In Reply To: sharelooker's post @ Yesterday, 02:41 AM

Not a chance, this is a person that could do some seriously impressive research on a company essentially no one cares about and was happy to do so week in week out for YEARS with minimal interaction from other Clinuvel investors. A seemingly thankless endeavour.

As far as i can tell he never showed up here and after the way the last few months played out i don't think he ever will.

Member of the “ALL-IN” club 2018.
post Posted: Yesterday, 05:38 AM
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In Reply To: sharelooker's post @ Yesterday, 02:41 AM

Very similar situation, indeed. Thanks for sharing.

It confirms my hunch that the suggested Phase 2b for
Vitiligo is indeed a pivotal Phase 2b/3 if the FDA agrees.

In that case, it’s not unrealistic that Scenesse could be approved
for Vitiligo within 3 years. And if the other shorter trials pan out
perhaps we could even see XP and VP approved before then.

News about the FDA signing off on a pivotal Phase 2b/3 for
any indication beyond EPP would be of tremendous value IMO.

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post Posted: Yesterday, 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.

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post Posted: Yesterday, 02:41 AM
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In Reply To: Kalaz's post @ Yesterday, 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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post Posted: Yesterday, 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..

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".


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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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

“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.

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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