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post Posted: Jul 29 2018, 11:01 PM
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Can we open a petition to stop PW from writing any more newsletters? It's just a nonsense investment of time if all you intend to do is confuse.

Either be clear, concise and reliable or invest your time somewhere else, eg in getting core business running

Said 'Thanks' for this post: macgyver  Mauricinho  
post Posted: Jul 29 2018, 10:55 PM
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In Reply To: Dr Wally's post @ Jul 28 2018, 10:27 PM

2020 would be a bad joke.

but as we see here, like always, after PWs newsletter there is more confusion than ever before.

Said 'Thanks' for this post: mrdax  
post Posted: Jul 29 2018, 06:27 PM
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In Reply To: investek's post @ Jul 29 2018, 05:01 PM

Good summary.
But if it's asking too much to do a two-month forecast at the start of April about three articles, which imho, completely lays in their hands (just need to write them?), I'm asking: how should they forecast a full year or even further ahead?

They missed June and more probably Juli. So out of a two-month timeframe they made more than four months.

What will they do out of half a year (time until end of 2018)?

Guess is, end of autumn they'll say they'll release the products after FDA approval. Hence it's gonna be in 2020.


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post Posted: Jul 29 2018, 05:01 PM
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In April and May, CLINUVEL will publish three successive SCIENTIFIC COMMUNIQUÉS to review the current understanding and progress in proopiomelanocortin (POMC) science and photomedicine.

9th April 2018É1.pdf

In SCIENTIFIC COMMUNIQUÉ III –scheduled for June – we will review the effects of afamelanotide, CLINUVEL’s lead drug, on the human genome, based on existing literature.

May 2018É_II_FULL.pdf

Well they’ve missed June (2018), not many days left if SCIENTIFIC COMMUNIQUÉ III is to be published in July...

CLINUVEL will attract a wider audience in 2018, not the least by diversifying its product offerings to new markets. The knowledge gained as a specialty pharmaceutical company, and the confidence gained among the top academic experts worldwide, will need to be translated into a continuum benefiting a wider market. CLINUVEL will launch its premiere non-pharmaceutical product lines under private label. These dermatological products will be complementary to SCENESSE®. Fitting our 2018 strategy, CLINUVEL will exhibit its first conference display in Asia and Europe, our main targeted markets. This will be discussed by our Managing Director in more detail over coming months.

11th Jan 2018

1) Will we see an actual launch of these dermatological products this year? (Will it actually be possible to buy something from CUV or Vallaurix as a consumer??!)

2) Will Clinuvel exhibit at conferences in Asia and Europe within 2018? (Aside from a vitiligo conference we haven’t found much evidence)

3) Will we (at a minimum) be able to see and touch non-pharmaceutical products at this year’s AGM?

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post Posted: Jul 29 2018, 02:13 AM
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The reason it's not a topical is molecule size and potency. CUV9900 and the University of Cincinnati researchers' ones are smaller and more potent. If a topical Scenesse worked, it would almost certainly be due to systemic effects unless there is some new formulation that allows better penetration. Some companies do research this stuff for other purposes.

I'm guessing the cosmetic approval thing is just some generic paperwork that needs to be submitted to make sure you can legally market/sell a product. In the FDA there are various levels of "clearance" like this for devices and I think for regular products too. I'd hope that management didn't expect something to require the full trial route, but it actually does. Any topical Afamelanotide or CUV9900 would need trials in the USA (not sure about Asia and other marketes), perhaps if it's Afamelanotide it would be quicker though.

I'm really hoping that the 24 month approval window is just a worst case scenario in the event that the FDA requires more data from the Europe post-approval monitoring. As mentioned in the newsletter which confirmed what I thought, Scenesse has been proven safe in patients for a way longer period of time than most orphan drugs. Usually it's 1-2 years in a phase 3 trial and that's it. Scenesse has been used for something around 10 years by some people with no significant adverse effects.

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post Posted: Jul 28 2018, 10:43 PM
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In Reply To: ignoramus's post @ Jul 28 2018, 12:24 PM

Secondly, IIRC the molecules size was said to be too big to penetrate the skin.

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post Posted: Jul 28 2018, 10:27 PM
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In Reply To: NewToCli's post @ Jul 28 2018, 02:08 AM

“and why is he mentioning fda can take up to 24 months?”

From what I understand of this standard or priority review program BS the 6 month or ten month timeframe is “a goal”, the absolute best case scenario for nice little non controversial drugs that tick all the boxes but for ground breaking, game changing, massively controversial drugs like Scenesse (that safely tan the skin and prevent skin cancer, flying in the face of their 5 decade old rhetoric) that 6 month timeframe can simply blow out for whatever reason they feel warrants it.
“Clinuvel 2020” is the cryptic clue that says to me that this is the year Clinuvel expects to gain FDA approval for Scenesse.

Wishing everyone the best of luck through these testing times. Hopefully we’ll all be getting back on track towards the end of this incredible year 2020.

Understand the reality of this unprecedented situation but don’t panic.

2020. Year of the germ!

Said 'Thanks' for this post: mrdax  
post Posted: Jul 28 2018, 08:03 PM
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In Reply To: Frogster's post @ Jul 26 2018, 01:52 PM

I think, we won't see an APPENDIX 4C ever again! I've tracked this for the australian company "Nanosonics" (ASX: NAN). After the fourth consecutive CF positive statement on 16/01/2017, they've never issued it again.

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post Posted: Jul 28 2018, 12:24 PM
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In Reply To: Crembo's post @ Jul 28 2018, 09:18 AM

I thought somebody had said long ago that afamelanotide had a short half-life (whatever that means) so it would not be suitable for a pill or a topical cosmetic cream. First I’ve ever heard that the reason for an implant was to prevent off-label use and uncontrollable dosage forms. How would this restriction work with a cosmetic containing afamelanotide?

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post Posted: Jul 28 2018, 09:18 AM
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In Reply To: macgyver's post @ Jul 28 2018, 05:30 AM



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