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CUV - CLINUVEL PHARMACEUTICALS LIMITED


colaiscute

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You forgot my favourite bit:

 

Concomitant afamelanotide administration can reduce the NB-UVB dose and potential adverse effects. Possible use of afamelanotide as monotherapy in vitiligo treatment may be evaluated in future studies.
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Three items I'd like to see discussed in this week's newsletter:

 

1. What are the plans for the China rollout? It was a pleasant surprise to hear the company was entering that market however, it was not clear on several fronts. Are the 10 patients being treated considered an actual "trial"; if so, how long would this trial last before Scenesse is fully available? If a trial is not required access to the 5,000 estimated patients in China be a huge revenue boost in the next few years.

 

2. Next steps with the FDA before CUV 104 and 105 trials can commence for vitiligo. Will these 2 trials run concurrently or in succession? This determines whether FDA approval might happen in 2 years or 5 years.

 

3. Comments on the US rollout. All we know for sure is Dr. Resnick has administered Scenesse to 2 patients. With 4 centers now open what kind of impact on 4th quarter revenue might we expect? Keep in mind that through the first 3 quarters of this fiscal year FY20 total revenue is actually $326k less than FY19. Treating 50 or 60 patients in the US this quarter could have an immediate impact of $1M+ this quarter.

 

FY19 total revenue was $32.2M and its likely FY20 revenue won't be significantly higher. However, there is good reason to believe that FY21 revenue could really take off.

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All very relevant points which would be great to see clarity on.

 

I'd particularly like to see clarity on the vitiligo path. The March PR in which they published the date of the Type C meeting suggested it would be to discuss CUV104 and CUV105. The early May post Type C meeting PR mentioned amending the protocol for CUV104 and the step of making a sNDA, but had no mention whatsoever of CUV105. I'm hoping that means there won't be an issue of running trials sequentially or concurrently, but rather, subject to satisfactory results, that only one further trial is required.

 

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That was my reading of it too Frogster that potentially only one P3 was needed with PW planning for two initially to be conservative as he did use the language of '1 or 2' at the AGM from memory when questioned around this indication.
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I think we may have gotten our hint in the Clinhope/Seeva222 post below.

 

One trial with Scenesse+UVB, and one trial with Scenesse only. As a pooled study, the results are stronger than either trial alone. Scenesse+UVB has placebo/control issues; the controls know they're not getting an implant. Scenesse only has the unblinding and dropout issues; the patients know if they're the control, and when they are, they drop out because they don't want to have a mild surgical procedure for nothing.

 

Best case scenario is that Scenesse only works, as removing the UVB portion eliminates the biggest safety issue: a phototherapy that's known to be carcinogenic. That tips the risk/benefit strongly in favor, and makes sNDA approval a slam dunk. If S+UVB works slightly better, that's a decision between patients and their doctor.

 

My biggest hope here is that Clinuvel was listening very carefully when the FDA told them what to do.

 

 

 

 

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I could be wrong on this, but I would see it as 'unusual' to do two separately named trials when it could all be done under a single umbrella as a Scenesse only treatment just becomes another arm of the same trial. Once you divide them into two separate trials, you are dealing with potentially different overall protocols, duplication of registration and ethics, and a small question of the statistics validity when making direct comparisons between groups as you would not be randomising against the same pool of patients who were recruited under a single protocol.
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Keep the faith Señor Boots, after all thatâ€â„¢s why youâ€â„¢re still here eh?
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cuv has to come up with ever better revenues to overcome the eu scenesse sales stall and winter dip in sales.

If they can increase sales from the usa and roll out the cosmetic line that would help a lot.

I'm not counting on uk or France. Vitiligo is still a pie in the sky until we get further news. China is a question mark if we will move fast or not.

DNA repair trial has gone quiet again.

 

Every quarterly we should be surprised by yet another increase for 2 years in a row just on epp and cosmetics.

glta

 

 

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