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You're right! I don't understand the contradictory information (that the Transparency Committee can't decide on the SMR and the ASMR during the contradictory phase). The truth is that the TC can change its decision during the phase contradictoire.


In order to understand exactly how the contradictory phase works, I found a record of a meeting that took place on March 18, 2020, in which the various hearings held are transcribed.


Meeting March 18



Based on what I read, I came to the following conclusions:


  • the TC came to a decision regarding Scenesse;
  • Clinuvel did not accept the TC decision and asked to be heard;
  • the TC can maintain its initial decision or change that decision after hearing Clinuvel's arguments.

However, different scenarios are possible. The hearing does not necessarily imply that Scenesse was rejected. It may happen that it has even been unanimously approved, but that the level of ASMR is not what is desired by Clinuvel and that the hearing is aimed precisely at changing that level.



There are two kinds of vote for the approval of a drug in France: the SMR vote and the ASMR vote.



The SMR vote is, in essence, the approval or rejection of the drug. If the SMR is considered positive by the majority of voters, the drug is approved.


The ASMR vote will have a direct impact on the amount the French state will reimburse. The ASMR has 5 levels: the higher the level, the lower the refund amount. If Scenesse is voted as ASMR V, possibly the French state will refund only 10% to 20% of the total price; if it is voted as ASMR I, the French state is likely to refund between 90% to 100% of the total price.



Therefore, it is perfectly possible that Scenesse has been approved, but that Clinuvel is not happy with the level of the ASMR that the TC assigned. A hearing is not necessarily associated with the rejection of a drug.



At the March 18 meeting, the pharmaceutical companies BLUEBIRDBIO (p.6) and TAKEDA FRANCE (p.15) requested the change in the ASMR level. The drugs were approved, but they were not satisfied with the assigned ASMR level.



Personally, and taking into account all the information available regarding the effectiveness of Scenesse, I believe that our peptide was approved by the TC and that Clinuvel requested this hearing to try to raise the level of ASMR.



I hope I helped to clarify this process and I apologize to everyone if I created false expectations with my previous post.

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Hey Billy


I also don't agree with everything regarding our management, but the glass is still half full in my view.

If I were in your emotional world, I would be constantly in a bad mood, terribly annoying for everyone around me and it would be bad for my health anyway.

That wouldn't be worth!

If I could't love or change it, for sure I would leave it ... At least I would sell a big parcel of my shares!

No offence, just my humble oppinion

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One more order added to the list (a pretty big one):



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My thoughts, directed at no one in particular, and backed up by no evidence whatsoever:


The shorts are in some serious trouble. There were some very legitimate reasons to short in 2019. It looked like the US rollout was going to follow the pattern of the EU rollout, especially with the radio silence after approval, and then the statements suggesting treatments beginning "sometime" by the end of 2020.


The rollout wasn't as fast as I would have hoped, but it was certainly faster than most evidence-based investors would have expected.


The upwards trend in share price is obvious, and it cannot be contained. It seems that as soon as there is some upwards pressure on the share price, a few new shorts open to push the price back down. That doesn't work when there are over 4 million open short positions to be closed.


The shorters are now in competition with each other.... who is going to keep playing games, and who is going to get out clean? I'd be jumping ship right about now....


I bought 5000 shares today. I might do it again tomorrow. And the next day.


The brokers who shorted when the price was below 17 bucks? You're going to get fired.

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I don't think they'd be able to fully exit until FDA approval prices. We're talking shorts that are almost 10% of issue, which is probably almost 20% of float.



1st shorter out might be made whole; the rest are (insert profanity here)

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