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skitahoe

03/23/24 5:35 PM

#454832 RE: Jonjones325 #454829

I'm certainly no expert, but if you go for Complete MA, isn't it still very possible that the regulators will approve with conditions anyway. The only way I would think you'd go for Conditional is if going in the only way you think you can gain approval is by offering conditions you'll meet on the regulator granting such approval. I.E. if you know you have to run additional trials, concede it up front.

In the case of many products, new trials will be needed post approval for label expansion. I see no reason not to say that if it's already acknowledged to be the case.

Gary
Bullish
Bullish
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Steady_T

03/24/24 12:41 AM

#454849 RE: Jonjones325 #454829

From the PR.
If Missling used the word complete in one of the CC calls, I missed it.

Pursuant to the discussion at the meetings, Anavex initiated the process for submitting a Marketing Authorisation application to the EMA with the submission of the Centralised Procedure request with the goal of the Authorisation allowing direct access to the market of the European Union for oral blarcamesine for the treatment of Alzheimer’s disease.

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Investor2014

03/24/24 3:46 AM

#454854 RE: Jonjones325 #454829

Yes Complete non conditional approval. Do have the reference to hand.