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Doc328

11/14/25 8:59 AM

#507896 RE: Gernee20 #507883

They did meet according to some CC's from 2023. Most likely they said you need another trial flat out - biomarker data with high dropout is insufficient for accelerated approval --- don't waste our time and yours. And then, LOL, the EMA begged Missling to submit and the rest is history...
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boi568

11/14/25 8:59 AM

#507897 RE: Gernee20 #507883

I think it's clear that Anavex was not expecting this. The FDA meeting was going to boost the good news from the EMA.

I am not selling. Aside from the against the odds possibility of a successful EMA re-examination and/or a success with the FDA, I am convinced that this drug, by pre specifying the ABCLEAR3 group in a new trial, will easily succeed in a new trial. It may be by Anavex or it may be by a company that has acquired Anavex.

Unless we see an unexpected regulatory success, I think Anavex will need to sell out or partner in the near future. Stockholders will still make money here. Just not nearly as much.