Anavex Life Sciences Corp (AVXL)

[dennisdave]

So more data saying the same thing will somehow magically convince the EMA review team?
The EMA’s negative trend vote already means the core efficacy package was judged insufficient, even after Anavex presented all their best arguments during the oral explanation. Re-examination isn’t a chance to submit a new, stronger dossier it only allows re-arguing the same data that regulators already found unconvincing.

All those ADNI comparisons, ABCLEAR analyses, and post-hoc subgroups suffer from the same fatal flaw: they are exploratory, biased, and not acceptable as proof of efficacy in Alzheimer’s. A new reviewer team won’t magically reinterpret weak, post-hoc evidence as strong, pre-specified clinical results that’s not how regulators work.

Re-examination almost never overturns a clearly negative CHMP opinion, especially when the pivotal trial failed to deliver robust, primary-endpoint evidence.

Its over. The sooner everyone accepts that the better