Investor and Doc328 seem to want Anavex and its shareholders to be punished for not following the trial format and post-trial time lines they have in their minds as the only way things are done.
Most people get now that the outcome here depends on what Anavex has submitted to the EMA and not the wandering history of how the MAA final results came to be.
It doesn't matter that the company used and then abandoned an Odds Ratio analysis; it doesn't matter that the 24 hour turnaround right before 2022 CTAD resulted in a bit of data correction; it doesn't matter to the EMA that the MMRM analysis came late, or it took Anavex a long time to get the MAA together; it doesn't matter to the EMA that the whole process may offend the sensibilities of management consultants, or business executives, or competitors.
There are a number of unprecedented strengths in the application, and no apparent fatal flaws. (If fatal flaws were apparent, the EMA would have refused to permit the MAA waste its time in the first place. Eighty three percent tells you this.) So all this fuss about single trial, low n, and the missed irrelevant ADL endpoint seems more like a continuing sandbox tantrum than a serious argument. It has certainly reached the point where egos are entangled into these objections.
Agencies tell you what they care about and, from that point of view, Anavex looks to be in good shape for an approval. It's in the hands of the EMA now. See this from their point of view, not the point of view that's been overtaken, and contradicted, by events.
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