Good post that basically captures my train of thought also. A key paragraph:
"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."
I would make one change to the above that captures my thinking exactly. I would replace "It doesn't matter" with "It may not matter". The whole approval decision may hinge on the regulators accepting Blarcamisine's minor flaws with respect to the major flaws of the Mab's.
IMO, the FDA's acceptance of the Mabs was an inflection point. After 30+ years of R&D failure of Big Pharma, the FDA caved and IMO signaled that new rules must be adopted. Main street is playing by the old rules and as such AVXL stock is punished. Main street and the regulators opinions are about to diverge, IMO.
The JPAD authors did not say that Blarcamisine was perfect, but that it can be a favorable alternative to the Mabs. The unnamed scientific "peers" agreed and the paper was published. Given that, I think the unnamed EMA regulators may also agree, and therefore approve. Faith vs fact? Judge for yourselves.
It is not that Investor and Doc are wrong with the facts as we know them. But, "it may not matter."
IMHO
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