A counterpoint again: research guidelines are merely guidelines. We disagree but I think it is important for people reading these exchanges to know that some people (like me) don't believe that FDA consideration of blarcasermine will be even a little impacted by ADL slight miss due to prodromal population.
The problem that Anavex has anticipated is failing to run a confirmatory trial. Doubtless they are hoping that the recent flurry of papers and the pending CHMP decision will sway the FDA to disregard that issue.
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