I find it mindboggling that people downplay an AD P2b/3 trial that met all endpoints, where patients functionally improved and somehow think another proving trial is needed.
FUDsters trying to make issue of the odds ratios and now doing the same with titration, are nothing more than FUD attempts to discourage investment. It's their job.
Though it seems the company is prioritizing Rett ahead of AD, for voucher purposes, I have no doubt that blarcamesine will be approved for AD on the strength of the trial's results. Whether it be traditional approval or accelerated, w/surrogate biomarker, will depend upon FDA guidance. The confirmatory trial will most likely be designated a P4 at the time of approval.
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