Blarcamesine did NOT statistically fail one of the co-primary endpoints of the Phase 2b/3 Alzheimer's trial. I challenge you to show in writing the Phase 2b/3 statistically failed co-primary.
Regarding the dose response. The 50 mg per day dose is stronger in most participants than the 30 mg per day dose,
Quit making up FACTS. FACTS are FACTS. Quit making up the FACTS.
Why there is so much conversation about AD at this point in time surprises me. Rett will be filed before AD and Rett approval will make Anavex a revenue producing company. That is the most important next step.
You assume that one of the co-primary endpoints has failed. Whether that is in fact the case is not yet known. What we do know is the company likes the single endpoint and strong P values of the secondary endpoints approach. The exact reasons the company is making that choice is not known. It may present a stronger over all case than the co-primary endpoints will. We don't know.
I agree that the FDA is concerned with the data that is presented and little else.
I don't agree with your evaluation of the dose response data. At worst it demonstrates a ceiling effect as long as the efficacy is demonstrated at the 30 and 50 mg doses. Sub group analysis may show that the wild type SR1 subjects ceiling out at 30 to 40 mg dose and the mutant type require the higher dose closer to 50mg. We shall see when the paper comes out.
The company has shown little interest in PRs about FDA meetings in the past so I don't see that changing now.
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