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boi568

05/10/24 2:45 AM

#458744 RE: Anshu2 #458742

The AD trial succeeded against the FDA draft guidance criteria through its ADAS-Cog result. (It succeeded under the .025 methodology, as well.) So long as the Agency's draft guidance is finalized before a decision is rendered on any Anavex AD NDA, or so long as the draft guidance is informally governing FDA practice now and remains unchanged, Anavex's 2b/3 AD trial succeeded by the only way clinical trials are scored.

Success or failure is graded according to FDA standards, not prior practice or discarded or otherwise inapplicable rules. And certainly not by the opinions of message board posters.