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georgejjl

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georgejjl

Re: 12x post# 423058

Sunday, 07/16/2023 4:06:32 PM

Sunday, July 16, 2023 4:06:32 PM

Post# of 463840
NO, actually no additional phase 3 is required to approve Anavex's blarcamesine for the treatment of Alzheimer's disease.

Considering the results from the Phase 2b/3 trial and given the efficacy results of surrogate biomarkers from the ANAVEX®2-73-AD-004 study; allowing initiation of discussions with regulatory agencies for Accelerated Approval Pathway for ANAVEX®2-73 (blarcamesine) in Alzheimer’s disease with convenient oral treatment.

A phase 4 trial is being planned to run concurrently with commercial sales as the result of accelerated approval.

https://www.anavex.com/post/anavex-life-sciences-reports-fiscal-2023-second-quarter-financial-results

GOD bless,
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