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Re: Jonjones325 post# 368281

Sunday, 07/31/2022 1:56:02 PM

Sunday, July 31, 2022 1:56:02 PM

Post# of 517359
I am trained by experience and education to be critical and sceptical building models of potential outcomes informed by the data available.

We know that P3 trials are required for PDD and PD. We also now know the correlation between the genetic pathways and the cognitive scoring systems between PDD and AD outcome measures.

Yet, "Full genomic analysis of ANAVEX®2-73-PDD-001 Phase 2 study in
patients with Parkinson’s Disease Dementia (PDD) assessed biomarkers
of response exploring potential for a Precision Medicine approach", indicates that the P3 Parkinson's trials will be with selective enrollment based on some set of biomarkers.

Why should the correlations between PDD and AD not indicate that another trial might be required for AD? Or flip it around and ask, why has Accelerated Approval for PDD not been discussed let alone granted?

The idea of an AD accelerated approval and a P4 trial is certainly a possibility, I just think it became less likely with this poster.
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