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Re: Steady_T post# 430591

Thursday, 09/14/2023 6:50:37 PM

Thursday, September 14, 2023 6:50:37 PM

Post# of 465108
I'd like to polish this post of yours a tad:

If I understand that PR the company has just shown two strong biomarkers for an AA NDA at the same time they showed meeting two of the three endpoints they'd have needed for conventional approval.

All of which pretty likely points to a positive outcome on an AA NDA when it is filed.

It seems to me that this PR strongly supports what I've been saying for months: That Anavex would, IMO, probably be in good shape for an AA NDA but the prior information it provided gave strong evidence that it hadn't really met the ADCS-ADL endpoint (despite the "met all endpoints" claim) and, as a result, would have had a hard time obtaining conventional approval. (If I could cc this to Hoskuld, I would. :) )

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