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Re: Doc328 post# 462198

Thursday, 07/04/2024 3:08:52 PM

Thursday, July 04, 2024 3:08:52 PM

Post# of 471396
It looks like the AD p2b/3 full data results will be released in the following 4 upcoming events. The way the presentations/releases are sequenced makes one wonder whether the trial was much more successful (outside the co-primary ADCS-ADL) than people realized. It also seems Marwan is taking over the medical conference presentation duty from MS.

1. Blarcamesine in Early Alzheimer Disease Phase 2b/3 Randomized Clinical Trial (AAIC 2024 7/28) - "In this phase 2b/3 randomized clinical trial, we found that among participants with early AD, blarcamesine significantly slowed clinical progression on prespecified primary outcome global and cognitive measures at 48 weeks in the ITT population. These results suggest that blarcamesine may be an effective, safe, and novel scalable oral treatment for early AD."
To announce final p2b/3 results: first time disclose ADCS-ADL results (not stat sig) but Cog13, SB, and CGI-I stat sig

2. Pre-specified SIGMAR1 Gene Variant Analysis in Phase IIb/III Trial Supports Precision Medicine Mechanism of Action (MoA) with Improved Treatment Effect of Blarcamesine in Early Alzheimer Disease (CTAD 2024)
Pre-specified SIGMAR1Gene Variant subgroup must be significant. Otherwise, why present it in CTAD?

3. Analysis of RNA sequencing (RNA-seg) of the Phase 2b/3 data expected by mid-2024 (Anavex June Presentation)
Must be good results? Otherwise, why call it out?

4. Data from the blacamesine Phase 2b/3 ANAVEX2-73-AD-004 trial to be published in an upcoming peer-reviewed journal (Anavex June Presentation)
The company has disclosed most of the full data already at this point. The dose-response subgroup might be the only thing new if not disclosed in AAIC-2024 and biomarkers.

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