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georgejjl

11/03/22 7:31 PM

#381494 RE: frrol #381493

frrol: I agree with the following:

We'll likely be getting important color on the AD TLR. An overall reduction in % cognitive and functional decline will be crucial to compare to Lecanemab, but stratification on our pre-defined cohorts - dose, S1 and APOE status, and cognitive baseline - will be of great interest at CTAD. And regulators. It's where precision medicine meets the road and hopefully there are some good correlation coeffs.



GOD bless,
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boi568

11/03/22 7:57 PM

#381496 RE: frrol #381493

I think we are at the point, four months down the road, where there are only two viable possibilities that can explain the PR delay. Either the results are so borderline/mixed that Anavex is scrambling to maximize its presentation, or they have good to excellent results that they are busily integrating into what is known about the other clinical trials and the emerging fundamentals of S1R science.

The stats seem to suggest that the first possibility requires a narrow cognitive improvement window of only about .15 to .35 SD, while the excellent 14-week PDD Episodic Memory result, the clinically strong Rett results, the common biological markers between those indications, the broad genomic transcription study result, and the increasingly clear research into the upstream nature of 2-73 that ties this together, all indicate the latter. This second option happens to be Missling's MO, and fits his view of 2-73 as a platform drug. The successful snagging of an oral presentation and the volunteering of peer reviewed publication are also favorable signs.

There is no reason to believe at this late date that the 2b/3 trial outright failed its primary endpoints, or failed on safety.

So I am optimistic we have a win.
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frrol

11/03/22 8:48 PM

#381498 RE: frrol #381493

Should add: once AD TLR is 'out of the way', company will apparently resume announcements about pipeline advancement (3-71, FX, undisclosed, etc).