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Hosai

04/25/24 11:49 AM

#457605 RE: mrplmer #457603

But we already know it was significant...the Sept 2023 PR from Anavex (overseen by Dr Jin who has 25 years with FDA as a lead on AD trials) had ADAS COG with a p value of 0.026 i.e 2.26 in a 100 chance that the improvement was due to chance. The FDA draft guidance now states this is the end point they care most about now, not ADL as it's too difficult to show in early AD studies (though Missling did say ADL was trending in right direction in latest call).

Steady_T

04/25/24 1:10 PM

#457616 RE: mrplmer #457603

Different diseases with different disease pathways. Not an apples to apples comparison.

If the Results for Rett weren't significant ao why would they be for Alz