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Re: Joseph_K post# 415906

Thursday, 05/18/2023 9:45:02 AM

Thursday, May 18, 2023 9:45:02 AM

Post# of 463348
The 2% is my estimate for chance of approval under AA with the assumption that an additional trial is underway. My estimation of the likelihood after an additional P3 (whether traditional or PM) is complete would be higher but still much lower than most on this board believe. Rett is Anavex's better chance.

you must think the P2b/3 statistical results were grossly misrepresented, and Missling's biomarker comments overblown


yes. One of the coprimary endpoints not met, one sided vs two sided stats, ITT population was actually PP population by definition in the now removed error filled slide-deck, Imputation measures were not addressed, OR would not have been at the top of the statistical hierarchy, proper dose not known...... All of this was obvious to careful observers after the disastrous morning CC Dec 5.

The FDA knows aducanumab AA approval was a mistake - heads have gently rolled. Lecanemab AA was appropriate -- look at their well presented data. The FDA AA decision, though based on the P2 and amyloid PET SUVr reduction, was not made until after the FDA knew the TLR and more details of the successful P3 - completely different situation than Anavex is in. If blarcamesine is approved it will be more successful than lecanemab but Missling needs to get it across the finish line and then make up for a 4 year lag. The chickens must hatch.
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