Replies to post #432560 on Anavex Life Sciences Corp (AVXL)

[Joseph_K]

I don't think lecanemab is worthwhile, but you can't call the drug trial a failure, as seems popular here. It clearly hit its sole primary endpoint with statistical significance and backed it up with statistically significant results on an accepted biomarker. See https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9768996/

It also had lots of ARIA problems, the reduction in cognitive decline was unimpressive, debatably clinically meaningless, etc. But note that our new Chairman of the Scientific Advisory Board, Sabbagh, has been a real booster of lecanemab (and I think maybe even supported approval of Aduhelm), and Dr. Grimmer regards lecanemab as a worthwhile advance.

As even Doc has said, if blarcamesine gets approved, it will be a much greater success than Leqembi; but at this point it looks like lecanemab's supporting stats on efficacy were cleaner than what Anavex has shown. Maybe blarcamesine would have had obviously better statistical support than lecanemab if the trial had had a larger population and ran longer (or even without that if CDR-SB had been primary and ADCS-ADL secondary!), but that wasn't the setup. I join Boi in believing that the FDA would be foolish not to approve 2-73 in light of its safety profile (and ease of administration -- think of the patients who can't readily go for MRIs), but if they're sticklers on the statistics and trial length ...

I like sticking to the facts.