Anavex Life Sciences Corp (AVXL)

[Joseph_K]

I think that's great, that ADAS-Cog decline was slowed 45% and that CDR-SB was slowed 27%. But I also think ADCS-ADL was handled very peculiarly, in a way that does not give me confidence that it really met the predefined endpoint. If you say a P3 hit all the endpoints, you ought to be able to show it. The Odds Ratio does not substitute for a comparison of the means (and not telling us what n is for the Odds Ratios is downright weird). That's where I find the report of the results lacking.

I don't like Leqembi any better than you do, but within five weeks of the original top-line announcement, Eisai stated* the mean comparisons (with p- values) for all of their cognitive/functional endpoints, and they hit them all. (I still wouldn't let my wife take the stuff if she had early Alzheimer's, but that's a different question than if they hit their endpoints. In fact, if I were forced to make my hypothetically demented wife take lecanemab or blarcamesine, with what I currently know I'd choose blarcamesine; but we're talking about efficacy meeting FDA standards, and I see ADCS-ADL as currently lacking valid statistical support.) I wish that by eight months after top-line results were first announced, Anavex would have supplied that information. I'm not saying they won't hit that endpoint, but they haven't showed it yet.


* https://investors.biogen.com/news-releases/news-release-details/eisai-presents-full-results-lecanemab-phase-3-confirmatory