Anavex Life Sciences Corp (AVXL)

[growingpain]

So he instead, knowing what will come in the 50mg results, announced the endpoint as met and used the odds ratio test as a temporary patch.

This is a very far-fetched scenario, pure fantasy I would say. Especially, since when discussing the next steps, they did not mention once that the possibility that a 50mg subgroup analysis could lead to better outcomes.

He can say we missed the ADL endpoint on existing data analysis, which will be taken badly, of course, and is in fact inaccurate

I do not think anyone here believes anymore that the ADL mean change was significant. Especially, since there is a high likelihood that even the Cog and CDR-SB changes to not be significant under a standard two-tailed test.

The implication then would be the 50mg result cannot be enough for an NDA, and that's not accurate, either.

Again, I disagree here. We know FDA's preference for large multiple trials when it comes to AD. They requested data from an around 2,000-patient cohort from SAVA. Given the dropout data, the patients that achieved the 50mg dosing could be 130 or less.

Missling could release the 50mg ADL outcome, pending the rest of it later. However, that is classic cherry picking

While releasing two out of three original endpoints is not cherry-picking...

In a nutshell, my opinion is that it is almost certain that 2-73 is superior to Lecanemab in terms of safety and likely more efficacious in terms of cognition. These findings warrant a new larger trial with a single 50mg dose given before sleep and a single primary cognition-focused endpoint. Dosing before sleep could also positively impact the ADAS-ADL metric due to the relation of dizziness and confusion to function. Such a trial unfortunately would take several years to complete but it has very good prospects in terms of eventually leading to approval, especially if it is also supported by a SPA.