Anavex Life Sciences Corp (AVXL)

[12x]

Here is one recent FDA’s example of Amylyx ALS drug submission illustrating many of the MB discussion points. Slide 36 shows FDA recalculated the p-value using ITT with MMAR instead of company provided mITT with LOCF.

Anavex slides labeled ITT analysis so if that’s the case, the reported results should be in line with FDA expectation. Even if mITT (or PP) was used as some suspected, the p-value impact is small given both placebo and treated baseline ADAS-cog values are both 1 point lower than mITT baseline. The MMRM use random treated group 48week samples to impute the dropout patient’s 48w samples resulting no change in 48w value.

https://www.fda.gov/media/157288/download