Anavex Life Sciences Corp (AVXL)

[frrol]

Meeting those OR endpoints didn't mean anything, unfortunately, given the missing data. ORs over 1 or 2 in those circumstances do not confirm efficacy. Math. If the missing data for those ORs are strong, not only will some subgroup ORs be better but, uncoincidentally, so will some sub-group mean changes. Math. It's the latter that would confirm (or not) efficacy, as shown in the past. Regulators will also pay attention to pTau and AB biomarkers, as shown more recently.

The way our AD trial would not lead to AA is firstly inadequate efficacy or biomarker support. If good but not great, our relatively small n will likely then be an issue for regulators. Some might not care, some might.

Unfortunately, looks like the company is struggling with getting clear dose sub-grouping. This is due to tolerance issues first surfaced by the 2a. (Noted by a couple investors here in 2016.) S1 status might be fruitful. PDD had S1 subgrouping but the Rett trials didn't. So S1 is not certain. Plasma concentrations is a possibility. Also pTau and AB clearance levels.