Anavex Life Sciences Corp (AVXL)

[boi568]

Looks like Missling has pivoted from the first PR in his measures (OR success for ADAS-Cog and ADL), indicating a traditional approval path, to measures and biomarkers more suitable for Accelerated Approval.

The difference being, with biomarker support now available, Anavex has decided that AA is the better route. The brain volume data will probably be the key. Has anyone else ever demonstrated success on this measure? I would think it holds more clinical significance the AB ratios, which are also good. It's a more direct, and clearly relevant, indicator.

As for ADL, I expect the OLE data to show continuing beneficial effects, but that endpoint has been abandoned for purposes of the AA path. Given the early stage of the disease in the trial population, it's likely that 48 weeks was just not enough time to get to statistical significance. Anavex will impute placebo results from a more general untreated patient curve in the OLE as support here. I expect that will show strong results over the additional 96 weeks.

I am looking forward to the breakouts, which are likely to be published in an article, preferably before CTAD.