Anavex Life Sciences Corp (AVXL)

[Investor2014]

To me, in the call yesterday it seemed very clear that the MRI brain volume data, correlated with cognitive outcomes, is the key biomarker Anavex will rely on, and it sits in the N category of the A/T/N framework. It is also, as things stand, the only pre-specified biomarker in the Phase 2b/3 trial that is likely to be accepted by regulators.

To think that a relatively small trial, which missed its ITT endpoints, is going to educate regulators into accepting in-trial generated hypotheses centred on biomarkers that are, so far, neither established nor widely accepted, is unrealistic.

My hope is that the MRI data and its correlations with cognition can still swing the opinion, and I very much look forward to seeing the paper on this.