Anavex Life Sciences Corp (AVXL)

[Investor2014]

Regarding the current Anavex trials all them use subjective primary endpoints making placebo control a must.

In Paediatric Rett the primary endpoints are RSBQ, CGI-I, whereas in adult Rett the primary endpoints are safety related and the key secondary efficacy endpoint subjective. In mild AD subjective primary cognitive scores. In PDD the primary endpoint is CDR, which although a computerised assessment is still subjective.

It will be hard to achieve strong statistical significance for efficacy in all those trials across the treatment arms against placebo unless the effect size is larger than imo is likely and given the relatively small trials.

However, all the trials have a set of objective biomarkers that are subject to pre-specified analysis. This is important because if it can be shown that the group patients in each those trials that did best also correspond to those with the hypothesised biomarkers for response to A2-73 Anavex will likely be able to show convincing statistical significance in those subgroups.

If so that will be very encouraging both to me and I suspect also the market because it gives credence to the precision medicine paradigm that Anavex are promoting and increases significantly the chance of approval from pivotal trials selecting patients on those biomarkers.