Anavex Life Sciences Corp (AVXL)

[DrJan]

These are promising new subgroup data, and there are many reasons to believe blarcamesine works in AD and can be approved. However, with these data I do not understand why they have not started a follow-up study already. Now they risk a delay of 2 years if EMA is not satisfied.
Sabagh did not report on the missed other co-primary endpoint (ADCS-ADL) and mentioned dizziness and the lack of ARIA’s and that the AE’s were transient, mostly mild, manageable, and comparatively good. However, nothing about the marked increase in SAE’s, which is a bit strange of course.
Pharma regulations are very strict and closely watched, also in Spain. When presenting for HCP’s the message has to be balanced and fairly representing the study results. You cannot just report the best results and ignore important safety issues. The data is good enough to be more open about it and that will also provide the necessary credibility.