Anavex Life Sciences Corp (AVXL)

[frrol]

The delay in FX trial is apparently mainly due to the building up of biomarker endpoints for the trial design. We published some a couple years ago but that was limited primarily to lymphocyte signals. We now have another biomarker candidate that will be presented in July. Trial planning is likely finally underway, as the company feels that we should be able to get community support in FX similar to what we got for our Rett trials.

In AD, EMA (Europe) has been the priority, and the company has not yet "proceeded" with the FDA (US). But it plans to do so "definitely this year". OLE data is not the cause of delay. (Delay possibly because company resources focused on EMA, or awaiting peer review paper to present to the FDA, or both.)