Anavex Life Sciences Corp (AVXL)

[bas2020]

I fully expect them to be seeking FDA guidance for NDA submission for Rett in total, as the Excellence results clearly demonstrated efficacy and safety, even if the results weren't technically stat. sig., due to the extraordinarily large placebo response, which can easily be explained and likely accepted by regulators. Regulators will review the entirety of data when making their decision, including the years of extension data demonstrating QoL improvements and substantial reduction in seizure frequency.

In the meantime we wait for the peer-reviewed journal article and MAA submission for AD.