Anavex Life Sciences Corp (AVXL)

[Homeless Economist]

No, per Anavex’s press release on its submission, OLE data are included. So I imagine these new analyses we’ve seen over the past year will be accepted, but we need this to be confirmed by the company before we can assess the success probability of a re-examination. I hope that, if the CHMP can take into account the ABCLEAR2 and 3 results, then they’ll deem the benefits to outweigh the risk.

From the PR:

The MAA is supported by data from the randomized, double-blind, placebo-controlled Phase IIb/III, ANAVEX®2-73-AD-004 trial and it’s up to 144 week open-label-extension (OLE) ATTENTION-AD ANAVEX®2-73-AD-EP-004 trial investigating blarcamesine in early Alzheimer’s disease.

https://www.anavex.com/post/blarcamesine-receives-ema-filing-acceptance-for-treatment-of-alzheimer-s-disease