Replies to post #508292 on 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

[boi568]

Although it's true by definition that everyone in an OLE trial is aware they are receiving the drug, Anavex has said the OLE was fully blinded as to whether a patient had previously been in the dosed group or had received a placebo. This blinding protected the early start/late start analyses and all the conclusions that could be derived from them.

[123tom]

Thanks for clarifying more. Would this be a question that a company spokesperson could answer if someone inquired?