Replies to post #416288 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

The quarterly cc answer from Missling further shows that the planned Confirmatory Trial is not a P4, which is only initiated post Accelerator Approval as requested by the FDA and not proactively planned and initiated prior to AA.

Christopher Missling
Yes. Excellent question. So the patient on the extension study actually was given a name. It's called the ATTENTION-AD Study, and it's going over 96 weeks. We have been heard from KOLs that actually this extension study could be the confirmatory study of the ANAVEX2-73 Phase II, Phase III study itself. So we want to basically put this in context and see how this will progress. Accordingly, so we might already have started this confirmatory study with that open-label study, but it will be determined in discussion with regulatory agencies. But we would, of course, be able to, without a problem, initiate a study, if so required, at any time.

Based on: FDA Grants Accelerated Approval for QALSODY™ (tofersen) for SOD1-ALS, a Major Scientific Advancement as the First Treatment to Target a Genetic Cause of ALS

The approval of QALSODY was supported by 12-month integrated results from VALOR and its OLE comparing earlier initiation of tofersen (at the start of VALOR) to delayed initiation of tofersen (six months later, in the OLE), that were published in The New England Journal of Medicine.

Provided that the P2b/3 AD trial has acceptable Surrogate Biomarker(s) that continues to be maintained or improves during the OLE that trial, that might stand in as the Confirmatory Trial already initiated and expected to complete 2024-07-31.

So now it seems Anavex is holding off initiating a Confirmatory P3 trial until actual discussions with the FDA has taken place, who knows when.... If the answer is affirmative, a question is then if the ATTENTION AD data can be examined before 2024-07-31 and whether that matters since Anavex is determined to pursue the RDP Voucher based on the EXCELLENCE trial leading to approval first.

Bottom-line is no AD approval is likely in 2024, let alone this year as some have been trying to sell us on.