Anavex Life Sciences Corp (AVXL)

[Investor2014]

Yes and especially as Anavex after the P2b/3 readout in Dec 2022 said they would initiate a confirmatory trial in parallel with exploring regulatory approval pathways.

These are promising new subgroup data, and there are many reasons to believe blarcamesine works in AD and can be approved. However, with these data I do not understand why they have not started a follow-up study already. Now they risk a delay of 2 years if EMA is not satisfied.

The initial Biogen / Eisai conditional approval was supported by a soon to read out confirmatory P3 trial, which is what the FDA now require to ensure that conditional approvals are followed up in a timely manner with a confirmatory trial.

Missling then referenced an unnamed KOL with a claim that an OLE can take the place of a confirmatory RCT - that was all complete BS!

If an MAA is not filed and approved, Anavex would have lots several years (not just 2) before a confirmatory AD trial can readout and potentially lead to a regulatory filing.