Replies to post #472876 on Anavex Life Sciences Corp (AVXL)

[Cpap21]

Missling knows what the EMA wants. Sit back and enjoy. 😉

[boi568]

The transient side effects reported in the 2b/3 do not rise to the level of "important safety issues," so you can relax about that.

Nor has the administration of blarcamesine ever resulted in safety issues across multiple indications, wide age ranges, and in longitudinal studies.

[frrol]

The presentation should have been more forthright, yes. Scientific credibility at a research conference matters. The PR did not even say "co-" primary, though the deck did. The ADL miss should have been in the deck somewhere, and briefly mentioned as arguably irrelevant according to new guidance. Dizziness is a tolerability issue, though dizziness in a geriatric population can represent a safety issue if not truly manageable.

It's notable that sleep quality was an endpoint, but to date has not been mentioned. That is disappointing at this late hour. It is also tracked in the OLE. Looking forward to the OLE results, which could be coming soon.

[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.