Replies to post #427920 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

The intention to apply for AA potentially with the OLE showing continued stabilisation or improvement of whatever surrogate endpoint biomarker(s) confirms that we have a P2b trial that met all endpoints and not a pivotal P3 trial.

No issue with getting AA from the P2a trial regardless of the OLE serving as the confirmatory trial vs initiating a P3 trial imo.

Of course getting away with just the OLE would be even nicer.

I agree with x12 that met all endpoints actually means as a P2b.

[12x]

Here are Anavex Q2 and Q3 PR. I don't think it's difficult to draw one's own conclusion.

5/8/23 Q2 PR
Newly available preliminary efficacy results of surrogate biomarkers from the ANAVEX®2-73-AD-004 study; allowing initiation of discussions with regulatory agencies for Accelerated Approval Pathway for ANAVEX®2-73 (blarcamesine) in Alzheimer’s disease with convenient oral treatment.
With newly available preliminary efficacy results of surrogate biomarkers, we consider initiating discussions with regulatory agencies for Accelerated Approval Pathway for ANAVEX®2-73 (blarcamesine).
Alzheimer’s disease: Full data ANAVEX®2-73-AD-004, including newly available preliminary results of surrogate biomarkers of pivotal Phase 2b/3 clinical trial. The Company intends to discuss these findings with regulatory authorities in the context of the ongoing clinical development of ANAVEX®2-73 in this indication, with the goal of providing a much-needed treatment to the millions of patients living with Alzheimer’s disease with a convenient once-daily oral treatment. The Company plans to proceed in parallel with the initiation of a confirmatory Alzheimer’s disease study.

8/8/23 PR
Newly available preliminary efficacy results of surrogate biomarkers from the ANAVEX®2-73-AD-004 study in Alzheimer’s disease with convenient oral treatment to be released in the second half of 2023.
Q3 Alzheimer’s disease: Full data ANAVEX®2-73-AD-004, including newly available preliminary results of surrogate biomarkers of pivotal Phase 2b/3 clinical trial. The Company intends to discuss these findings with regulatory authorities in the context of the ongoing clinical development of ANAVEX®2-73 in this indication, with the goal of providing a much-needed treatment to the millions of patients living with Alzheimer’s disease with a convenient once-daily oral treatment. Company expects to announce data in the second half of 2023.