Anavex Life Sciences Corp (AVXL)

[Investor2014]

Here: Anavex Life Sciences Reports Fiscal 2023 Second Quarter Financial Results

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.

As far as I can tell from the recent data PR, the results presented was based on Completer rather than ITT population analysis accounting for dropouts. I have doubts if that will wash with the EMA as reliable results from a proper RCT.

In Dec 2022 readout PR the company claimed:

ANAVEX®2-73 treatment met the primary endpoints and reduced clinical decline on the global cognitive and functional scales over 48 weeks in the analysis of the Intent-to-treat (ITT) population.

This claim continues to strike me as more than odd especially with respect to the analysis being from the ITT population, this considering that we now have full sight of the TEAE related dropouts and a post hoc Completer analysis! I don't think adding OLE results to Completer analysis results will convince any regulator.

The right decision IMO would have been the one Anavex cited in their 2023 Fical 2nd Q PR. Having got that confirmatory P3 on the way would have increased the chances of a conditional approval just as we have seen with the recent FDA Mab approvals.