Anavex Life Sciences Corp (AVXL)

[bas2020]

It's clear to most investors that the Cog & ADL ORs were presented in the first PR and CTAD to highlight the strong responders, along with stat. sig. Cog & CDR mean scores. It was the purpose of the presentation to demonstrate patient IMPROVEMENT in the trial, differentiating it from all other past AD P3 trials. That was clearly accomplished. Since the ORs were pre-specified in the SAP that data alone was sufficient to proclaim the trial a success in meeting endpoints.

What the Sept 14 PR accomplished was not only to detail how ADAS-Cog and CDR-SB calculations alone (each with p< .025) make for an acceptable FDA trial result, but also identified 2 key biomarkers that will facilitate an AA pathway option. Whether ADCS-ADL had a p < .05 is now immaterial.

It's only the common FUDsters who keep trying to make an issue of ADL as they disregard all of the significant data that will lead to FDA approval, with the OLE likely becoming the confirmatory trial.