Anavex Life Sciences Corp (AVXL)

[Investor2014]

No AA is granted because a P3 is planed, initiated, close to readout or even readout and data available. Therefore Anavex said in parallel.

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.

Here parallel refers to the AA pathways discussions that the company intends to have with regulators.

There is no difference to how fast AA might be granted between running a confirmatory P3 or P4 trial, because the discussion about AA pathways and potential grant of AA follows a trial with surrogated biomarker(s) likely to infer clinical benefits e.g. the Anavex P2b/3 AD trial.

The benefit in timing comes from how soon after AA that full traditional approval can be granted. As per the lequembi example.

The likelihood of having AA granted is improved by proactively having made sure through a P3 trial that data will be available on a set horizon for either granting full approval or withdraw AA.