Anavex Life Sciences Corp (AVXL)

[Investor2014]

Let's quote all of that plan as it is publicly stated so far:

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.

Anavex Life Sciences Reports Fiscal 2023 Second Quarter Financial Results

When this is read for what it says in context, it should be clear to most that the company is referring to a P3 Confirmatory Trial that will be initiated in parallel with discussing biomarker findings with regulatory authorities.

This independent and regardless of whether or not Anavex might be granted Accelerated Approval .

Regulators prefer that sponsor have independently initiated a Confirmatory Trial before an AA decision. As in the case of the Lequembi approval, where their P3 trial had preliminary readout data before the AA decision and has now achieved traditional approval on an optimal timeline (regardless of opinions about the drug).

This proactive approach from sponsor shows a higher likelihood of being granted AA. I previously quote a paper referencing 170 AA decision, where 70% of the approved cases had initiated a confirmatory trial prior to the AA decision.

It is a good move by Anavex because, if AA is granted the confirmatory P3 trial is already well underway hopefully then sooner leading to full traditional approval.

Patients now have a choice between an expensive provisionally approved drug/treatment plan or joining a P3 trial for free, where the trade off is not knowing whether receiving drug / placebo during the trial period. In the P4 Confirmatory Trial scenario patients would be paying to participate in a clinical trial, although potentially with no risk of receiving placebo.

Should AA not be granted again the timeline for potential traditional approval has been optimised by the company opting to run a P3 confirmatory trial independent of an AA decision outcome and with the expectation that the confirmatory trial has the desired traditional approval outcome.

Try to think this through versus the scenario of passively waiting for the FDA to maybe grant AA and then requesting a P4 trial or Anavex having anyway to start a P3 trial - there are no advantage that I can see to that scenario.