Anavex Life Sciences Corp (AVXL)

[Steady_T]

I did a little deeper research on Accelerated Approval and found this.

Apparently a surrogate endpoint is not a requirement but is one of two possible criteria. The other one is a clinical endpoint as described below.

Looks like 2-73 achieves them both. Bolding is mine.

? A drug that treats a serious
condition AND generally
provides a meaningful
advantage over available
therapies AND
demonstrates an effect on a
surrogate endpoint that is
reasonably likely to predict
clinical benefit or on a
clinical endpoint that can be
measured earlier than
irreversible morbidity or
mortality (IMM) that is
reasonably likely to predict
an effect on IMM or other
clinical benefit (i.e., an
intermediate clinical
endpoint)

Accelerated Approval would require an P4 trial to be set up and run. Regular approval process would not require a P4, just the usual monitoring program for SAE and AE.

Priority Review can be requested at NDA submission time. Priority Reivew designation results in an FDA decision on the NDA in 6 months as opposed to the usual 10 months.