Anavex Life Sciences Corp (AVXL)

[Anshu2]

No. AA can be granted irrespective of the timing of confirmation trial. SRPT’s first drug (Exondys) got the AA in 2016 and the confirmation trial only started in mid-2020 with readout in 2026 (?). There were trials running during AA approval process, but FDA asked for a newly designed confirmation trial.

From a site: US data show that, of 23 accelerated approvals granted in 2010-20 to non-oncology drugs, only four had converted to full approvals through clinical confirmation as at the end of 2020, taking an average of 3.5 years to do so.

However, FDA does like to see the promise of completion of the confirmation trial — in ongoing case of SRPT’s gene therapy AA (AdCom panel on Friday and decision on 5/29), the confirmation trial is fully enrolled and finishing in a few months. I think FDA likes that.