Replies to post #447111 on Anavex Life Sciences Corp (AVXL)

[Joseph_K]

Soumit Roy ... inquired: “And what are the plans for US approval?” Missling answers: “We have the ongoing ATTENTION-AD study ongoing and that’s part of the package of the application with the Phase 2b/3 study.”

I think your interpretation makes sense, though Missling's reply is slightly vague; even when Missling does specify timeframes it's been hard to know when and if the follow-through would occur.

clinicaltrials.gov says:

Study Completion (Estimated)
2024-07-31

Once Anavex has the raw data it wants, there should be very little delay, as they don't need to wait around for biomarkers from the OLE as (IMO) it's just efficacy that needs bolstering, and crunching the raw data for that can be done in minutes (as the applicable statistical programming should have been completed beforehand). There's also no reason Anavex couldn't be talking seriously with the FDA about submitting the NDA before the OLE has ended, even if the OLE data is necessary, as the OLE is unblinded. Hopefully all the NDA sections apart from efficacy will have been completed before the end of the OLE. Under that scenario, perhaps September is when the NDA would be filed? I forget the precise timelines, but I believe that's late enough to give the EMA a good headstart, as Missling has indicated he wants. Come October I'd be antsy if the NDA has not been filed. I'm not even sure there's strong reason to wait for the OLE to end before filing using interim data, but I wouldn't find fault with it.