Anavex Life Sciences Corp (AVXL)

[F1ash]

Would the FDA announce their correspondence with Anavex?
Is indifference from RETT REALLY what you wish to hear from
4/25 event?

I believe It was claimed by a poster here that CM directly confirmed that the updated resubmission was already in the hands of the FDA on or before 3/15.

So, on or before 4/15 Anavex should either know if they are clear to proceed with the Rett trial, or if the new application is also experiencing some kind of clinical hold similar to the initial application.

The FDA traditionally will not notify anyone, outside of the company, one way or the other. (As an illustration; Way more than 30 days passed after the initial application and investors where left to guess at the reasons the trial approval was never announced because the FDA doesn’t PR that information)

“• An IND goes into effect 30 calendar days after FDA receives the IND, unless FDA notifies the sponsor that the trials described in the IND are subject to a clinical hold, or on earlier notification by FDA that the trials may proceed (21 CFR 312.40(b)).


https://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/UCM082022.pdf

So it seems reasonable to expect that if Anavex has the approval to proceed, they would use a Presentation Event about Rett to announce that good news, unless they announce it prior to the presentation for some reason.

If Anavex doesn’t announce clearance to proceed at the 4/25 event, then investors should probably conclude the FDA still has questions and has A2-73 for Rett on Clinical hold again imho.