Anavex Life Sciences Corp (AVXL)

[nidan7500]

F1ash

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.

IMO, you are pointing out some of the new variables that bio investors will need to manage and deal with. There has been little emphasis in the past on the IND process (have seen it described as a given). All of that will change effective "precision Medicine-RWE-Clinical Hold" and the drive to not go with PIII pass/fail BUNGEE JUMPS.