We just spent months patting Anavex's back on how the Ema move was brilliant.
How the trial was designed with the EMA's criteria in mind, how due to lack of monitoring infrastructure a safe daily pill ticked all their boxes, how the FDA was in a state of flux, how lucky we were that Dr. Missling was an international sort of guy...
Your thesis, while well thought out and presented, sounds like doomsday cult reasoning to me.
I believe we get approval via the re-examination process.