Replies to post #488894 on Anavex Life Sciences Corp (AVXL)

[crescentmotor]

for a long time I have been thinking approval with a Phase 4 confirmatory trial....he understands the normal way.

For the life of me, I don't see an substantive justification for another standalone confirmatory trial prior to approval, at least in Europe. The data is what it is over a protracted period and the safety profile is excellent. Of course, common sense may not apply and rules/procedures do often predict outcomes and with good reasons many times. If the current SOC wasn't so lacking, I might feel differently about it. I would be the first to admit there's no slam dunk here. That's why I think the outcome of the schizophenia trial is so important.