Replies to post #500937 on Anavex Life Sciences Corp (AVXL)

[MrBobbob]

He also said:


“So we of course hope that this initial feedback will continue to be the case down the road and right now we have no belief why it wouldn’t, but that is of course up to the review. So we are coming in here, not that we push, but we were pulled into the submission, given probably the unmet need in Europe and also the fact that the European Union has not MRI or PET centers in all places in the countries of the European Union, like in certain countries, for example, like Hungary or Poland or Romania, there are not enough MRI centers, which would probably be needed for an antibody given its safety profile. So that’s the best we can say at this point.”

[Bourbon_on_my_cornflakes]

Actually the EMA probably off the record said " You seem to have sufficient data to submit for formal review, and if the data holds up under examination (no guarantees), it would be sufficient to get 273 approved, as we are desperate for a moderate cost oral treatment that does not require constant MRI followup, as MRI is not found equally across the EU".

[imho]

"you seem to have sufficient data to submit for formal review"

So what is your definition of what "sufficient" means to the EMA? After all, it failed the ADL endpoint. It also seems it was under-recruited, etc.

IMHO