Anavex Life Sciences Corp (AVXL)

[skitahoe]

I really don't remember if the EMA and UK try for the same target days, but with priority review the UK is now shooting for 120 days after submission, it had been 150 days, If someone knows the EMA target please let us know but we know the FDA takes 6 months after they accept an application, they establish a PDUFA date. I believe the FDA often spends a month in approving an application, so their total process can be 7 months for priority review. The diseases we're discussing should get priority review from any of the regulators.

I don't know why Missling would choose the slowest to approve, if that's truly the case. I suppose if one wanted to submit to multiple regulators and have all approvals happen nearly simultaneously you'd submit that way, but I've never heard of such a thing. I don't believe anyone suggested he was employing such a strategy.

I believe the FDA is generally considered the gold standard and probably the toughest approval to get, but after them I don't know how they rank, or if Europe is considered to be the easiest. Any regulatory approval is a good start, but they won't stop after the first whoever it is.

Gary