Anavex Life Sciences Corp (AVXL)

[boi568]

The EMA and FDA have somewhat different procedures that help explain how things are unfolding now. The EMA has a pre-submission process as well as a submission process, while the FDA has only a submission process. Anavex, with its ongoing but incomplete OLE, is not yet ready to provide a completed submission to the FDA (or the EMA), but it clearly has enough to get an EMA pre-submission process underway. That's why we aren't going to see an NDA attempt at the same time as the beginning of the current EMA effort.