Anavex Life Sciences Corp (AVXL)

[Steady_T]

The way you phrased your question assumes that another P3 is required. Some people on the board think that is the case, others do not.

Either way, strong OLE data will be a positive in considering a drug application, especially the longer term 96 week OLE data. In general OLE data is not considered as strong as data from a random controlled trial.

Based on the "encouragement" from the EMA to file the MAA one might conclude that the data they saw was sufficient. Conversely the EMA may have seen the 48 week data and said it looks good so far but the 96 week data is what we really want to see, so make sure to include that in your MAA.

For me, I just accept that the process has started, the initial pass at the data was enough for the EMA to say go forward. Beyond that we really don't know much more. I am comfortable with the uncertainty.