Anavex Life Sciences Corp (AVXL)

[Hoskuld]

Anyone who thinks that the EMA asked Anavex to submit has to admit now that this did not happen. The fantastical thinking that the EMA was OK with missing the ADL endpoint and was OK with a single study, is clearly flawed. How does the company rescue this application when the CHMP outright said the blarcasemine study did not meet the burden of proof that it works for a set of patients that they clearly showed efficacy per the initial study (WT showing 50% reduction in progression)? It was interesting that they gave this as the main reason - why did they conclude this when stat sig was there and the WT group was prospective?