Anavex Life Sciences Corp (AVXL)

[Steady_T]

Missling's Q&A.

We also have the possibility to now, because of a new data on a biomarker, which is a surrogate biomarker of the pathology, to advance the program faster than we thought into accelerated approval since that has been also the case for two previous approvals in the Alzheimer’s field, and that is very encouraging for us to see that.

The next question is, will the AD NDA be submitted before the confirmatory trial is completed? The answer is after discussion with the agency for Accelerated Approval Pathway, this would be the path which was also given to the other accelerated approval company approvals. So this could be the case as well. Otherwise, it would be not accelerated approval if you need a study to begin with. So that is the goal of getting the drug approved before completing a confirmatory second trial.