Anavex Life Sciences Corp (AVXL)

[Steady_T]

The FDA will be most concerned with the primary endpoints and the stats used to calculate them.

Correlations to a different disease are going to be a minor item, probably in the footnotes or an addendum.

Same for the genomic data, unless specified in the outcome measures, which some of that is. Even so, the genomic data is supportive of the primary endpoints. The genomic changes are not accepted biomarkers so they won't have significant weight. They will support the theory of the MOA.

Safety data will be included from other trials. But how much attention do you think the FDA will pay to Rett trial safety? Different disease, different demographics. It's worth a paragraph or two but the bulk of the safety data will be about the AD trials and the OLE trials. That is the population that the drug is being targeted for.