Anavex Life Sciences Corp (AVXL)

[nidan7500]

Looking..Great catch here:

So do the introduction of new scientific domains into the development and review process. This includes the more widespread use of modeling and simulation, the greater use of real-world evidence in the pre- and post-market setting, and the adoption of better tools for collecting and evaluating more real-time safety information after products are approved.

Exactly right ref greater use of RWE...

even after products are approved

. That is just being smart and possibly a reaction to both the AD Amyloid screw ups and the recent Breast cancer-Chemo disclosures. The FDA has been acting as a gate keeper for regulatory script w/o being on the team.

IMO, the got the memo and will be closely working w/sponsors such as AVXL.