Anavex Life Sciences Corp (AVXL)

[nidan7500]

21st CCA FDA work plan, this is NOT NEW.

https://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/scienceboardtothefoodanddrugadministration/ucm556618.pdf

We see the PLAN is the process metric/budget cycle for FDA, suggests how work is done by Gov. This is a process. CCA authorized 12/13/16. Helpful words on RWE and restore-regen (sound familiar) pg 7-9. Trying to get progress in context is tough, no matter how important the results might be.

I think we see Dr. M. trying to get work done outside the govt. plan (see MS Sweden). My guess is he is looking to generate SOME KIND OF TRIAL EVIDENCE which can be used to leverage the PROCESS. IMO, that is the reality of the current situation.

Not trying to pick an issue for contention by this but if anyone familiar w/how the FDA budget/work process can add insights then great.