Replies to post #130733 on Anavex Life Sciences Corp (AVXL)

[XenaLives]

FDA comments on RMAT:

https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM585414.pdf

Note - even though these policies are "nonbinding recomendations", I don't beleive there is anything stopping the FDA from approving a trial with these guidelines if they wish to.