Anavex Life Sciences Corp (AVXL)

[Biostockclub]

Released today, December 19, 2019

New FDA draft guidance

Wherein the FDA opens the door to approvals w/ p-value > 0.05. (serious or rare disease w/unmet medical need). Also approval may be based on single trial in certain circumstances.
(Sounds like Janet Woodcock et al finally made their point.)


Most interesting parts are in the “rare” section and best one there, imo, was telling sponsors working on rare disease that their FIRST IN HUMAN trials should maybe be designed to support a marketing application. (!)

Were these the reason to idle the US Rett trial, New, more patient favorable (both meanings of “patient”) approval terms?

https://www.fda.gov/media/133660/download

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