Anavex Life Sciences Corp (AVXL)

[polarbear77]

Exactly Mikesc, imagine applying for our AD IND in Fall 2017 prior to this new AD guidance document was approved and released by FDA?

Any critics and chronics here want to make the case that we should’ve submitted an Alzheimer’s Disease ph2/3 trial IND under the old outdated CNS disease protocols?

Especially when Dr Gottlieb had already made clear reference to the upcoming changes and new streamlined trial guidances back in September 2017?

GLTAL


And thank you for the link:
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM596728.pdf