Anavex Life Sciences Corp (AVXL)

[Investor2014]

Interesting observation. Not sure if there is anything special about the number 120 other than perhaps it is a good minimum n for showing statistical significance with a drug that actually works.

A US sponsor conducting trials internationally is now very common and the FDA themselves says there is "Less regulatory red tape".

Foreign Study Conducted Under IND 
 • When a study is conducted under an IND but is located outside of the United States, the study still must comport with all relevant FDA regulations as if it were being conducted within the United States 
 • A Sponsor is not required to conduct an FCT under an IND in order to use it as support for an NDA or IND

FDA Perspective on International Clinical Trials

Looks like the presentation is from 2014. Worth reading through for an insight to why Missling went abroad and yet no doubt aim for FDA approval supported by Fadiran's experience.