Anavex Life Sciences Corp (AVXL)

[Doc328]

The FDA will review and even approve medications that do not adequately represent the US population. This will not be the issue with the FDA. Rather the issue is that 2 adequately controlled studies (which is usually 2 phase 3 but could be in phase 3 and one larger phase 2) is standard for full approval - and Anavex has only one and it was shorter than typical and not even adequately controlled as the treated patients were significantly milder than the placebo patients

If approved in the US with non-representative populations, the FDA will not place limits on racial use in the prescribing information though demographics will be mentioned. The FDA could require a Phase 4 minorities study (can be open label).