Biotech Values

[DewDiligence]

>> When would you expect the FDA to actually give GENR Fast-Track status for Squalamine? Is there a typical timeline the FDA likes to grant Fast-Track status or is it totally random in general. <<

GENR has to request a Fast Track designation for the AMD program, and I expect the company to do that this year. The FDA will almost certainly grant the request.

However, Fast Track does not guarantee a six-month review of the NDA. Priority Review is distinct from Fast Track, and it must be explicitly requested at the time of the NDA submission: #msg-1643465

Fast Track is a necessary but not a sufficient condition for Priority Review.