RE:Accelerated Approval and Priority ReviewSo that's at the minimum 6 months (not to mention most logically 12 months past the 3-month CR date as per the recent FDA guidelines) after the 20th or 25th patient.
Fast Track designation (FTD) can lead to an Accelerated Approval and Priority Review, if certain criteria are met, which the FDA has previously defined to the Company to represent approximately 20 to 25 patients enrolled and treated, who demonstrate significant safety and efficacy clinical outcomes.