RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Type C Meeting TimingsAnd because I have to keep repeating myself an Accelerated Approval/Subpart H –
Unlike Fast Track, Priority Review, Breakthrough, and RMAT which reduce FDA’s review time, Accelerated Approval shortens the Sponsor’s clinical development time – For serious conditions with a meaningful advantage over available therapy – Permits the use of a “surrogate endpoint” that is likely to predict clinical benefit (e.g., ORR, PFS, mOS, and tumor shrinkage) (which ONCY has demonstrated in and spoken about multiple times)– Sponsors required to conduct post-marketing studies to confirm benefit (i.e., confirmatory trials) – FDCA § 506(c); 21 CFR 314.500 3