What does 'FDA accepts our application' mean?
The filing passed completeness review — the PDUFA clock starts now.
The FDA has 60 days to decide whether an NDA/BLA is complete enough to file. Acceptance triggers the review clock and, usually, the PDUFA date disclosure that follows within days.
A refusal-to-file (RTF) — the application never entering review — is the harsher, earlier failure mode that acceptance rules out.
See it live: the catalyst calendar · status-change feed