Following a late-cycle review meeting with the U.S. FDA in September and the agency’s decision to skip the advisory committee meeting, expectations were high heading toward the PDUFA date for Applied Therapeutics Inc.’s priority NDA for govorestat in galactosemia. So the complete response letter issued by the FDA just ahead of the Nov. 28 PDUFA date, citing deficiencies in the clinical application, caught nearly everyone off guard.