Aplt fda schedule

The FDA schedule for Applied Therapeutics (APLT) and its lead pipeline candidate, govorestat, is as follows:

1. FDA's Decision to Waive Advisory Committee Meeting: The FDA has decided to waive the scheduled Advisory Committee meeting for govorestat, which was previously set for October 9, 2024. This decision suggests that the FDA is confident in the safety and efficacy profile of govorestat and intends to make a regulatory decision on or before the November 28, 2024 PDUFA target decision date.
2. Priority Review and PDUFA Date: The FDA is continuing its Priority Review of the NDA for govorestat, with the PDUFA target action date remaining on track for November 28, 2024. This indicates that the FDA is on schedule to review the application and make a decision within the specified timeframe.
3. Pre-NDA Meeting Expectations: Applied Therapeutics is expecting to hold a pre-NDA meeting with the FDA in the second half of 2024 to discuss possible administrative actions related to the NDA filing submission for govorestat in treating SORD deficiency. If this meeting goes well, the company plans to file an NDA for this drug in Q1 of 2025.

In summary, the FDA's actions and the company's expectations indicate a positive trajectory for the regulatory review of govorestat, with the potential for approval on schedule or sooner.