Applied Therapeutics Reports Fourth Quarter and Year-end 2023 Financial Results
The FDA also noted that it is planning to hold an advisory committee meeting to discuss the application.
- The FDA also noted that it is planning to hold an advisory committee meeting to discuss the application.
- Govorestat was previously granted Pediatric Rare Disease designation and will qualify for a Priority Review Voucher (PRV) upon approval.
- The Company expects a decision by the EMA in the fourth quarter of 2024.
- Full study results will be presented at an upcoming medical conference, along with results of the Diabetic Peripheral Neuropathy sub-study, which are still being analyzed.