Aldeyra Therapeutics requests FDA transfer of ADX-2191 PVRL review
ALDX•Aldeyra Therapeutics requested that the FDA transfer review of ADX-2191 for PVRL to the Division of Hematologic Malignancies 2 and withdrew its special protocol assessment. The company does not expect to start the SPA trial while its request is pending, says the regulatory path is uncertain and may be delayed, and expects the clinical program will need redesign.
1. FDA review request
Aldeyra Therapeutics requested that the FDA transfer review of ADX-2191 for PVRL to the Division of Hematologic Malignancies 2 and withdrew its special protocol assessment. While the request is pending, the company does not expect to initiate the SPA clinical trial; it said the regulatory path is uncertain and may be delayed, and expects the clinical program will need redesign.
