PharmaTher expects to submit minor amendment to CRL by end of February

PharmaTher (PHRRF) announced that the Company is on track to resubmit information to the FDA by end-February 2025. This resubmission, which addresses the deficiencies classified as MINOR in the complete response letter provided by the FDA dated October 22, 2024, is a significant step towards obtaining FDA approval. The Company expects to receive a new approval date for a Q2-2025 FDA approval. As noted by the FDA in the CRL, the resubmission to this CRL will be considered to represent a MINOR AMENDMENT, given that the deficiencies have been classified as MINOR. The FDA requested new and updated information and clarifications related to drug substance, drug product, manufacturing, and microbiology. The FDA did not express concern about the stability of the ketamine submission batches, which achieved 18 months of stability without issue, and no new preclinical and clinical studies were requested. PharmaTher is fully committed to the potential of ketamine and is dedicated to its development and approval.