PharmaTher granted post-CRL clarification meeting request by FDA

PharmaTher (PHRRF) Holdings announced that the Company requested a post-complete letter clarification meeting in response to the FDA issuing a complete response letter, dated October 22, 2024, for the ketamine Abbreviated New Drug Application, which was assigned a Generic Drug User Fee Amendments of 2022 goal date of October 29, 2024. On November 12, 2024, the FDA granted the Meeting scheduled for November 29, 2024. Due to the U.S. Thanksgiving Holiday and scheduling conflicts of attendees from its CDMO partner, the Company has requested to reschedule the Meeting for the following week. The Company requested the Meeting to ensure responses to the CRL align with the FDA’s requests, leaving nothing to chance. The Company will announce the new Meeting date once it becomes available, propose a timeline for the resubmission to this CRL, and continue to provide updates as they occur. As announced on October 23, 2024, the deficiencies cited in the CRL are classified as MINOR, and the resubmission to this CRL will be considered a MINOR AMENDMENT. 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.