Ensysce Biosciences Announces FDA Agrees With Ensysce's Proposed Plans On Approach To Manufacture PF614

Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company pioneering next-generation pain and central nervous system therapeutics designed to minimize abuse and overdose risk, today announced that the Food and Drug Administration (FDA or Agency) provided Written Responses to a meeting request.

Ensysce had requested guidance on its approach to the manufacture of PF614, wanting to understand the appropriateness of regulatory starting materials (RSMs) and specifications for PF614 drug substance and the RSMs.

In its written responses, the Agency agreed with all of Ensysce's proposed plans. These responses provide Ensysce with a direct path to commercial production of PF614, which is currently being initiated with its manufacturing partner, Purisys, LLC, a subsidiary of Noramco, LLC.