Ensysce Biosciences Receives FDA Guidance For PF614-MPAR Program
Ensysce Biosciences Receives FDA Guidance For PF614-MPAR Program
Ensysce Biosciences 收到 FDA 的 PF614-MPAR 计划指南
The meeting focused on the Company's non-clinical program for the combination product that is designed for the treatment of severe pain. The FDA provided helpful feedback and advice on non-clinical studies that are required for eventual new drug application (NDA) submission and approval. The guidance will aid in streamlining the development plans for this innovative drug candidate to bring PF614-MPAR to the market as quickly as possible.
会议重点讨论了公司为治疗剧烈疼痛而设计的组合产品的非临床计划。FDA就最终提交和批准新药申请（NDA）所需的非临床研究提供了有用的反馈和建议。该指南将有助于简化这种创新候选药物的开发计划，以尽快将 PF614-MPAR 推向市场。