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 計劃指南
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.
會議重點討論了公司爲治療劇烈疼痛而設計的組合產品的非臨床計劃。FDA就最終提交和批准新藥申請（NDA）所需的非臨床研究提供了有用的反饋和建議。該指南將有助於簡化這種創新候選藥物的開發計劃，以儘快將 PF614-MPAR 推向市場。