Sesen Bio 8-K Shows Co. Participated In Type C Meeting With FDA; FDA Agreed To A Majority Of Co.'s Proposed Protocol, Statistical Analysis Plan Design Elements For An Added Phase 3 Trial For Potential Resubmission Of Vicineium Application
Sesen Bio 8-K Shows Co. Participated In Type C Meeting With FDA; FDA Agreed To A Majority Of Co.'s Proposed Protocol, Statistical Analysis Plan Design Elements For An Added Phase 3 Trial For Potential Resubmission Of Vicineium Application
On March 28, 2022, Sesen Bio Inc., (the "Company") participated in a Type C Meeting with the U.S. Food and Drug Administration ("FDA"). During the meeting, the FDA agreed to a majority of the Company's proposed protocol and statistical analysis plan design elements for an additional Phase 3 clinical trial that the Company plans to conduct for potential resubmission of a Biologics License Application for Vicineum™ for the treatment of non-muscle invasive bladder cancer. The Company plans to further engage the FDA in the coming months to align on the remaining outstanding items related to the additional Phase 3 clinical trial.
2022年3月28日，SESEN Bio Inc.(“該公司”)參加了與美國食品和藥物管理局(FDA)舉行的C型會議。在會議上，食品和藥物管理局同意了該公司提議的方案和統計分析計劃設計要素中的大部分，該公司計劃進行額外的第三階段臨床試驗，以可能重新提交用於治療非肌肉浸潤性膀胱癌的Vicineum™的生物製品許可證申請。該公司計劃在未來幾個月內進一步與FDA接觸，以協調與額外的第三階段臨床試驗相關的剩餘未完成專案。
譯文內容由第三人軟體翻譯。
