Sesen Bio Announces Successful Pre-BLA Meeting with FDA for Vicinium®
Sesen Bio, Inc. (SESN)
Last sesen bio, inc. earnings: 11/12 07:00 am
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Source: Business Wire
FDA Recommends Accelerated Approval Pathway FDA Indicated No Additional Clinical Trials Necessary for BLA Submission Company Expects to Initiate Submission of the BLA in 4Q 2019 Under Rolling Review CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Sesen Bio (Nasdaq:SESN), a late-stage clinical company developing targeted fusion protein therapeutics for patients with cancer, today announced that it has completed a successful Type B Pre-Biologics License Application (BLA) meeting regarding the approval path for Vicinium for the treatment of patients with high-risk, Bacillus Calmette-Guérin (BCG) unresponsive, non-muscle invasive bladder cancer (NMIBC). The Company has reached alignment with the U.S. Food and Drug Administration (FDA) on an Accelerated Approval Pathway for Vicinium along with Rolling Review, and the Company expects to initiate submission of the BLA in the fourth quarter of 2019
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