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November 02, 2020

Provention Bio Completes Teplizumab BLA Submission

Here is a brief preview of this blast: Provention Bio announced it completed the teplizumab rolling BLA submission for the prevention of T1DM in at-risk patients. Recall, in August 2020, FDA granted Breakthrough Therapy Designation for the teplizumab T1DM prevention indication. Below, FENIX provides thoughts on the potential Provention Bio missed filing deadline opportunity.