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Teplizumab Adcom: 10-7 Split Vote; Questions Raised on Teplizumab’s Approvability

Today, FDA held an advisory committee meeting to discuss the proposed teplizumab indication to delay the onset of T1DM based on results from the TN-10 study. The panel narrowly voted in favor (10-7) that the teplizumab benefits outweigh the risks. Recall, ahead of the adcom, FENIX correctly predicted a 10-7 vote favoring teplizumab. Below, FENIX provides a summary of key adcom panelist commentary as well as thoughts on the vote and next steps for Provention Bio and teplizumab.

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