JDRF is encouraged by the news from Provention Bio that they have received proposed labelling and other details from the FDA for their Biologics License Application (BLA) for teplizumab for the delay of clinical type 1 diabetes in at-risk individuals, and that they are continuing to advance their plans for commercial launch. JDRF looks forward to the FDA’s decision on Provention Bio’s application in the coming weeks.

-JDRF