Dive Brief:
Provention Bio disclosed Thursday that the Food and Drug Administration found deficiencies in the approval application for the company s Type 1 diabetes therapy. While not yet a rejection, the agency s feedback suggests an approval decision won t be reached by the original deadline of early July.
According to Provention, the FDA has yet to provide many details about what s wrong with the application. But the company did note how, during a recent discussion, the agency raised issues with a study evaluating the drug product used to make Provention s therapy, called teplizumab. As such, regulators told the company additional data would be needed to resolve its concerns.
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