US FDA Panel Nod For Teplizumab To Delay Type 1 Diabetes Comes On Strength Of Single Study
Advisory committee members say Provention Bio’s meta-analysis of biomarker data from other type 1 diabetes trials cannot serve as confirmatory evidence to satisfy the ‘substantial evidence’ standard, creating a potentially awkward situation for the agency when it comes to making an approval decision.
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Pink Sheet reporter and editors discuss whether emotion could be removed from US FDA advisory committees, adverse events and advancing science in gene therapy development, and Capitol Hill’s interest in the ongoing user fee negotiations.