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CellTrans’ Donislecel: Insulin Independence Data May Offer Path To Market In Type 1 Diabetes

Executive Summary

Proportion of subjects with freedom from exogenous insulin ‘might support the efficacy’ of the allogeneic islet cellular therapy, US FDA says after concluding that issues in two studies limit interpretability of primary analyses based on severe hypoglycemic events and HbA1c levels. An advisory committee will weigh clinical efficacy, safety and product characterization issues.

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