Diamyd Medical receives positive feedback from FDA on potential Accelerated Approval for Diamyd® in Type 1 Diabetes

Diamyd Medical received encouraging feedback from the U.S. Food and Drug Administration (FDA) regarding an Accelerated Approval pathway for its immunotherapy, Diamyd[®,] for treating patients with Stage 3 Type 1 Diabetes carrying the genotype HLA DR3-DQ2.In a recent in-person Type C Meeting the FDA acknowledged that C-peptide could be used by Diamyd Medical as a surrogate endpoint reasonably likely to predict the clinical benefit of preservation of endogenous insulin production. As such, Accelerated Approval could be sought based on a demonstration of significant treatment-related benefits