Diamyd Medical to initiate its Type 1 diabetes Phase III trial in Europe as discussions continue with FDA regarding partial clinical hold in the US

The U.S. Food and Drug Administration (FDA) has requested additional data to support Diamyd Medical’s IND application for DIAGNODE-3, a Phase III trial with the diabetes vaccine Diamyd[®] in recent onset type 1 diabetes. Outstanding questions largely pertain to manufacturing of the study drug and need to be addressed before FDA’s partial clinical hold for the Phase III trial in the US can be lifted. Given the delay this may entail, Diamyd Medical will commence its initiation of the Phase III trial in Europe, while interactions with the FDA continue.To lift the partial clinical hold on