FDA pauses start of DIAGNODE-3 in the US pending clarification on study drug
The start of the Phase III trial DIAGNODE-3 in the United States is being paused by the US Food and Drug Administration (FDA) to clarify certain outstanding questions regarding the study drug. Diamyd Medical will be notified of which questions that are outstanding within 30 days.A so-called "partial clinical hold" means that the FDA has not yet approved all parts of a study submission. The FDA has informed that it does not yet have sufficient information on questions concerning the study drug. The FDA will within 30 days provide more details on what information needs to be supplemented in