MGI/SuperGen Dacogen update
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
MGI and SuperGen have responded to a Sept. 1 "approvable" letter for Dacogen (decitabine), MGI says Nov. 15. The companies believe the response addresses FDA's questions regarding transfusion requirements in the Phase III trial for the myelodysplastic syndromes treatment and confirms that Dacogen met its primary endpoint...