D-Pharm Completes Pre-IND Meeting With The FDA For Treatment Of Acute Stroke With DP-b99
Mar 15th 2008Drug InformationStroke
D-Pharm announced that it has held its Pre-IND (Investigational New Drug) meeting with the FDA to discuss the forthcoming IND submission for DP-b99, a novel drug to aid recovery following acute stroke. The Pre-IND meeting focused on the proposed plans for the Phase III clinical program and the discussion included clinical trials to date, preclinical pharmacology, toxicology data and the FDA requirements and suggestions for the IND submission.
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