Published in Medical Letter on the CDC and FDA, February 10th, 2008
EpiCept announced that its Marketing Authorization Application (MAA) seeking marketing approval for Ceplene in the European Union has advanced to the next important step. The Company has submitted full written responses to the Day 180 List of Outstanding Issues to the Committee for Human Medicinal Products (CHMP). With this response, EpiCept believes it has now addressed all outstanding issues related to the MAA.
The next regulatory milestone for Ceplene will be...
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