October 20, 2011 07:36 EDT Gentium provides update on MAA process for defibrotide in Europe
Gentium provided an update on the European Marketing Authorization Application for Defibrotide, the MAA, to treat and prevent hepatic veno-occlusive disease, VOD, in adults and children undergoing haematopoietic stem-cell transplantation therapy. The Company has received and reviewed the Day 120 List of Questions (LoQs) from the European Medicines Agency's (the "EMA") Committee for Medical Products for Human Use (the "CHMP") and anticipates that it will submit its responses by the end of December. (GENT)
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