Gentium S.p.A. Provides Update on MAA Process for Defibrotide in Europe
10/20/2011 10:37:48 AM
VILLA GUARDIA, Italy, Oct. 20, 2011 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT) (the "Company") today 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.