Gentium S.p.A. Responds to the EMA's Day 120 List of Questions for Defibrotide MAA
2/21/2012 9:50:54 AM
VILLA GUARDIA, Italy, Feb. 21, 2012 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT) (the "Company") announced today that it has submitted its response to the Day 120 List of Questions (the "LoQs") issued by the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") with respect to the Company's Marketing Authorization Application for Defibrotide to treat and prevent hepatic veno-occlusive disease (VOD) in adults and children undergoing haematopoietic stem cell transplantation therapy.
comments powered by