Gentium S.p.A. Submits Day 180 Response to List of Outstanding Issues Received From the EMA's CHMP for Defibrotide MAA
Published: Jun 21, 2012
VILLA GUARDIA, Italy, June 21, 2012 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT) (the "Company") announced today that it has submitted its responses to the Day 180 List of Outstanding Issues (the "LoOIs") received from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) with respect to the Company's Marketing Authorization Application (MAA) for Defibrotide to treat and prevent hepatic veno-occlusive disease (VOD) in adults and children undergoing haematopoietic stem cell transplantation therapy. Gentium expects to receive an opinion from the CHMP regarding the approval of Defibrotide during the third quarter of 2012.