Gentium SpA (fka GENTY)

[surf1944]

7:31AM Gentium submits day 180 response to list of outstanding issues received from the EMA's CHMP for Defibrotide MAA (GENT) 9.40 : Co announced that it has submitted its responses to the Day 180 List of Outstanding Issues received from the European Medicines Agency's Committee for Medicinal Products for Human Use with respect to the Company's Marketing Authorization Application for Defibrotide to treat and prevent hepatic veno-occlusive disease 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. If the written responses satisfy the questions raised in the LoOIs and the CHMP does not require any further explanation or clarification, a recommendation regarding the approval of Defibrotide could be issued by the CHMP as early as the third quarter of 2012.