Gentium SpA (fka GENTY)

[surf1944]

7:01AM Gentium provides update on the review of Defibrotide Marketing Authorization; co expects an opinion recommending against approval of the Marketing Authorization Application for Defibrotide (GENT) 11.93 : Co had presented an oral explanation at the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") as part of its Marketing Authorization Application ("MAA") for Defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy. Following the oral explanation, based on preliminary feedback from the EMA's CHMP, the co expects an opinion recommending against approval of the MAA for Defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy. While not a final decision, the Company considers it unlikely that this position will change before the formal vote is undertaken next month. If a formal negative recommendation is issued, and depending upon the nature of the objections, the Company may appeal such negative decision.