Gentium SpA (fka GENTY)

[surf1944]

7:31AM Gentium receives second list of outstanding issues from the EMA's CHMP for Defibrotide MAA (GENT) 10.55 : Co announced that it has received a second List of Outstanding Issues from the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use in connection with 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. The second LoOIs has reset the EMA's approval timetable back to Day 180. The Company plans to submit its response to the LoOIs within 60 days, in line with the new regulatory timetable. A recommendation on the approval of Defibrotide is now expected in early Q1 2013, based on the EMA review process timeline.