Gentium SpA (fka GENTY)

[surf1944]

7:35AM Gentium responds to the EMA's Day 120 List of Questions for Defibrotide MAA; says ' we have finalized and submitted written responses to the LoQs' (GENT) 8.58 : Co announced that it has submitted its response to the Day 120 List of Questions 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. "Following the submission of the Day 120 LoQs responses, the CHMP will continue its review of the MAA and will either issue an opinion on the MAA or submit a List of Outstanding Issues (LoOIs) requiring further clarification, the latter of which will stop the review clock to permit the Company time to respond. The CHMP is expected to reach its final opinion no later than day 210 calculated based on the EMA review process timeline."