Gentium SpA (fka GENTY)

[surf1944]

7:34AM Gentium provides update on MAA for Defibrotide (GENT) 6.32 : Co provided an update on the European Marketing Authorization Application for Defibrotide to treat and prevent hepatic veno-occlusive disease (VOD) in adults and children undergoing haematopoietic stem-cell transplantation therapy. The co has received and reviewed the Day 120 List of Questions from the European Medicines Agency's Committee for Medical Products for Human Use and anticipates that it will submit its responses by the end of December. Gentium submitted the MAA for Defibrotide to the EMA in May 2011 and the CHMP issued the LoQs at the end of September 2011, following the initial accelerated review of the Defibrotide registration dossier. Gentium has informed the CHMP that it intends to submit responses before year-end, within the EMA's standard three month response time frame for LoQs. The CHMP review of the MAA will resume with Day 121 upon submission of Gentium's response. Following this review period, Gentium expects to respond to any further questions during the first quarter of 2012, at which point the timeline to finalize the process will be made clearer.