Gentium S.p.A. (GENT) to Submit Response to LoQs from EMA Over Defibrotide MAA
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Gentium S.p.A. (Nasdaq: GENT) has provided an update on the European Marketing Authorization Application for Defibrotide (the "MAA") to treat and prevent hepatic veno-occlusive disease (VOD) in adults and children undergoing haematopoietic stem-cell transplantation therapy.
Following a clarification meeting recently held with the Company's Rapporteurs, Gentium anticipates submitting a response to the Day 120 List of Questions (LoQs) from the European Medicines Agency's (the "EMA") Committee for Medical Products for Human Use (the "CHMP") in the first quarter of 2012.
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Following a clarification meeting recently held with the Company's Rapporteurs, Gentium anticipates submitting a response to the Day 120 List of Questions (LoQs) from the European Medicines Agency's (the "EMA") Committee for Medical Products for Human Use (the "CHMP") in the first quarter of 2012.
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