Defibrotide regulatory update

Gentium plans to submit a response this quarter to Day 120 questions from EMA's CHMP related to the review of an MAA for defibrotide to treat and prevent hepatic veno-occlusive disease (VOD) in hematopoietic stem-cell transplantation therapy in adults and children. The MAA is under accelerated review by EMA which will shorten the review period to 150 from 210 days. The product has Orphan Drug designation in the EU and U.S. to treat and prevent VOD and Fast Track designation in the U.S. to treat VOD. ...