Gentium SpA (fka GENTY)

[surf1944]

6:01AM Gentium files documentation requesting a Re-examination of the negative opinion given by the EMA's CHMP regarding the MAA for Defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy (GENT) 8.30 : co announced that it has filed the documentation requesting a Re-examination of the negative opinion given by the European Medicines Agency's Committee for Medicinal Products for Human Use regarding the Marketing Authorisation for Defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy. In accordance with European regulations, the CHMP has 60 days to consider a revision of the initial opinion and consequently a final recommendation may be made by the end of July.