Gentium SpA (fka GENTY)

[surf1944]

7:32AM Gentium announces MAA for defibrotide accepted by EMA and will be reviewed by CHMP under accelerated assessment (GENT) 9.98 : Co announces that its Marketing Authorization Application seeking approval of Defibrotide for the prevention and treatment of hepatic veno-occlusive disease following stem-cell transplantation has been accepted for review by the European Medicines Agency. Acceptance of the MAA indicates that the application is complete and initiates the regulatory review process by the Committee for Medicinal Products for Human Use. CHMP has agreed to the co's request for an accelerated assessment of the MAA. Under accelerated assessment, the review timeline of the MAA is shortened from 210 to 150 days.