VILLA GUARDIA, Italy--(BUSINESS WIRE)--Gentium S.p.A. (NASDAQ: GENT) announced today that it plans to submit to the U.S. Food and Drug Administration (the “FDA”) an amendment to the protocol for its ongoing Phase III trial of Defibrotide for the treatment of hepatic veno-occlusive disease (“VOD”) with multi-organ failure. The decision to submit the amendment was prompted by recent discussions between the Company and the FDA.
