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Changing horses midstream

In 2005, based on discussions with FDA, Gentium S.p.A. designed a Phase III trial of defibrotide to treat veno-occlusive disease with overall survival as the primary endpoint. Last week, the company said it plans to submit a protocol amendment to change the endpoint of the ongoing trial to complete response rate - again based on advice from the agency.

According to GENT, FDA believes this endpoint will make it easier to discern a treatment effect in

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