This article was originally published in The Gray Sheet
Executive SummaryFDA is requiring data from a randomized clinical trial to be added to Imre's premarket approval application for its Prosorba immunoadsorption column for the treatment of cancer chemotherapy-associated thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (C-TTP/HUS), the firm announced on March 22. Imre says it has had discussions with FDA regarding an investigational device exemption protocol, which will also include an evaluation of Prosorba as a treatment for Classic TTP/HUS. Imre is ready to begin the trials as soon as FDA issues an IDE.
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