Transplant Therapeutics Consortium Receives FDA Acceptance of the Qualification Plan for iBox Scoring System [Yahoo! Finance]
Bristol-Myers Squibb Company (BMY)
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Source: Yahoo! Finance
Nov. 20, 2024 /PRNewswire/ -- The American Society of Transplant Surgeons (ASTS) and American Society of Transplantation (AST) announced today that the Transplant Therapeutics Consortium (TTC) received notification from FDA of acceptance of the Qualification Plan for the iBox Scoring System, a novel reasonably likely surrogate efficacy endpoint for kidney transplant clinical trials. This takes us one step closer to having new therapies that better the lives of transplant recipients and marks the successful completion of step two in the three-step process for FDA biomarker qualification. The iBox scoring system is the first transplant endpoint to reach this stage of qualification. "With the iBox Scoring System on the pathway to FDA qualification, we are closer than ever to cutting-edge clinical tools that could extend the lives of transplant recipients. iBox is opening the door to using artificial intelligence and machine learning. This achievement signals a transformative shift in h
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