Ferraprox Advisory Cmte: Can Risk Management Overcome Safety, Dosing Worries?
This article was originally published in The Pink Sheet Daily
Executive Summary
ApoPharma's transfusional iron overload treatment has been approved in Europe since 1999, but FDA sent a "complete response" letter in 2009.
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ApoPharma's risky move in not complying with FDA's request for an additional randomized controlled trial of its iron overload treatment Ferriprox (deferiprone) paid off in a lopsided advisory panel vote in favor of approval, but the agency has yet to give the final word.
ApoPharma's Ferriprox Gamble Pays Off In Panel Vote, But What About FDA?
ApoPharma's risky move in not complying with FDA's request for an additional randomized controlled trial of its iron overload treatment Ferriprox (deferiprone) paid off in a lopsided advisory panel vote in favor of approval, but the agency has yet to give the final word.