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FDA’s Cangrelor “Complete Response” Leaves Room For Approval Without New Trial

This article was originally published in The Pink Sheet Daily

Executive Summary

Agency requests additional analyses, but not a new study, supporting the antiplatelet’s use in patients undergoing percutaneous coronary intervention, The Medicines Co. says. However, a second indication in stent thrombosis patients who must stop oral antiplatelet therapy would require a new outcomes trial.

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