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February 10, 2014
08:27 EDTMDCOFDA team leader recommends not approving cangrelor
Thomas A. Marciniak, M.D., a Medical Team Leader for the FDA, stated in briefing documents ahead of the February 12 panel meeting, "I recommend not approving cangrelor at this time for the PCI indication. I recommend not approving cangrelor until another trial succeeds in correcting the flaws that I have documented in this review and in my parallel review on the ethicalness of the cangrelor development program." Cangrelor is developed by The Medicines Co. and is an intravenously administered P2Y12 platelet inhibitor studied in three clinical outcomes trial in patients undergoing percutaneous coronary intervention. Shares of The Medicines Co. are down 12% to $29.99 after the documents were posted on the FDA's website. Reference Link
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