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FDA staff divided over Medicines Company's Cangrelor

  • It seems that FDA staff are divided over Medicines Company's (MDCO) Cangrelor drug for preventing blood clots.
  • As noted, one review has recommended that the drug should not be approved due to trial flaws.
  • However, ISI Group analyst Umer Raffat has pointed out that buried deep in an FDA briefing document, another review has recommended approval of Cangrelor (see page 11 of the document).
  • Shares were down 13% earlier but have recovered somewhat and are -5.8%.
  • Given the sensitive nature of these reviews for the market, surely the FDA should have given equal billing to a summary of both opinions at the beginning of the briefing document.
  • The FDA's recommendations come ahead of a meeting of an advisory committee that is due to take place on Wednesday.
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