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Home » Consultant sees 'graveyard of companies FDA has killed'
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Consultant sees 'graveyard of companies FDA has killed'

July 25, 2011
By Mark McCarty
Edwards Lifesciences (Irvine, California) is in a peculiar state of affairs, having won over an advisory committee recommendation for its Sapien transcatheter aortic valve, but watching its shares lose 5% or more of their value in mid-day trading last Friday. The incidence of stroke was an issue during the hearing, but FDA is looking for two post-approval studies, one of which is sure to require a lot of additional money and time (Medical Device Daily, July 22, 2011). (Medical Device Daily)
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