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Heartware International Inc. Message Board

  • greg_m_thornton greg_m_thornton Apr 25, 2012 7:24 PM Flag

    Wow a lot of negative comments from the panel

    Despite voting for approval, I was surprised by a lot of negative comments by the FDA panel. This may cause the FDA to reject this or at a minimum an expensive and rigorous post-approval study.

    Here are some of the negative comments:

    And panelist Dr Gregory Dehmer (Texas A&M University, Temple) said the trial's data "has more holes than Swiss cheese."

    But he (panel chair, Dr Richard L Page) slammed what he and others saw as a poorly conducted ADVANCE trial, calling its data "a mess."

    But others slammed the lack of a real, contemporaneous comparator group in ADVANCE and seemed ready to send the device-maker (also called HeartWare) back to get more direct comparative safety data. Dr John C Somberg (Rush University Medical Center, Lake Bluff, IL), said the admittedly small stroke rate in ADVANCE was still "worrisome" and "you can't judge safety" without a direct comparator group.

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