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Keryx Biopharmaceuticals Inc. Message Board

  • hugochazev hugochazev Feb 9, 2013 5:22 PM Flag

    Caution is Warranted, Especially at $600M+ Market Cap


    "Since we are seeking approval for Zerenex under a SPA, based on protocol designs negotiated with the FDA, we may be subject to enhanced scrutiny. Regardless of the success of our Phase 3 clinical trial, a SPA does not guarantee approval. The FDA may raise issues of safety, study conduct, bias, deviation from the protocol, statistical power, patient completion rates, changes in scientific or medical parameters or internal inconsistencies in the data prior to making its final decision. The FDA may also seek the guidance of an outside advisory committee prior to making its final decision. Additionally, the regulatory approval of new therapies could invalidate our SPA, or require us to conduct additional, expensive clinical trials to obtain regulatory approval."

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