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Amylin Pharmaceuticals, Inc. Message Board

  • kevinmik kevinmik Feb 24, 2010 9:42 AM Flag

    The FDA's Credibility Will Be Closely Watched On March 5th..

    The agency has left no safety stones unturned over the past 6 years trying to document factual proof in clinical trials and during post marketing that Exenatide is associated with causing major safety problems and they have come up completely empty handed. The only real side effect problems surrounding Exenatide that have any validity are minor annoyances like nausea and some vomiting and even those issues are seen less often with EQW. Bottom line based on everything that is known about Exenatide's safety and efficacy profiles and that is a lot of well documented, factual information, the FDA has absolutely no grounds to reject, delay or issue anything other than an approval for EQW on March 5th. The BENEFIT vs risk profile of EQW mandates that a timely approval for EQW be given on March 5th and should the FDA choose to do anything other then issue an approval on March 5th, the agency will need to be confronted about its decision and the politics behind it. The one overriding problem that would justify a slight delay past the March 5th date is if manufacturing issues are still outstanding. We will all know for sure on March 5th whether the FDA places greater value on introducing life savings drugs to the public or if their political ties are more important.

    Amylin Long
    Kevinmik

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