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Affymax, Inc. Message Board

  • godwinpeak godwinpeak Sep 17, 2013 3:21 PM Flag

    AFFY Longs Say Takeda/AFFY "Naturally Overreacted to Recall O. Cannot Understand Why.

    Those AFFY longs who like to post that the recall was "premature", an "overreaction" and "a bad business decision", are in strong denial of reality. Here are the facts:

    RW Baird analyst Christopher Raymond published in a research note, "[L]ooking at the FDA’s adverse event database for Epogen, Omontys appears to confer a 100-fold higher incidence of hypersensitivity and an 8.5-fold higher incidence of drug-related death (and that’s new).

    The Fresenius letter reported a .02% anaphylaxis "kill rate", and AFFY longs seem to say what is so bad about that. As reported in the NY Times, Dr. Daniel W. Coyne, a kidney specialist at Washington University in St. Louis, explains that “two in 10,000 deaths on first exposure is unacceptable, compared to nothing like this” with Epogen.

    But the problem with O's patient safety is much greater than the sanitized version Takeda/AFFY announced at the time of O's recall. While Fresenius mentioned 3 patient deaths caused by O, the WSJ reported 12 O patient deaths and 98 O serious adverse patient incidents.

    Howard Sklamberg, J.D., director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research, was blunt: "Due to the severity of the public health risk, we want to be certain that health care providers stop using Omontys."

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