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Affymax, Inc. Message Board

  • machinious machinious Feb 25, 2013 8:30 PM Flag

    What REALLY happened here....

    I’d like to preface my comments by disclosing that I’m longer than a horse here. That said and all biases aside:

    For those of you who assumed that the opportunity/binary play was related to Fresenius and “will they or won’t they,” and that the worst case was a $10 pps if the latter came to fruition, your head must be spinning today. The truth is that the announcement of 19 anaphylactic events and 3 related deaths was unrelated to Fresenius’ evaluation. It was a meteor, a bolt of lightening or choose your analogy.

    Having said that, what happened? What we know:

    1) Omontys has been administered to some 27,000 patients (clinical trials and on the market once approved).
    2) Omontys was administered for more than 2.5 years (again, between clinical trials and once approved and sold).
    3) During those 2.5+ years, there were no such reports of extreme allergic reactions.
    4) Fresenius, in their internal memo last week, which was made public, stated that Omontys was “well tolerated” in a patient population of 18,000 and that allergic reactions were infrequent and that severe allergic reactions were almost non-existent.
    5) Suddenly, in February and after 32 months of no such incidents, 3 deaths occurred which were attributable to Omontys.

    So, the question becomes; what happened in February that caused these sudden adverse reactions, which were not consistent with the previous 32 months? Because the deaths occurred in a short span of time, this would certainly suggest that the deaths are likely attributable to so certain circumstances that came about recently.

    Possibilities?

    1) Introduction of Omontys to new centers without proper training for the administrators.
    2) Supply chain issues/delays, which may have compromised a few lots of product.
    3) Contamination associated with certain lots of product.
    4) In symbolic observance of black history month; excessive consumption of Hennessey among Affymax minority manufacturing personnel resulting in carelessness and subsequent contamination of product.

    The FDA has launched an investigation, but the truth is that we may not learn the root cause. That said; consider the statistical probability of 3 deaths in 3 weeks when zero deaths had been observed in the previous 32 months. Coincidence?

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