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Affymax, Inc. (AFFY) Message Board

  • dinepat203 dinepat203 Mar 8, 2013 1:10 PM Flag

    LONG can relax now Here is the TRUTH OF PROBLEM !!!

    Plus, in some cases, it's not the drug itself that contributes to the safety issue; it's the packaging. In the late 1990s and early 2000s, there was a marked increase in the number of cases of pure red-cell aplasia (PRCA) linked to Eprex, a version of epoetin alfa. Investigation revealed a connection between PRCA and the uncoated rubber stoppers in the drug vials. Analysts wondered if a similar manufacturing issue could be responsible for the postmarketing reactions to Omontys. Affymax said the clinical program had been run using drug from single-dose units, while the postmarketing program had used multidose vials. But that's only one piece of the company's overall investigation, Orwin said.

    "Clearly, among all the things we'll be investigating, we'll be looking very closely at drug products, in all its forms and at all stages of manufacturing, distribution, supply chain, handling at the sites," he said. "We'll look at every aspect of the product and the way it's been given."

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