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Affymax, Inc. (AFFY) Message Board

  • longfellowsss longfellowsss Jun 16, 2014 1:04 AM Flag

    Is this a case of the story's the same

    only the drug name has changed?

    Did it really take 15 months of detailed investigations to find what concurrent drug monitoring would have shown. "no quality or manufacturing issues were present" That's it? Have they exonerated the dialysis centers? Did they bother to question people at the dialysis centers. I wonder if the investigations were as detailed as this report. What about those dna tests they were going to conduct with FMS does that fall under the "not identified a specific root cause".

    The other story involved Actos.
    "Central to the story is one Dr. Helen Ge, who worked for Takeda as a product reviewer. According to Dr. Ge, Takeda had been suppressing information about the effects of Actos upon heart patients, withholding this information in its reports to the FDA."

    Was it really a good idea to hand the investigation over to Takeda.
    That's right shorts drain so much value out of affy that it couldn't do the investigations itself.
    This is a big disappointment but not a total surprise to me.

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