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Affymax, Inc. Message Board

  • tpmavrakos tpmavrakos Mar 1, 2013 7:08 AM Flag

    good article from seeking alpha.omontys is better than epogen.only .02 percent reaction

    That's good

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    • What seeking alpha and all of the others encouraging long speculation in AFFY fail to mention is that there is a cogent argument to be made that Omontys should never have received FDA approval in the first place. All of those analysts fail to mention, when they ought to emphasize, the disastrous results of the PEARL studies for Omontys. AFFY's European based PEARL study showed that when Omontys was administered to chronic kidney disease (CKD) patients not on dialysis, there were statistically significant greater numbers of serious adverse reactions compared to Epogen. Astonishingly, the USA based EMERALD study showed that when Omontys was administered to CKD patients on dialysis (these are usually the sicker CKD patients), the numbers of serious adverse reactions were well within the safety profile for Epogen. One AFFY medical reviewer said the safety profile for Omontys established by the PEARL studies was so bad, that he called it "suicide" for AFFY to ask the FDA approval for Omontys to be used generally for CKD patients. AFFY said that the differences between the two safety profiles were "inexplicable" "had no definitive answer" and was something to bear in mind during its pilot program with dialysis CKD patients. AFFY will have some explaining to do with the FDA.

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