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Affymax, Inc. Message Board

  • godwinpeak godwinpeak Feb 27, 2013 8:49 AM Flag

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    I read the article. Thanks. From my take, manufacturing is just one of the many avenues needed to determine why Omontys proved unsafe. No one has a clue, whether manufacturing or anything else, why Omontys proved fatal with an unacceptably high incidence of serious adverse incidents compared to Epogen. IMHO the first clue appeared in the "inexplicable" differences in the safety studies between the European PEARL studies (unacceptable levels of serious adverse reactions on nondialysis CDK patients) and the USA EMERALD studies (well within safety endpoints for dialysis CDK patients). It seems to me that Omontys should never have been approved in the first place.

 
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