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Affymax, Inc. Message Board

  • foggiafc foggiafc Jun 30, 2013 10:11 PM Flag

    Looks like CHMP had concerns about the adverse reactions in the U.S.

    Reading through the EMA website, CHMP had submitted some questions. Takeda withdrew the app because it stated it could not address those concerns within the given timetable. looks like, because of the adverse reactions CHMP were not going to approve O, which in my opinion is understandable until the investigations were completed. Looks like this could be a long haul, not what I was hoping. There is also something CHMP said that gives of great concern." The Committee was also concerned by the results of inspections indicating that the study data submitted might not be fully reliable". The other stuff did not concern me but that sentence has me worried.

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    • Why worry now foggi. For months I have pointed out that O's clinical trial results were nonsensical. How can the PEARL studies prove O to be was unsafe for the healthier CKD patients not on dialysis and, at the same time, the EMERALS studies prove O to be safe for the sicker CKD patients on dialyysis? Intuitively it did not make sense. AFFY could not explain it. AFFY called the discrepancy in safety profiles between the EMERALD and PEARL studies "inexplicable" and "one for which there is no definitive answer." It ought to cause the FDA concern now that O is a proven killer of patients, just as it causes concern at the CHMP. How does Takeda explain the "inexplicable"?

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