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Curis, Inc. Message Board

forgetme22 1 post  |  Last Activity: Oct 13, 2014 8:06 PM Member since: May 6, 1998
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  • forgetme22 by forgetme22 Oct 13, 2014 8:06 PM Flag

    "In discussing a New Chemical Entity (NCE) designation, KERX cited Ferrlecit as a comparator, an IV iron ferric gluconate compound that was able to obtain NCE when there were already two ferric dextran IV iron formulations approved. Bentsur stated, “…the sponsor was able to prove to the FDA from an inorganic chemistry perspective that Ferrlecit’s physiochemical properties, mainly its high molecular weight complex structure, were critical for its improved activity as an IV iron formulation compared to the other IV iron compounds…If only ferric was the active moiety in our ferric citrate complex, how come no other oral ferric compound, or even more specifically ferric citrate compound, has ever demonstrated the phosphate binding or iron storage increases that we have?”

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