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Rockwell Medical, Inc. Message Board

  • mkiss777777 mkiss777777 May 21, 2013 2:01 PM Flag

    Please get you facts straight

    The primary endpoint for the Phase III trial was met in the Phase 2b trial. The mean change in Hgb was .639 in the Phase 2B trial and it only needs to be greater than .5 in the Phase III trials to show effectiveness. There was a .177 drop in Hgb for the placebo side and a .462 gain in Hgb on the SFP side.
    The Phase 2B trial was very short so people in the placebo side did not use up their stored iron so the Hgb drop was small. Because of the Prime study data we can expect that data from the Phase III trials (being a much longer study than the Phase 2B trial) will show a much greater drop in Hgb on the placebo. Remember in the Prime study ESA’S had to be increased 35% to keep Hgb the same in the placebo group. Now in the Phase III trials ESA’s will be kept the same so the drop in Hgb should be much greater than the Phase 2B trial. Remember the phase 2B trial showed effectiveness and the phase III should be significantly better.

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