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Rockwell Medical, Inc. Message Board

  • wspigener200 wspigener200 May 20, 2013 1:31 PM Flag

    Phase 3 endpoint?

    The phase 3 endpoint is to increase hemoglobin. Is there any previous trials that even show this? The prime endpoints are we're based on ESA not hemoglobin. I'm long for the run up but in trying to find out if I should hold through the data.

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    • Reading through the clinical trial information, the "phase 3 endpoint" is not necessarily to increase hemoglobin. Indeed, those who substantially fell outside the 9.5 -11.5 grams per deciliter range were to be excluded from the trial. As noted in the trial information, for inclusion, the mean Hgb was to be between 9.5 -11.5 grams per deciliter. I assume therefore that if a patient fell outside this range it was grounds for exclusion. I noted this point in another thread wherein SFP should not be viewed at as an "end all be all" treatment. If approved, the best case scenario is it will eliminate alternative intervention strategies in a vary small portion of patients. However, you should expect that the largest proportion of patients will benefit from a reduction rather than elimination of alternative intervention.


    • no the primary endpoint about hemoglobin was to see that it was MAINTAINED (at a normal level between 9.5 ad 11.5) which it was at 10.5. The main concern was to see how the ESA was affected by the treatment. It was found that it was 35% more effective when adjusting the data for changes in the hemoglobin (probably small normal random differences between a population)

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