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Professional dialysis recruitment| NephroGenex Reaches Agreement with the FDA on a Subpart H Phase 3 Program for ... - Sacramento Bee |
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Sacramento Bee In the Pyridorin™ Phase 3 Subpart H program, the FDA has agreed that approval will be based on a new surrogate endpoint that includes SCr changes after one year that predict progression to ESRD. These patients will subsequently be followed to confirm |
