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Tuesday, March 29, 2016

OPKO Receives Complete Response Letter from FDA for RAYALDEE® New Drug Application

OPKO Receives Complete Response Letter from FDA for RAYALDEE® New Drug Application

  • Sole issue relates to third-party manufacturing observations
  • No new clinical studies requested
  • No safety or efficacy issues identified
  • Management to host conference call today at 8:30 a.m. Eastern time

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