Discovery / Non-clinical

End of Phase-2 meeting

European client entering a pivotal program in a competitive market

  • EU based company developing a gastrointestinal product in a competitive and controversial market (opioids)
  • The company intends to pursue adaptive Phase 2/3 clinical program to expedite late-stage development
  • Company intent to gain agreement from FDA on completion of nonclinical and CMC (quality) program to support marketing approval

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Authorization / Approval

Type C Meeting

US Company developing a patient-reported outcome (PRO) as the primary endpoint for the Phase 3 program

  • Under guidance from FDA, the company performed multiple Phase 1 and 2 studies to support validation of PRO efficacy measuring tool
  • Company intent to gain agreement on validation of PRO for use in Phase 3 studies to support small molecule development for celiac disease

Posted:

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