FDA Resubmission


  • Client’s investigation drug was reviewed by the the FDA for approval
  • FDA responds with a formal Complete Response Letter (CRL) to client’s new drug suggesting an unclear risk/benefit of the drug


  • No new efficacy and safety data to reinforce investigation drug’s safety and efficacy
  • Existing communication to FDA unclear, encumbered by inconsistent data and trial design


  • Starting with an FDA Complete Response Letter, Xelay Acumen supported an FDA resubmission with no new data