FDA Resubmission
Situation
- 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
Challenge
- 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
Resolution
- Starting with an FDA Complete Response Letter, Xelay Acumen supported an FDA resubmission with no new data