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Story summary
- FDA declined in April to approve RP1, citing reliance on a study without a control group and requesting more data.
- Reviewers said trial design flaws make it hard to tell whether tumor shrinkage was due to RP1 and that response rates may be inflated.
- An advisory committee voted 10-3 for approval, with several members describing the data as “really messy.”
- The agency will decide on RP1’s accelerated-approval request by August 2.
