NeOnc gets FDA written feedback backing NEO212 CMC plan, flags bioavailability study for tablet switch - NTHI News | RalliesNeOnc gets FDA written feedback backing NEO212 CMC plan, flags bioavailability study for tablet switch
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NTHI• FDA feedback supports NEO212 development plan
- NeOnc received FDA written feedback on CMC plans for NEO212, supporting continued development and setting conditions for late-stage work.
- The company canceled its July 9, 2026 Type B End-of-Phase 1 meeting after the FDA said written responses could serve as the official record.
- NeOnc is assessing timelines and costs, with an updated development plan expected following the review.
Tablet switch will require bioavailability study and CMC steps
- The FDA flagged an in vivo relative bioavailability study to support the planned switch from capsules to tablets.
- The agency outlined CMC steps needed before tablets enter a confirmatory phase, including final formulation and at least one GMP batch.
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