NeOnc receives FDA CMC feedback on NEO212; capsule-to-tablet bioavailability study advised

NeOnc received detailed FDA written feedback on CMC development for NEO212 and guidance on capsule-to-tablet transition.

Key Highlights:

• FDA provided written CMC feedback that NeOnc’s proposed development approach appears reasonable.
• FDA advised additional comparative assessments if drug-substance process or physical characteristics change.
• Company may proceed drug-product development in parallel with late-stage clinical program with supporting data.
• FDA recommended an in vivo relative bioavailability study to support transition from capsule to tablet.
• FDA identified CMC tasks before confirmatory trials: finalize tablet formulation, GMP batch, controls, characterization, dissolution method.

Original SEC Filing:

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