NeOnc receives FDA written feedback on NEO212 CMC development; cancels Type B meeting

NEONC TECHNOLOGIES HOLDINGS, INC.

FDA provided detailed CMC feedback for NEO212, a temozolomide-perillyl alcohol conjugate for CNS cancers.
FDA stated NeOnc's CMC approach appears reasonable; additional comparative assessments may be needed if process changes.
FDA allowed parallel CMC development with late-stage clinical program, subject to supporting data.
FDA requires an in vivo relative bioavailability study to support capsule-to-tablet transition.
NeOnc canceled the July 9 Type B End-of-Phase 1 meeting after determining written responses were sufficiently clear.

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