NEONC TECHNOLOGIES HOLDINGS, INC. — Form 8-K

NeOnc received written FDA feedback on NEO212 chemistry, manufacturing, and controls (CMC) development, with the FDA stating the company's CMC approach appears reasonable and that drug-product development may proceed in parallel with clinical programs. The FDA required a relative bioavailability study for capsule-to-tablet formulation transition and specified GMP batch manufacturing, formulation finalization, and dissolution method development before confirmatory clinical trials. NeOnc canceled a scheduled July 9 Type B End-of-Phase 1 meeting, determining the written responses sufficiently addressed questions.