NeOnc Technologies to Meet FDA on NEO212 Clinical Program
What happened
NeOnc Technologies Holdings, Inc. announced it is scheduled to meet with the FDA on November 17, 2026, at the FDA’s White Oak campus. The meeting is an End-of-Phase 1 Type B discussion regarding the NEO212 clinical development program. The company plans to seek feedback on the trial design, patient population, and evidence needed to support a future marketing application.
From manilatimes.net
Why it matters
The meeting follows the completion of the Phase 1 dose-escalation portion of the NEO212-01 clinical trial. During Phase 1, dose escalation was discontinued following a dose-limiting toxicity at 810 mg, and 610 mg was selected as the recommended Phase 2 dose. The outcome of this discussion could influence the future regulatory path of the therapy.
From manilatimes.net
Who's involved
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The entities involved
- FDA
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White Oak
unincorporated area in Montgomery County, Maryland, United States, suburb of Washington, DC
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