FDA Provides Written Feedback on NEO212 CMC Development and Capsule-to-Tablet Transition
“The FDA’s written feedback is detailed, constructive and actionable,” said Amir Heshmatpour, Chief Executive Officer, Executive Chairman and President of NeOnc. “It provides greater clarity regarding the manufacturing, formulation and bioavailability work required to support the transition of NEO212 from the current capsule formulation to a tablet intended for late-stage clinical development. We are now integrating these requirements into a disciplined development plan and will continue working with the FDA as the program advances.”
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