Question · Q3 2024
Katherine Xu, on for Jon Wolleben, requested additional color on the FDA feedback for the paltusotine program in carcinoid syndrome and how the Phase III trial design might change relative to prior guidance.
Answer
Chief Medical and Development Officer Dr. Dana Pizzuti reported that the interaction with the FDA was very productive, with broad agreement. She noted the FDA provided perspective on endpoints and trial duration, which were anticipated and easily accommodated into the plan. The program remains on track with its previously stated timeline.
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