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The FDA Approval Timeline: A Realistic Outlook Projecting FDA approval dates involves several variables that are partially opaque to outside observers, including trial completion dates, data lock, NDA submission timing, and the FDA's review clock

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In addition, we paid close attention to the delivery process, including the number of delivery updates the company provided and the quality of the packaging

As the first round of MFP implementation data becomes available in 2026, the re-pricing of small-molecule commercial assets is likely to become more visible and more rapid