For the accelerated approval crowd: "The guidance cautions that many serious diseases with unmet need have available biomarkers lacking the necessary evidence to support a conclusion on reasonably likely to predict clinical benefit." insights.citeline.com/pink-sheet/p... - ThreadSky | a Reddit-style client for Bluesky

sarahkarlin-smith.bsky.social • 79 days ago

For the accelerated approval crowd: "The guidance cautions that many serious diseases with unmet need have available biomarkers lacking the necessary evidence to support a conclusion on reasonably likely to predict clinical benefit."
https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/accelerated-approval-us-fda-explains-reasonably-likely-determination-criteria-YRA3ICLQ3FALDO23KK3HH27SUY/

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