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Posted On: 11/05/2024 6:59:00 AM
Post# of 153501
Quote:
Surrogate reads like anecdotal is back in play.
In FDA's mind, surrogate is most certainly not anecdotal. Biomarkers need to be validated. In oncology, overall/objective response rate (ORR) is an established surrogate endpoint with duration of response (DOR) supporting.
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