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FDA Asks ODAC To Consider Looser Parameters For PFS Analysis

This article was originally published in The Pink Sheet Daily

Executive Summary

At its July 24 meeting, FDA’s Oncologic Drugs Advisory Committee will be asked to discuss the pros and cons of conducting independent radiologic review of only a random sample of patient scans. Issues up for consideration include when blinded review of all patient scans is warranted and the level of discordance in progression assessments that would invalidate a study’s results.


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