Briefing documents posted Tuesday morning ahead of the FDA’s adcom discussing Amgen’s (AMGN) CodeBreaK200 confirmatory study flagged concerned for systemic bias and study conduct issues, Stifel tells investors in a research note, adding that the FDA is concerned that the PFS benefit is small and also flagged multiple potential biases that could have influenced the PFS result in favor of sotorasib. The firm says what’s bad for Amgen could be “good” for Mirati Therapeutics (MRTX), but specific physician commentary will be important to Mirati sentiment. Stifel made no change to its Buy rating on Mirati.
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