Foreign Data: Sintilimab’s Development Shows What Not To Do When Pursuing US Approval
The FDA’s concerns about conduct of ORIENT-11 trial include adequacy of informed consent, uncertainty about confidence in data generated in China, and failure of development partners Innovent and Eli Lilly to consult the US regulator about the study’s design.
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Start-up firm, with two Chinese-developed drugs for lung cancer in late-stage development, may be particularly vulnerable to the US Food and Drug Administration’s recently stated opposition to the Chinese-only research supporting Eli Lilly’s sintilimab.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.