After Lilly's sintilimab shellacking, China-only oncology trials are facing a new — and unfavorable — reality at the FDA
As expected, Eli Lilly and Chinese partner Innovent faced a firing line at yesterday’s ODAC, forced to respond to a seemingly never-ending list of issues with their application for PD-1 drug sintilimab. That will likely set up an unfavorable decision from the FDA and tarnish sintilimab’s chances moving forward.
But what does yesterday’s opinion mean for the future of China-only trials looking to crack the US market? According to analysts, the outlook doesn’t look good.
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