The FDA objects to biotech billionaire Bob Duggan’s PhIII plans — and he’s not budging
Summit Therapeutics, the Cambridge, MA-based biotech run by billionaire investor Bob Duggan, has found itself in the FDA’s crosshairs.
Last month, Summit announced its intent to combine two Phase III studies for its experimental C. difficile treatment, ridinilazole, into one trial in a process that involved changing the primary endpoint. But regulators do not agree with the new endpoint, the biotech revealed in an SEC filing Tuesday, raising questions about ridinilazole’s ongoing development.
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