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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