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DewDiligence

04/04/17 6:59 PM

#210451 RE: jbog #210450

Re: MNTA /switching studies

The FDA draft guidance implicitly calls for at least three switches—the minimum number to generate two distinct exposures to both the branded drug and the FoB (#msg-127963701).

MNTA’s phase-3 trial for M934 (Humira FoB) anticipated and satisfies the above requirement, as far as I know (#msg-127945401).