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Re: floblu14 post# 17094

Thursday, 04/13/2017 6:10:07 PM

Thursday, April 13, 2017 6:10:07 PM

Post# of 20689
The M923 phase-3 trial has already finished, for all practical purposes. The study met its primary endpoint, as announced in Nov 2016 (#msg-126858164), and it had the "switching" design that the FDA wants in order to award interchangeable status (#msg-127945401).

What remains of the trial is essentially tidying up loose ends in preparation for the 351(k) submission to the FDA that is expected to occur in mid 2017.

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