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The elimination half-life ranged from 2.4 to 3.1 hours for the three lowest doses and 6.4 and 5.5 hours for dose levels 4 and 5

With respect to the newness criterion, the applicant stated that REBYOTA TM received BLA approval from FDA on November 30, 2022 for the prevention of rCDI in individuals 18 years of age and older, following antibiotic treatment for rCDI

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