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With respect to the substantial similarity criteria, the applicant stated that SER-109 is not substantially similar to other currently available technologies because SER-109 does not have the same or similar mechanism of action as any currently FDA-approved CDI treatment and does not involve treatment of the same or similar type of disease or patient population as there are currently no approved therapies indicated to repair a disrupted microbiome as a treatment intervention to prevent recurrence in patients with rCDI

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