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The significant increase in fissures observed in the PCPA-induced insomnia model group suggests that sleep disturbances may lead to notable changes in brain tissue morphology (Figures 8A,B)

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Accordingly, since it appears that REBYOTA TM and SER-109 are purposed to achieve the same therapeutic outcome using a similar mechanism of action and would be assigned to the same MS-DRG, we believe that these technologies may be ( substantially similar to each other such that they should be considered as a single application for purposes of new technology add-on payments, if SER-109 receives FDA approval by July 1, 2023