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( We agree with the applicant that the LimFlow System meets the cost criterion and are therefore proposing to approve the LimFlow System for new technology add-on payments for FY 2024, subject to the technology receiving FDA marketing authorization as a Breakthrough Device for the indication corresponding to the Breakthrough Device designation by July 1, 2023

Inoue and Oishi, 2005

For a contrasting case in which a peptide with a defined endogenous role and a more constrained but still incomplete mechanistic literature has nonetheless attracted sustained research interest, see the epitalon research brief

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