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The absence of serious adverse events across varied doses, administration routes, and treatment durations represents a key safety finding that distinguishes AOD-9604s clinical profile

Our proposed approach to use a single calendar quarter of data is most consistent with the Secretary's requirement under section 1847A(c)(5)(B) of the Act because the statute directs that Secretary to update quarterly a drug's ASP payment limit using manufacturer's ASP data from the most recent single calendar quarter for which such data are available, rather than several quarters

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Blood thinners do not actually thin the blood or dissolve existing clots, but they can prevent existing clots from worsening