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Considering our ratesetting methodology and prior experiences implementing new data, we issued a follow-up from the CY 2023 PFS comment solicitation for general information

Study 1 The safety, efficacy, and PK of ADYNOVATE were evaluated in a multicenter, open-label, prospective, non-randomized, two-arm clinical trial (Study 261201, NCT01736475) that compared the efficacy of a twice weekly prophylactic treatment regimen to on-demand treatment and determined hemostatic efficacy in the treatment of bleeding episodes

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