FDA response on NORSE EIGHT Special Protocol Assessment in early February 2024; Commencement of NORSE EIGHT expected in first calendar quarter of 2024; MAA decision date in the EU for ONS-5010 expected targeted for first half of 2024; Completion of NORSE EIGHT in the U.S. anticipated in 2024; and Resubmission of the ONS-5010 BLA expected by the end of calendar year 2024.
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