Upcoming Anticipated Milestones: Continued progress with ongoing pre-launch commercial preparations in anticipation of potential approval for ONS-5010 in 2023; PDUFA goal date of August 29, 2023; Completion of enrollment in the NORSE SEVEN clinical trial assessing the safety of ONS-5010 in a pre-filled syringe; and Estimated decision date from the EMA’s CHMP on the Company’s submitted MAA in EU for ONS-5010 expected in early 2024.
Published first on TheFly
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