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H2R

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H2R

Re: None

Thursday, 12/29/2022 12:39:16 PM

Thursday, December 29, 2022 12:39:16 PM

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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; and

Estimated decision date from the EMA’s Committee for Medicinal Products for Human Use (CHMP) on the Company’s submitted MAA in EU for ONS-5010 expected in early 2024.
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