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H2R

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Alias Born 07/17/2014

H2R

Re: None

Saturday, 12/30/2023 1:21:01 PM

Saturday, December 30, 2023 1:21:01 PM

Post# of 948
2024 OTLK Anticipated Milestones


FDA response on NORSE EIGHT Special Protocol Assessment (SPA) 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.



https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-reports-financial-results-fiscal-year-2023

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