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Outlook Therapeutics® Submits Special Protocol Assessment (SPA) to FDA for Non-Inferiority Study of ONS-5010

Resubmission of ONS-5010 Biologics License Application (BLA) in the U.S. expected by the end of calendar year 2024 ISELIN, N.J., Dec. 19, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: ...
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Outlook Therapeutics Receives FDA Agreement for Three Special Protocol Assessments for Additional Planned Clinical Trials of ONS-5010

ONS-5010, an investigational ophthalmic formulation of bevacizumab for retinal indications, is currently in two clinical trials to treat wet age-related macular degeneration (wet AMD – NORSE 1 and 2).
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Outlook Therapeutics® Receives FDA Agreement Under Special Protocol Assessment (SPA) for 90 Day Non-Inferiority Study, NORSE EIGHT, and Announces Private Placement of Up to ...

Obtained clarity from U.S. Food and Drug Administration (FDA) on next steps to advance ONS-5010 NORSE EIGHT expected to commence in the first quarter of CY2024, enabling potential resubmission of the ...
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Outlook Therapeutics® Submits Special Protocol Assessment (SPA) to FDA for Non-Inferiority Study of ONS-5010

ISELIN, N.J., Dec. 19, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of ...