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Outlook Therapeutics® Reports Financial Results for Fiscal Year 2023 and Reiterates ONS-5010 Clinical and Regulatory Path Forward in the U S and EU

Commencement of ONS-5010 NORSE EIGHT clinical trial targeted for first calendar quarter of 2024Company reaffirms potential for European approval for ONS-5010 with Marketing Authorization Application .

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

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

Outlook Therapeutics® Submits Special Protocol Assessment (SPA) to FDA for Non-Inferiority Study of ONS-5010
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United statesUnited kingdomRussell trenaryJenene thomasOutlook therapeutics incExchange commissionDrug administrationSubmits special protocol assessmentNon inferiority studyLicense applicationOutlook therapeuticsSpecial protocol assessmentComplete response letterChief executive officerOutlook therapeuticAnnual report

Outlook Therapeutics Submits SPA For Required Study Of ONS-5010

Outlook Therapeutics, Inc. (OTLK) said, following receipt of written confirmation of the NORSE EIGHT proposed clinical trial protocol with the FDA, the company has submitted a Special Protocol Assessment request for the required additional adequate and well-controlled study of ONS-5010.

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

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