Outlook Therapeutics Submits SPA For Required Study Of ONS-5010

(RTTNews) - 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. The FDA is anticipated to provide a response to the SPA in early February 2024.

Outlook Therapeutics plans to resubmit the ONS-5010 BLA by the end of calendar year 2024 to include the results of NORSE EIGHT and the additional CMC work to address the issues identified by FDA in the Complete Response Letter issued in August 2023.

"With the SPA now submitted, we are preparing to start NORSE EIGHT in the first quarter of 2024," said Russell Trenary, CEO of Outlook Therapeutics.

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