Outlook Therapeutics® Doses First Subject in NORSE EIGHT
Outlook Therapeutics expects NORSE EIGHT topline results and resubmission of the ONS-5010 BLA by the end of calendar year 2024.
- Outlook Therapeutics expects NORSE EIGHT topline results and resubmission of the ONS-5010 BLA by the end of calendar year 2024.
- The start of patient enrollment in NORSE EIGHT represents an important step toward potential FDA approval and launch of ONS-5010.
- Earlier this month, Outlook Therapeutics announced that it received written agreement from the FDA under an SPA for NORSE EIGHT.
- Outlook Therapeutics is working to address the open CMC items in the CRL and expects to resolve these comments prior to the expected completion of NORSE EIGHT.