I keep being impressed with management clarity on planning, deadlines, and execution!
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 $172 Million to Advance ONS-501
* 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 ONS-5010 Biologics License Application (BLA) by the end of CY2024
* Private placements to top tier institutional investors and insiders include up to $65 million in common stock and up to an additional $107 million upon cash exercise of warrants, subject to closing conditions
*Aggregate financing, subject to achievement of milestones, is expected to be sufficient to take ONS-5010 through potential FDA approval and fund commercial launch