Replies to post #780 on Outlook Therapeutics Inc (OTLK)

[H2R]

The FDA SPA agreement is in!

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

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-receives-fda-agreement-under-special

Best of luck with your investments.