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Thursday, February 15, 2024 10:01:23 AM
We are proud of the recent progress our team has made. In January 2024, we received confirmation that the FDA has reviewed and agreed upon the NORSE EIGHT trial protocol pursuant to the SPA they approved. We also reached agreement that if the NORSE EIGHT trial is successful, it would satisfy the FDA’s requirement for a second adequate and well-controlled clinical trial to address fully the clinical deficiency identified in the CRL. Importantly, the first subject was enrolled in NORSE EIGHT in January 2024,” commented Russell Trenary, President and Chief Executive Officer. “In addition, through a Type A meeting and additional interactions, we have identified the approaches needed to resolve the CMC comments in the CRL. We are working to address the open items and expect to resolve these comments prior to the expected completion of NORSE EIGHT. Finally, we have entered into purchase agreements for a financing of up to $172 million, subject to shareholder approval, to support our regulatory efforts and launch preparations.
Best of luck with your investments!
![Bullish](/static/images/ih2-bull.png)
Recent OTLK News
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 06/14/2024 08:10:50 PM
- Outlook Therapeutics® to Present at the Virtual Investor Pitch Conference • GlobeNewswire Inc. • 06/11/2024 01:05:00 PM
- Outlook Therapeutics® Receives European Commission Marketing Authorization for LYTENAVA™ (bevacizumab gamma) for the Treatment of Wet AMD • GlobeNewswire Inc. • 05/28/2024 12:05:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/15/2024 09:19:05 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/15/2024 09:15:37 PM
- Outlook Therapeutics® Reports Financial Results for Second Quarter Fiscal Year 2024 and Provides Corporate Update • GlobeNewswire Inc. • 05/15/2024 09:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/13/2024 08:05:33 PM
- Outlook Therapeutics® Announces UK Submission of Marketing Authorization Application (MAA) for ONS-5010 as a Treatment for Wet AMD • GlobeNewswire Inc. • 05/13/2024 12:50:00 PM
- Outlook Therapeutics® to Report Financial Results for Second Quarter Fiscal Year 2024 on May 16, 2024 and Host Inaugural Quarterly Conference Call and Webcast • GlobeNewswire Inc. • 05/09/2024 12:45:00 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 05/07/2024 04:15:34 AM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 05/06/2024 08:09:46 PM
- Outlook Therapeutics® to Present at the Retina World Congress 2024 • GlobeNewswire Inc. • 05/02/2024 01:05:00 PM
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- Outlook Therapeutics® Announces Closing of Private Placement of $5.0 Million • GlobeNewswire Inc. • 04/15/2024 08:15:00 PM
- Outlook Therapeutics® Receives European Union Positive CHMP Opinion for ONS-5010 as a Treatment for Wet AMD • GlobeNewswire Inc. • 03/22/2024 11:35:35 AM
- Outlook Therapeutics® Announces Closing of Private Placement of up to $159 Million • GlobeNewswire Inc. • 03/18/2024 09:10:05 PM
- Outlook Therapeutics® Announces Effective Date for 1-for-20 Reverse Stock Split • GlobeNewswire Inc. • 03/12/2024 12:05:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/11/2024 08:43:10 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 09:30:50 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 09:18:39 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 09:11:11 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 09:08:43 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/07/2024 09:16:07 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 02/14/2024 10:10:29 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/14/2024 09:40:14 PM
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