After the re-submission
( https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-re-submits-biologics-license-application)
the ball is in the camp of the FDA.
Russ mentioned an end of October response from the FDA in his interview (thanks for the link pfelgueiras!!). That would make sense. OTLK does not control how the FDA proceeds of course, so it's different from other timelines OTLK provided and met.
I expect the FDA to provide a PDUFA date. Then we have a target for approval/launch. a BO could happen anytime as well. There are incentives
( https://investorshub.advfn.com/boards/read_msg.aspx?message_id=167601827 and
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=167601089)
but even if they go it alone, this should be a great ride.
The MC is only $286.95M. If all does fall into place, the MC would end up in multiples (pick your own crystal ball prediction, mine is 10x)
Best of luck with your investments!
Recent OTLK News
- Form SC 13D/A - General statement of acquisition of beneficial ownership: [Amend] • Edgar (US Regulatory) • 11/29/2023 09:01:15 PM
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- Outlook Therapeutics® Announces Receipt of Type A Meeting Minutes and Reiterates Regulatory Path Forward for ONS-5010 • GlobeNewswire Inc. • 11/27/2023 01:05:00 PM
- The Gross Law Firm Notifies Shareholders of Outlook Therapeutics, Inc. of a Class Action Lawsuit and a Lead Plaintiff Deadline of January 2, 2024 - (NASDAQ: OTLK) • PR Newswire (US) • 11/21/2023 10:45:00 AM
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- The Gross Law Firm Notifies Shareholders of Outlook Therapeutics, Inc. of a Class Action Lawsuit and a Lead Plaintiff Deadline of January 2, 2024 - (NASDAQ: OTLK) • PR Newswire (US) • 11/14/2023 10:45:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/02/2023 12:12:40 PM
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- Form 8-K - Current report • Edgar (US Regulatory) • 10/20/2023 09:00:27 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/05/2023 09:15:43 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/05/2023 09:14:47 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/05/2023 09:07:18 PM
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- Outlook Therapeutics® Requests Type A Meeting With FDA • GlobeNewswire Inc. • 09/29/2023 12:05:00 PM
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- Form 8-K - Current report • Edgar (US Regulatory) • 08/30/2023 10:21:01 AM
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- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 08/28/2023 04:15:11 AM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 08/25/2023 08:31:39 PM
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- Form 8-K - Current report • Edgar (US Regulatory) • 08/14/2023 08:15:30 PM
- Outlook Therapeutics® Reports Financial Results for Third Quarter Fiscal Year 2023 and Reiterates Key Anticipated Near-Term Milestones • GlobeNewswire Inc. • 08/14/2023 12:05:00 PM
- Outlook Therapeutics® to Present at the BTIG Virtual Biotechnology Conference 2023 • GlobeNewswire Inc. • 08/01/2023 12:45:00 PM
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