- Company management had a serious lapse of judgment in mis-designing their trials historically. They claim they were given informal support (not an SPA) from the FDA in 2018 but the 2023 FDA determined they did not provide adequate support for approval. They lost many people a lot of money including their biggest shareholder, who has a board presence. Another well-known board member bought significant stock in the open market above $1.00. So, clearly the people best positioned to judge, misjudged. It happens.
- I discussed this trial design concern with them historically and I accepted their explanation about feedback they received in 2018. That was a serious lapse of judgement on my part. Most retail investors would be surprised to know how often professional investors make mistakes. I've made lots of mistakes yet have become quite well off. We don't have perfect foresight, but we do know how to manage risk.
- The company now has an SPA, so the odds of approval are high. There's never been much debate regarding the efficacy and safety of the drug.
- Shortly, the debate will shift to what market share the company will achieve upon commercial launch. Longer lasting treatments are better, but insurance companies still utilize step-edit programs to hold down claim costs. These longer lasting treatments could push down pricing of biosimilars, which could pressure OTLK. Can I precisely predict all these effects? No. But I know what to look for and I know that OTLK doesn't need too much share of the total market to achieve meaningful revenue.
- After the recent raise, there are a lot of shares outstanding. About 750M. If you look up the share count from various sources, you'll see a much lower number but those are lagging. We go through the existing placement agreement and the note amendment and model out what the future share count will likely be.
- To forecast stock returns, we forecast peak returns, multiply by not too high a multiple (since this is a one -- not first in line -- product company), and then divide by 750M - 850M shares. This value is a lot lower than it used to be (due to the share count) but still a lot higher than it is now.
- So, even though I 've lost a good amount of money, I'm probably going to make a good amount of money before the fat lady sings. Unless, of course, she falls on me first.
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
- Outlook Therapeutics® to Present at the Ophthalmology Innovation Summit (OIS) Retina Innovation Showcase • GlobeNewswire Inc. • 04/29/2024 01:00:00 PM
- 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
FEATURED BNCM and DELEX Healthcare Group Announce Strategic Merger to Drive Expansion and Growth • Jul 2, 2024 7:19 AM
EWRC's 21 Moves Gaming Studios Moves to SONY Pictures Studios and Green Lights Development of a Third Upcoming Game • EWRC • Jul 2, 2024 8:00 AM
NUBURU Announces Upcoming TV Interview Featuring CEO Brian Knaley on Fox Business, Bloomberg TV, and Newsmax TV as Sponsored Programming • BURU • Jul 1, 2024 1:57 PM
Mass Megawatts Announces $220,500 Debt Cancellation Agreement to Improve Financing and Sales of a New Product to be Announced on July 11 • MMMW • Jun 28, 2024 7:30 AM
VAYK Exited Caribbean Investments for $320,000 Profit • VAYK • Jun 27, 2024 9:00 AM
North Bay Resources Announces Successful Flotation Cell Test at Bishop Gold Mill, Inyo County, California • NBRI • Jun 27, 2024 9:00 AM