thermo
1週前
Europe seems to have value, particularly for a company with an established Euro salesforce. That's stating the obvious, I know. I believe there are a few partners that seems like good fits but, as everyone was focused on USA, the partnership opportunity hasn't been fully explored. Even now, the focus is on capital I would assume.
thermo
1週前
This month, we’ll see the 12 week data for Norse 8. It may look better than the pre-specified 8 week endpoint, or not…
If it does look better, the company will likely file the BLA and there’s a chance it gets approved. But it is impossible to have high conviction of a US approval, regardless of the data.
Which means the first problem is the capital necessary to get to a BLA decision. I see raising the necessary capital as very challenging. Institutions don’t like coin flips.
The company may either fail to raise the capital, leading to its closure, or secure funding under highly dilutive terms. Remember there is about $30M of debt outstanding, and terms will need to be amended.
The FDA has a problem too. If they decline to approve the LYTENAVA BLA, what happens to the 50% of the market that uses off-label Avastin now? If the FDA doesn’t believe LYTENAVA is safe and effective, how can they allow a similar (though inferior in several ways) product to remain in on the market? But, taking it off the market will cause significant disruption.
H2R
2週前
Resubmittal to the FDA
This is quite uncertain, given the current results of N.8. The Company says:
Previously, the Company reported that in the NORSE EIGHT trial, ONS-5010 did not meet the pre-specified non-inferiority endpoint at week 8 set forth in the special protocol assessment (SPA) with the U.S. Food and Drug Administration (FDA).
However, the preliminary data from the trial demonstrated an improvement in vision and the presence of biologic activity, as well as a continued favorable safety profile for ONS-5010. Analysis of the data is ongoing as the month 3 data from NORSE EIGHT is being collected, which is expected to be available in January 2025. Upon receipt of the full month 3 efficacy and safety results for NORSE EIGHT, Outlook Therapeutics plans to resubmit the BLA for ONS-5010 in the first quarter of calendar 2025.
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-reports-financial-results-fiscal-year-2024
Best of luck with your investments!
OGBritbox
3週前
So I’ve had a couple theories. In Norse 2 the patients were treatment naive, and so they would naturally show much better vision improvement. Is it possible FDA wanted Norse 8 to test with non treatment naive patients to see the difference in the drugs efficacy between the types of patients so Dr’s would have a better understanding of who to use what drug for ? Meaning, Dr’s and payors would all agree they can start new patients on ONS, but as they progress or have already started treatment, use something else for better results?
Another is that the trial was actually a stability test for the FDA to know how fast the drug loses potency, for expiration dates, as someone stated they heard Russ mention he was using older product they had for the trial.
Another is that once all data is processed it’ll show much better results, perhaps even meeting goals or close enough. Another is that it’s irrelevant, as a non inferiority trial only needs to show it’s not significantly worse than another drug, which it has and will show. We don’t know what the FDA’s margin is for that here, but if the other issues that caused the CRL have been resolved I believe it will be approved. The FDA knows it’s being used off label roughly 60% of the time for new patients already. So it works well enough, and the price is right, for Dr’s to start with. The FDA wants to replace it with a safer version that’s an approved. I believe the packaging and safety of the product is what’s the cornerstone issue for them here.
H2R
1月前
Russ Trenary is out!
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-executive-leadership-transition/
ISELIN, N.J., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year for LYTENAVA™ (bevacizumab gamma), the first ophthalmic formulation of bevacizumab authorized for the treatment of wet age-related macular degeneration (wet AMD) in adults, today announced that Russell Trenary has stepped down as the Company’s President and Chief Executive Officer (CEO), effective immediately. Lawrence Kenyon, Executive Vice President, Chief Financial Officer and member of the board of directors, has been appointed Interim CEO.
“On behalf of our management team and board, I would like to thank Russ for his dedication and many contributions to the Company and wish him the best in his future endeavors,” commented Randy Thurman, the Company’s Executive Chairman. “We are pleased to have Larry lead Outlook Therapeutics during this transition period. We remain committed to our plans to resubmit the BLA for ONS-5010 in the first quarter of calendar 2025 and to begin sales of LYTENAVA™ in Europe in the first half of calendar 2025.”
Mr. Kenyon has served as the Company’s Chief Financial Officer and Secretary since September 2015. He has been a member of Outlook Therapeutics’ board of directors since August 2018 and also served as the Company’s President and CEO from August 2018 to July 2021.
The Company has engaged an executive search firm to work with the board of directors to identify a permanent CEO.
I had completely missed that news. No wonder the PPS is not recovering. Two bad news in a row.
Ouch.
Best of luck with your investments!
H2R
1月前
And OTLK's PR
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-nice-recommendation-lytenavatm
“We are very pleased to receive the NICE recommendation of LYTENAVA™ (bevacizumab gamma) for patients with wet AMD. As the first positive reimbursement decision worldwide, this builds on our momentum and bolsters our commercialization strategy moving forward,” commented Jedd Comiskey, Senior Vice President, Head of Europe, of Outlook Therapeutics. “We remain committed to providing the UK health system with a cost effective treatment option for treating wet AMD. Looking ahead, our team continues preparations for commercial launch in the UK anticipated in 2025 and continues to work through the pricing and reimbursement processes for EU countries, with launches in the EU anticipated to follow.”
Best of luck with your investments!
H2R
1月前
Great find someconcerns Here is the NICE page
https://www.nice.org.uk/guidance/TA1022/chapter/1-Recommendations
Use the least expensive option of the available treatments (including bevacizumab gamma, aflibercept, faricimab and ranibizumab). Take account of administration costs, dosages, price per dose and commercial arrangements. If the least expensive option is unsuitable, people with the condition and their healthcare professional should discuss the advantages and disadvantages of other treatments.
Only continue bevacizumab gamma treatment if an adequate response is maintained. Criteria for stopping should include persistent deterioration in visual acuity and anatomical changes in the retina.
And yes, bevacizumab gamma is Lytenava / ONS-5010
Evidence-based recommendations on bevacizumab gamma (Lytenava) for treating wet age-related macular degeneration in adults.
Best of luck with your investments!
skuboo
1月前
Unfortunately guys, the story is almost over, the active ingredient is the same, dosage is twice as large, effectivness is less, why a doctor should prescribe less efficient drug? I hold position, will survive failure, it doesn't significantly matter if I sell now or wait for FDA possible rejecton due lack of effectivness compared to offlabel. Still waiting for OTLK disclosure of their financial strategy.
Best of luck for you
OGBritbox
1月前
The FDA and CMS know?Bevacizumab works. They've allowed off-label utilization of it, and reimbursed for off-label use, for years.
Compounded Avastin is essentially dead. The FDA went after Pine Pharmacy, which accounted for ~50% of the compounded Avastin. I wouldn't be surprised to see other compounding pharmacies exit the market so they don't experience a similar fate as Pine. CMS simply doesn't have the budget to replace every unit of compounded Avastin with Eylea, Lucentis, etc.
The trials goal was never to outperform the expensive specialty products in this space. It was to provide a safer formulation of Bevacizumab, so that patients can still receive an effective initial treatment before progressing to drugs that cost multiples of what we expect Lytenava to cost.
1. The FDA will evaluate both trials as a whole:
* NORSE TWO: Showed strong long-term efficacy (41% vs. 23% improvement in BCVA vs. Lucentis).
* NORSE EIGHT: Failed the non-inferiority endpoint at 8 weeks, raising short-term efficacy concerns.
Key Considerations:
1. Evidence: Long-term data (NORSE TWO) may outweigh short-term gaps.
2. Safety: Consistent safety profile supports approval.
3. Market Need: Cost-effectiveness could justify approval despite biosimilar competition.
The FDA has approved drugs under similar circumstances when there is an unmet need: Drugs addressing limited treatment options or offering cost-effective alternatives (e.g.,
LYTENAVA™ as an on-label alternative to Avastin).
1. Totality of Evidence: Approvals are based on combined trial results, where strong data from one study (e.g., NORSE TWO offsets weaker results from another (e.g., NORSE EIGHT).
2. Safety Profile: Consistent and acceptable safety records are key for consideration.
January will show full 3 month trial data that will be submitted to the FDA. I’m betting the data is better, and will be enough for approval. Either way, EU/UK sales will begin Q12025 making them cash flow positive. I told you a year ago to expect more fuckery. When you’re dealing with billions of dollars it gets shrewd. It wouldn’t surprise me one bit that they released the preliminary data before all was collected knowing it would shake most of the long holders out. Now she is primed for a buyout.
Still holding. We will know more in January.
H2R
1月前
Hi Thermo,
Investing in biotech is risky, and I think those who invest there are OK with risk. I am. On paper, today was not great. I hear arguments and read about companies, I invest based on the public information at hand. There are no guarantees with trials. I've been bitten a few times, and got some nice rewards other times.
Thanks for your input, I for one appreciate it.
Based on the previous Norse trials, I gave N8 a high likelihood of success. That's all it is though, a likelihood. I invested based on the UK/Europe approval, and also on the likelihood N8 would be reach its endpoint. Now the results are out. Also, this story is not over yet.
Anyways, I hope you keep on sharing your thoughts, on this ticker symbol or others.
Kind regards
Best of luck with your investments!
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