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OTLK Launch Map
I like geographical maps with pretty colors. This one looks realistic; They've had the European approval in May 2024 and the UK approval in July 2024.
In August 2024, OTLK must have a pretty good view on the launch in those two countries and are executing on the plan. Given their track record, I believe the launch dates in different counties will be close if not exactly as shown here.
Best of luck with your investments!
Revised Timeline for Norse 8
I had been wondering about the enrollment completion and the date on the estimated primary completion date on the clinical trial site. (see previous post).
The August 2024 OTLK presentation has a revised time line:
See: https://ir.outlooktherapeutics.com/events-and-presentations/presentations
which matches better with the current status (Active recruiting) of Norse 8. The topline data is now expected in Q4 2024 and the submittal to the FDA will not be done this year; it is now planned for Q1 2025. That makes more sense. Approval in 2025 is realistic. And in the meantime, European sales will start Q1 2025 with Germany and the UK.
Bullish OTLK. Best of luck with your investments!
Carmel, IN, site added: 61 sites
From today's update on Clinical Trials, this new trial site was added
* Carmel, Indiana, United States, 46290
I would have been happier if this site had been added one month ago. I am now wondering when the study will actually complete. Since the protocol requires a 3 months treatment, the current planned primary completion date of 'Sept 2024' seems off. That date was not changed with the update to Clinical Trials.
Still bullish.
Best of luck with your investments!
Short Seller Misinformation
https://ih.advfn.com/stock-market/NYSE/nuscale-power-SMR/stock-news/94270860/nuscale-power-comments-on-short-seller-report
Hurts the stock, but no penalty for Hunterbrook.
"Hunterbrook is a known short-seller that has a vested interest in sensationalizing information to manipulate the stock market. The Securities and Exchange Commission has not communicated to NuScale that it is the target of a current or prospective investigation, and the Company is unaware of any reason for such an investigation."
un bémol:
The primary completion is estimated to be September 2024. Each patient must have a 3 months treatment. We are at the end of July and the study still says Recruiting. Something does not quite add up.
I guess it's possible that they enrolled 400 patients and are enrolling some 'extra' patients to avoid the "Lost To Follow Up" (LTFU), but it's only a 3 months treatment.
I would expect the 'Recruiting' or the 'Primary Completion Date' to change soon on the clinical trials site. Otherwise, something does not add up. And yes, I'm still bullish (very much so).
My 2 cents.
Best of luck with your investments!
Clinical Trials 'Update': Keeping to the estimated dates.
The latest update, dated 2024-07-23 , is simply ... the date of the update, nothing else has changed.
In particular, the estimated primary completion date and study completion date remain the same as it's been since the trial was first entered in Clinical Trials.
I take that as a sign that enrollment continues as planned and that the Company keeps executing to the plan for an FDA submittal at the end of 2024.
Looking good!
Best of luck with your investments!
Hello HyperPhoenix1,
Your guess as to why the PPS is not rising more rapidly would be as good as any.
Mine is caution after the FDA CRL last year. I believe that Norse 8 will lead to US approval in mid-2025 and that may be what 'the Market' is looking at, together with the first quarter of sales in Germany and the UK. In other words, the Market sense may be that there is time to invest at this point. From my perspective, I see it as an opportunity to add.
Once sales kick in, I do not see the PPS going lower, and as a few of us on this board (including you) are 'guestimating', the PPS could rise quite significantly to warrant a serious investment. I don't need a specific PPS target on a calendar date. I need to know the business model makes sense and the probability for executing on the plan is high.
Best of luck with your investments!
I took a closer look, I really like the structure you put together. I may play with slightly different numbers on my free time. You put together a really nice and clear model.
Thanks so much!
Best of luck with your investments!
Hello HyperPhoenix,
Thank you for clarifying the basis for the hypothesis, that makes sense.
Très cordialement,
H2R
Best of luck with your investments!
Hello HyperPhoenix,
Thank you for putting together this work sheet, very appreciated.
The assumptions are taken from the XL :
Number Injections, 2024
France 1,032,783 Based FrenchHealth Database (2016) plus market growth
Europe 6,905,772 Pro Rata based on the french propulation vs EC
UK 1,032,783 UK has same population than France
USA 9,139,783 I used the ratio of treated patients (US/Europe) according to OTLK ppt
OTLK hitting again a planned date, here ahead of time.
This Company has a great track record of executing along announced planned dates and hitting those dates.
During the June 18th presentation, Russ Trenary said they could have a decision from the UK in the next 30 to 60 days. It took even less time.
Best of luck with your investments!
ONS-5010 v. "risk of rare but potentially devastating endophthalmitis" of compounds
Thanks for highlighting this paragraph OGBritBox!
The full sentence from King's College London to be read in light of the legal aspects of approved ONS-5010 v. un-approved Bevacizumab:
" Additionally, a well-controlled pharmaceutical manufacturing operation will allay concerns that compounding pharmacies increase the risk of rare but potentially devastating endophthalmitis."
Who wants to be liable for potential damage to the eye when compound should not be used after approval from a legal standpoint?
Best of luck with your investments!
UK Approval PR
ISELIN, N.J., July 08, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma) for the treatment of retina diseases, today announced that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for LYTENAVA™ (bevacizumab gamma), an ophthalmic formulation of bevacizumab for the treatment of wet AMD in the UK. LYTENAVA™ (bevacizumab gamma) is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in the EU and UK.
Professor Tim Jackson, PhD, FRCOphth, Consultant Ophthalmic Surgeon, King's College Hospital and Professor of Retinal Research, King’s College London, commented, “We have waited a long time for a brand of bevacizumab that is authorized for eye use, and it is good news that LYTENAVA™ has now entered the market. This occurs subsequent to Outlook Therapeutic's clinical trial meeting its endpoint. To date, many ophthalmologists have been hesitant to use an off-label bevacizumab, when licensed products are available. We value being able to utilize products that meet the standards required for marketing authorization. Additionally, a well-controlled pharmaceutical manufacturing operation will allay concerns that compounding pharmacies increase the risk of rare but potentially devastating endophthalmitis.”
This approval comes after Outlook Therapeutics was recently granted Marketing Authorization for LYTENAVA™ (bevacizumab gamma) by the European Commission for the same therapeutic indication. The Marketing Authorization Application (MAA) submission to the MHRA was completed under the new International Recognition Procedure (IRP), which allows the MHRA to rely on a positive opinion by the European Medicines Agency’s CHMP concerning an application for granting marketing authorization for the same product in the EU in the MHRA’s authorization decision.
“We are pleased to receive UK approval on the heels of marketing authorization in the EU for LYTENAVA™ (bevacizumab gamma). This milestone achievement is the final regulatory step towards our expected commercial launch in the EU and UK in the first calendar quarter of 2025. Our team continues to make a concerted effort to bring to the UK market the first and only authorized ophthalmic bevacizumab for the treatment of wet AMD. We are grateful to all the patients, researchers, clinical sites and the MHRA for the research, drug development, and regulatory efforts that led to this approval,” commented Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics.
Jedd Comiskey, Senior VP – Head of Europe for Outlook Therapeutics, added, “MHRA approval represents a very important milestone for Outlook in the execution of our commercial launch plans for LYTENAVA™ (bevacizumab gamma) in the UK. Our team continues to work hand in hand with our commercialization partner, Cencora, to support our launches in the EU and UK anticipated in the first calendar quarter of 2025, and we are looking forward to an exciting year ahead.”
As part of a multi-year planning process, Outlook Therapeutics entered a strategic collaboration with Cencora (NYSE: COR) (formerly AmerisourceBergen) to support the commercial launch of LYTENAVA™ globally following regulatory approvals.
Cencora will provide comprehensive launch support in the EU and the UK including pharmacovigilance, regulatory affairs, quality management, market access support, importation, third-party logistics (3PL), distribution and field solutions. The collaboration and integrated approach is designed to support market access and efficient distribution of LYTENAVA™ to benefit all stakeholders, including retina specialists, providers and patients.
“We have been working closely with Outlook Therapeutics to develop and execute a global launch strategy and are thrilled to help them bring this therapy to market in the UK and the EU,” said Cencora’s John W. Arena, interim president of Global Pharma Services and senior vice president of Enterprise Strategy & Solutions. “We will continue to leverage our infrastructure and pharmaceutical services to support a successful commercial launch of LYTENAVA™ and ensure healthcare providers have timely and reliable access to the therapy.”
UK MHRA Marketing Authorization of LYTENAVA™
That's one news I was hoping for !
* UK MHRA marketing authorization follows recent European Commission Marketing Authorization for LYTENAVA™ (bevacizumab gamma) in the EU for the treatment of wet AMD
* Initial commercial launches of LYTENAVA™ (bevacizumab gamma) in the EU and UK anticipated in calendar Q1 2025
* Strategic partnership with Cencora (formerly AmerisourceBergen) to support the planned commercial launches of LYTENAVA in UK and EU
Thanks Thermo,
Consistent information from BTIG, the Company keeps executing on a clear plan, and additional information (for me anyways) around Compound Pharmacies, starting with
Compounding will become a question of supply, not just demand once ONS-5010 is available. Only two compound pharmacists, Fagron (FSE: FAGR.BR, Not Rated) and Leiters (Private), obtain bevacizumab via distributors. These two pharmacies are unable to ramp up production meaningfully if needed due to the thin margins on bevacizumab. Other compound pharmacists, such as Pine (Private) (responsible for producing almost half of all off-label bevacizumab injections), receive bevacizumab through drop-shipments from physicians. If physicians choose not to ship IV bevacizumab to compounders, we expect the manufacture of off-label bevacizumab as a whole will start to decrease. We are already starting to see physicians shift away from off-label bevacizumab. Mgmt. shared that KOLs are already starting to acknowledge the shortcomings of off-label bevacizumab in reaching ophthalmologic standards. With greater education and increased awareness, mgmt. expects more physicians will opt for an approved product and stop facilitating the manufacture of off-label bevacizumab.
Hi Tex18,
Best is to listen to the latest presentation, available from here:
https://ir.outlooktherapeutics.com/news-and-events/event-calendar
For your question, start around minute 17 . In summary:
* Labeling
* Production ramp up / supply
* Pricing / Government discussions
* Access to payers / insurances / country by country
They might be able to start during the holiday period (might), but they prefer not to launch during that time.
Best of luck with your investments!
Aspirational revenue of $2.5B
The following is a simple back of the envelope estimate of aspirational revenue and MC.
Russ Trenary clearly stated the market OTLK is after all current off-label bevacizumab injections in the EU and the US. He provided the following numbers.
* 3.5M injections in the US
* 2.8M injections in the EU
He also gave us a few clues on the pricing over a few presentations
My guess is that it will end up around
* $500 in the US
* $300 in the EU
So the top possible revenue (in a few years, after FDA approval, etc.) would be:
* 300 * 2.8M for the EU = $0.84B
* 500 * 3.5M for the US = $1.75B
=====
* Total Possible Revenue: $2.59B
Norse 8 Current Planning:
* Full enrollment Q3 2024
* Topline Q4 2024
Last month, enrollment was at 30%, so on track.
Russ Trenary during the June 18th investor presentation!
https://ir.outlooktherapeutics.com/news-and-events/event-calendar
UK: in the next month or 2
Could have a decision from the UK on ONS-5010 in the next 30-60 days
Russ Trenary during the June 18th investor presentation!
https://ir.outlooktherapeutics.com/news-and-events/event-calendar
"Ringing the cash register in Europe in 2025" [Russ Trenary during the June 18th investor presentation]
Q1 2025: launch in high pricing countries to set the tone on pricing for other countries, then expand to more EU countries throughout 2025.
OTLK is targeting the entire current Avastin injections, so about 3 million / year in EU and about the same in the US. That's the goal; I had not heard it this clearly thus far.
Payors in the US are looking at the overall cost when starting with off-label and switching to high priced treatments and compare it with ONS-5010 is patients stay on it. That's of interest to payors.
https://ir.outlooktherapeutics.com/news-and-events/event-calendar
And now 60 recruiting sites (out of 60 planned!)
The latest (last?) one is Oakland, California, United States, 94611
The investor's presentation, slide 18, indicates OTLK was planning on 60 recruiting sites:
400 treatment naïve, wet AMD subjects to be
enrolled at 60 US sites
Wondering if Bill Gates recent interview on CBS Face the Nation, talking about Natrium and TerraPower gave a bit of a boost to SMR. Retail investors can't invest in TerraPower but can in SMR. Gates was pretty articulate and highlighted the renewed bi-partisan interest in Nuclear. Looking at SMR more closely would make sense for those folks looking at energy policies and nuclear in particular.
Best of luck with your investments!
Senti Flipper, could this study be one of them?
https://clinicaltrials.gov/study/NCT04348747
* Phase 2
* Checkpoint Inhibitor ( Pembrolizumab / Keytruda)
* Biological: Anti-HER2/HER3 Dendritic Cell Vaccine
* Principal Investigator:Shipra Gandhi,Roswell Park Cancer Institute
?
Best of luck to Patients, NWBO, and Longs!
June 13, 2924 Seeking Alpha Article
Conclusion:
Making money by investing in clinical stage biotechs is notoriously difficult. No matter how good you may view the setup, unexpected hiccups often seem to arise.
In order to make out you have to do well enough on your winners to pay off your losers. I am pegging Outlook with its paltry <$200 million market cap and its chance to share a meaningful chunk of a $15.9 billion market as one of those potential big time winners. I am rating it a strong buy.
June 18th webcast
Live video webcast on Tuesday, June 18th at 12:00 PM ET
ISELIN, N.J., June 11, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on the commercialization and development of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma), for the treatment of retina diseases, today announced that it will present at the Virtual Investor Pitch Conference on June 18, 2024 at 12:00 PM ET.
As part of the event, Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics, will provide an “elevator pitch” and outline the Company’s upcoming milestones. Additionally, investors and interested parties will have the opportunity to submit questions live during the event. Participating companies will answer as many questions as possible in the time allowed.
A live video webcast of the presentation will be available on the Events page of the Investors section of the Outlook Therapeutics website (outlooktherapeutics.com). A webcast replay will be available two hours following the live presentation and will be accessible for 90 days.
Thanks Thermo,
I've liked your projections and the details on Reddit from another poster.
* https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173887120
* https://www.reddit.com/r/OTLK_Investors/comments/18sfaok/otlkbuyout_my_view_of_profits_at_december_22_2023
I'm a bit cagey when it comes to revenue projections, payors, price point, etc. On my side, I see a significant upside given the current MC at less than $200M and I'm good with that. Even with Europe only, the MC should improve on launch/revenue/country by country, so I'm staying invested. It may take 'a while', which in the biotech world is longer than in other industries :)
Then there is the possibility of a buy out. That would not surprise me a bit.
I'm looking forward to read more of your insights. You are one of my favorite posters on IHub.
Have a great day!
Best of luck with your investments!
Hi Zadie420,
After the CRL from the FDA last year, OTLK passed an SPA (semi binding agreement) with the FDA around Norse 8.
"A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)"
OTLK is planning on recruiting about 400 patients from 60 sites (that's why I'm tracking the site numbers) in order to achieve the powering of the study.
IF (a big IF, but really, that's what I'm expecting) Norse 8 is successful, OTLK will submit Norse 8 as the basis for approval of ONS-5010 in the US. This submittal has been and is still planned for the end of the year. (There is planning, then there is reality). Then it's up to the FDA to finally deliver an approval or reject it.
Now, OTLK has been accepted in Europe on the basis of previous trials (which to me should have been sufficient for the FDA as well. I think the FDA is not quite straight with OTLK, but that's my own take), and the 3 months Norse 8 should confirm that (again, my opinion).
So I'm tracking a couple of things on the US side:
* The number of recruiting sites: 59 for now, they may not need 60, but they planned on it, so maybe one more
* The change in status from Recruiting to another status, like "Active, not recruiting" which might indicate all 400 patients (or a bit more) have been enrolled.
On the status change milestone, you know that the trial has 3 more months to unfold, then data collection, etc., leading to submittal.
Best of luck with your investments!
1 more site, so 59 sites now
* Oceanside, New York, United States, 11572
See: https://clinicaltrials.gov/study/NCT06190093?term=norse%20eight&checkSpell=false&rank=1#contacts-and-locations
They had planned for 60, again, not sure they'll need all, but that's 1 to go if so.
Minor good non-news: Even though the update is dated 5/30 or 6/3 depending on how you read it, the estimate dates remain the same:
* Study Start: January 24, 2024
* Primary Completion: September 2024 [Anticipated]
* Study Completion: October 2024 [Anticipated]
The current list of recruiting sites:
Arcadia, California, United States, 91006
Bakersfield, California, United States, 93309
Beverly Hills, California, United States, 90210
Huntington Beach, California, United States, 92647
Laguna Hills, California, United States, 92653
Long Beach, California, United States, 90807
Modesto, California, United States, 95356
Pasadena, California, United States, 91107
Poway, California, United States, 92064
Sacramento, California, United States, 95841
Colorado Springs, Colorado, United States, 80909
Lakewood, Colorado, United States, 80228
Waterford, Connecticut, United States, 06385
Coral Springs, Florida, United States, 33067
Fort Lauderdale, Florida, United States, 33308
Jacksonville, Florida, United States, 32216
Orlando, Florida, United States, 32806
Stuart, Florida, United States, 34994
Oak Forest, Illinois, United States, 60452
Oak Park, Illinois, United States, 03440
Lenexa, Kansas, United States, 66215
Lexington, Kentucky, United States, 40509
Hagerstown, Maryland, United States, 21740
Edina, Minnesota, United States, 55435
Saint Louis Park, Minnesota, United States, 55416
Jackson, Mississippi, United States, 39202
Teaneck, New Jersey, United States, 07666
Albuquerque, New Mexico, United States, 87109
Liverpool, New York, United States, 13088
Oceanside, New York, United States, 11572
Rochester, New York, United States, 14620
Westbury, New York, United States, 11590
Asheville, North Carolina, United States, 28803
Hickory, North Carolina, United States, 28602
Wake Forest, North Carolina, United States, 27587
Winston-Salem, North Carolina, United States, 27103
Edmond, Oklahoma, United States, 73013
Charleston, South Carolina, United States, 29414
Florence, South Carolina, United States, 29501
Ladson, South Carolina, United States, 29456
West Columbia, South Carolina, United States, 29169
Rapid City, South Dakota, United States, 57701
Germantown, Tennessee, United States, 38138
Abilene, Texas, United States, 79606
Arlington, Texas, United States, 76012
Austin, Texas, United States, 78705
Beaumont, Texas, United States, 77707
Bellaire, Texas, United States, 77401
Dallas, Texas, United States, 75231
Round Rock, Texas, United States, 78681
San Antonio, Texas, United States, 78240
San Antonio, Texas, United States, 78251
The Woodlands, Texas, United States, 77384
Willow Park, Texas, United States, 79606
Salt Lake City, Utah, United States, 84107
Fairfax, Virginia, United States, 22031
Lynchburg, Virginia, United States, 24502
Bellevue, Washington, United States, 98004
Silverdale, Washington, United States, 98383
Best of luck with your investments!
BTIG: $50 PT post European approval
Julian Harrison, an analyst from BTIG, maintained the Buy rating on Outlook Therapeutics (OTLK – Research Report). The associated price target remains the same with $50.00.
Julian Harrison has given his Buy rating due to a combination of factors surrounding Outlook Therapeutics’ recent advancements and market potential. The European Commission’s approval of ONS-5010, branded as LYTENAVA, for the treatment of wet Age-related Macular Degeneration (wAMD) is a significant milestone. With its launch in the European Union on track for the first quarter of 2025, Harrison anticipates that Outlook Therapeutics will leverage its partnership with Cencora for effective market access and distribution, not only in the EU but also in additional markets where LYTENAVA might receive approval. Furthermore, the approval in Europe is seen as a positive indication for the company’s ongoing efforts to address the FDA’s concerns, with a resubmission of their Biologics License Application expected by the end of 2024.
The NORSE EIGHT trial, which is currently underway, is
another reason for optimism
Thanks Thermo
Best of luck with your investments!
On a related note, Market Beat has a PT of $46 i.e. an upside of 485%
https://www.marketbeat.com/stocks/nasdaq/otlk/
I'm curious to see if analysts revise their target after yesterday's announcement.
Best of luck with your investments.
Hi Zadie420
1. The FDA will rely on Norse 8 for approval. OTLK hopes/plans on submital to the FDA in Dec 2024, the FDA then will finalize its decision. I don't know how fast that will be.
2. In terms of revenue, some folks have done detailed projections, such as:
> https://www.reddit.com/media?url=https%3A%2F%2Fpreview.redd.it%2Fotlk-buyout-my-view-of-profits-at-december-22-2023-form-10-k-v0-tknunuoqdx8c1.png%3Fwidth%3D1487%26format%3Dpng%26auto%3Dwebp%26s%3D75d3459965d1c999d07ba9517dd84c1de32b00e7
to estimate a possible buy out at over $5B
or another view from thermo (one of my favorite posters):
> https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173887120
with peak sales at over $500M and market cap at about $2B
anyways, that would drive the PPS significantly up.
Best of luck with your investments!
Hello Thermo,
Your hunch on European approval was spot on.
What do you make of today's PPS action: fairly average volume, going down 12%, recovering towards the end of the day, but with no significant gain overall. The difference between Friday and today is the approval, and yet, not significant bump in the PPS.
Any insight as to what may be happening? as to what will unfold PPS-wise over the course of the next few weeks?
Thanks Thermo!
Best of luck with your investments!
I bought more with the PPS dropping on good news.
The market cap is around $180M, and with approval, the PPS goes down? Yep, I did buy more.
Also, it bodes well for US approval post Norse 8.
Best of luck with your investments!
10 years exclusivity, 27 countries.
European Marketing Authorization for LYTENAVA™ granted!
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-receives-european-commission-marketing
Best of luck with your investments!
Positive or negative, the EU is supposed to give its verdict this week for ONS-5010.
Let's see if they keep to their timetable. I'm cautiously optimistic.
Best of luck with your investments!
European news within a couple of weeks?
That's what the May 14th PR hinted at:
As previously announced, Outlook Therapeutics received a CHMP positive opinion on March 22, 2024 concerning an application for grant of marketing authorization for ONS-5010/LYTENAVA™ in the EU. The European Commission is expected to make a decision within approximately 67 days following the CHMP opinion. The decision will apply automatically in all 27 EU Member States, and, within 30 days, also to Iceland, Norway and Liechtenstein.
May 13 PR: MHRA Submission / Under IRP
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-uk-submission-marketing
Outlook Therapeutics® Announces UK Submission of Marketing Authorization Application (MAA) for ONS-5010 as a Treatment for Wet AMD
May 13, 2024
UK submission for national MAA review follows recently received positive opinion from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) concerning the authorization of ONS-5010/LYTENAVA™ (bevacizumab gamma)
ISELIN, N.J., May 13, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve regulatory approval for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and Europe, today announced the submission of its Marketing Authorization Application (MAA) to the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) seeking authorization of ONS-5010/LYTENAVA™ (bevacizumab gamma) for the treatment of wet age-related macular degeneration (wet AMD).
The submission was completed under the new International Recognition Procedure (IRP), which allows the MHRA to rely on a positive opinion by the European Medicines Agency’s CHMP concerning an application for grant of marketing authorization for the same product in the EU. The IRP is available for new UK MAAs of a medicinal product (having the same qualitative and quantitative composition, and the same pharmaceutical form) that has previously been authorized by a Reference Regulator (RR). In this case this is the EMA.
“The submission of our MAA to the MHRA is another step closer to the possibility of offering clinicians and their patients in the UK market the only on-label, ophthalmic bevacizumab to treat wet AMD,” said Russell Trenary, President and CEO of Outlook Therapeutics. “On the heels of the recent positive opinion by the CHMP in the EU, we continue to make noteworthy progress toward the potential authorization of ONS-5010/LYTENAVA™ in the UK.”
The MAA submission is supported by results from Outlook Therapeutics’ wet AMD clinical program for ONS-5010, which consists of three completed registration clinical trials – NORSE ONE, NORSE TWO and NORSE THREE.
As previously announced, Outlook Therapeutics received a CHMP positive opinion on March 22, 2024 concerning an application for grant of marketing authorization for ONS-5010/LYTENAVA™ in the EU. The European Commission is expected to make a decision within approximately 67 days following the CHMP opinion. The decision will apply automatically in all 27 EU Member States, and, within 30 days, also to Iceland, Norway and Liechtenstein.
2 more sites, so now 58
* Laguna Hills, California, United States, 92653
* Hagerstown, Maryland, United States, 21740
They may go for the 60 planned or not, depending of the recruitment progress. The primary completion and study completion anticipated dates remain the same.
And end of May (European decision) is tip-toeing forward.
Best of luck with your investments!