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The FDA SPA agreement is in!
I keep being impressed with management clarity on planning, deadlines, and execution!
Outlook Therapeutics® Receives FDA Agreement Under Special Protocol Assessment (SPA) for 90 Day Non-Inferiority Study, NORSE EIGHT, and Announces Private Placement of Up to $172 Million to Advance ONS-501
* Obtained clarity from U.S. Food and Drug Administration (FDA) on next steps to advance ONS-5010
* NORSE EIGHT expected to commence in the first quarter of CY2024, enabling potential resubmission of the ONS-5010 Biologics License Application (BLA) by the end of CY2024
* Private placements to top tier institutional investors and insiders include up to $65 million in common stock and up to an additional $107 million upon cash exercise of warrants, subject to closing conditions
*Aggregate financing, subject to achievement of milestones, is expected to be sufficient to take ONS-5010 through potential FDA approval and fund commercial launch
Hi hyperopia,
Thank you so much for the scenarios.
What would you expect to be the first indication of the remaining timeline.
For example, if high priority is assumed, would you expect a PR after the first 80 days + a few days from NWBO or an information from MHRA to indicate an RFI or a non RFI, so say end of march?
Thanks again!
Best of luck to Patients, NWBO, and Longs!
2024 OTLK Anticipated Milestones
FDA response on NORSE EIGHT Special Protocol Assessment (SPA) in early February 2024;
Commencement of NORSE EIGHT expected in first calendar quarter of 2024;
MAA decision date in the EU for ONS-5010 expected targeted for first half of 2024;
Completion of NORSE EIGHT in the U.S. anticipated in 2024; and
Resubmission of the ONS-5010 BLA expected by the end of calendar year 2024.
Norse 8: 3-month study, primary endpoint at 2 months. n=400
Now let's see when the FDA approves the SPA. Then it's off to the races for Norse 8.
Best of luck with your investments!
US BLA expected by the end of 2024!
Best of luck with your investments!
Planning to start NORSE EIGHT in Q1 2024
Best of luck with your investments!
SPA Protocol Submitted!
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-submits-special-protocol-assessment-spa
ISELIN, N.J., Dec. 19, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced that, following receipt of written confirmation of the NORSE EIGHT proposed clinical trial protocol with the U.S. Food and Drug Administration (FDA), Outlook Therapeutics has submitted a Special Protocol Assessment (SPA) request for the required additional adequate and well-controlled study of ONS-5010.
As previously announced, following the Type A meeting with the FDA held in October 2023, the FDA informed Outlook Therapeutics that it can conduct a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 3-month study of treatment naïve patients with a primary efficacy endpoint at 2 months. Subsequently, as discussed with and recommended by the FDA, Outlook Therapeutics submitted a clinical trial protocol and requested a Type A meeting with the FDA for feedback. The FDA has since provided written feedback on the protocol, which Outlook Therapeutics has incorporated. The revised protocol is the subject of the SPA request, in which Outlook Therapeutics is seeking further confirmation from the FDA that NORSE EIGHT, if successful, addresses the FDA’s requirement for a second adequate and well-controlled clinical trial to support the resubmission of the ONS-5010 BLA for wet AMD. The FDA is expected to provide a response to the SPA in early February 2024.
NORSE EIGHT will be a randomized, controlled, parallel-group, masked study of neovascular age-related macular degeneration subjects randomized in a 1:1 ratio to receive 1.25 mg ONS-5010 or 0.5 mg ranibizumab intravitreal injections. Subjects will receive injections at Day 0 (randomization), Week 4, and Week 8 visits. Approximately 400 patients are expected to be enrolled in the study.
Outlook Therapeutics expects to resubmit the ONS-5010 BLA by the end of calendar year 2024 to include the results of NORSE EIGHT and the additional CMC work to address the issues identified by FDA in the Complete Response Letter issued in August 2023 to support approval.
“We have been working closely with FDA to meet the remaining requirements provided by the Agency to support approval of ONS-5010. Based on our ongoing discussions with FDA, we believe we have agreement on a clinical trial protocol. With the SPA now submitted, we are preparing to start NORSE EIGHT in the first quarter of 2024,” commented Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics. “We remain dedicated in our pursuit to achieve U.S. FDA approval for the first ophthalmic formulation of bevacizumab and look forward to providing further updates.”
Looking at M&A more closely?
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-strategic-organizational
Effective immediately, Joel Prieve, formerly the Senior Vice President of Commercial Operations, has been appointed to the role of Senior Vice President of Licensing and M&A. In this role, he will be responsible for developing and executing the Company's strategy in the areas of licensing and partnerships, as well as evaluating and executing potential merger and acquisition opportunities.
Rooting for you Flipper44.
Best of luck to Patients, NWBO, and Longs!
Resubmission on track for EoY 2024!
Resubmission of the ONS-5010 BLA on track for the end of calendar year 2024, pending final agreement on a clinical trial protocol with the FDA and successful completion of the required additional clinical trial
Planned clinical trial expected to be a 3-month non-inferiority study with 60 day efficacy endpoint
ISELIN, N.J., Nov. 27, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced the receipt of the official minutes from the Type A meeting with the U.S. Food and Drug Administration (FDA) held in October 2023 regarding the Complete Response Letter (CRL) dated August 29, 2023 for the Biologics License Application (BLA) for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD.
As previously reported, the FDA requires an additional adequate and well-controlled study to support the ONS-5010 BLA. The FDA has informed Outlook Therapeutics that it can conduct a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 3-month study of treatment naïve patients with a primary endpoint at 2 months. As recommended by the FDA at the Type A meeting, Outlook Therapeutics has been working with the Division of Ophthalmology to design an appropriate study to satisfy the FDA’s requirements. The FDA and Outlook Therapeutics have also identified the approaches needed to resolve the CMC comments in the CRL.
“We are encouraged by the productive discussions we have had with the FDA regarding next steps for our ONS-5010 approval pathway. We continue to believe in the potential of ONS-5010 to address the need here in the United States, as well as globally, for an approved ophthalmic bevacizumab that meets FDA standards for the treatment of wet AMD,” commented Russell Trenary, President and CEO of Outlook Therapeutics.
Based on the October Type A meeting and ongoing informal discussions with the FDA, Outlook Therapeutics has submitted a protocol for review at an upcoming Type A meeting with the FDA in December 2023. Upon confirmation of the protocol details with the FDA, Outlook Therapeutics intends to submit a Special Protocol Assessment (SPA) to memorialize the agreement with the FDA on the trial design and confirm that, if successful, this additional study, in combination with the successful completion of the ongoing work related to the CMC requests in the CRL, would support approval of a resubmitted ONS-5010 BLA. Outlook Therapeutics continues to believe that the proposed clinical trial design as included in the Type A meeting request would allow for completion of the study in 2024 and resubmission of the ONS-5010 BLA by the end of calendar year 2024.
Guggenheim Nov.7, 2023 Notes
https://guggenheim.metameetings.net/events/ini23/sessions/48835-outlook-therapeutics-inc-otlk/webcast?gpu_only=true&kiosk=true
The sound is better than during the live broadcast. My notes below
Q: Overview of OTLK
Russ: goes over the basics of ONS-5010
- Off-label Avastin, $100/injection; 'untoward things can happen during the packaging process'
- OTLK's goal is to have an FDA approval for ONS-5010 with strong standards
- 2 years of pricing research with both doctors and payors, "large swim lane"
- Norse II build upon past trial; successful Norse II on the endpoints; Safety and Efficacy
- Norse III open label
- PDUFA on Aug 29th: CRL
- FDA indicated some CMC: came up with new items which could have been asked way earlier via IR
- FDA wanted to see additional confirmatory evidence, additional clinical evidence
- OTLK set up a Type A meeting which happened a couple weeks ago
- OTLK made their case with all the pre trial and trial meetings with the FDA, OTLK thought they were on track
- Getting the CRL was a surprise, given the guidance, the meeting minutes, etc.
- FDA wants a second study. ("Everyone who got approved before had a second study" which I find bizarre)
- OTLK asked repeatedly what exactly the FDA wanted to cover
- OTLK waiting for the minutes of the meeting
- OTLK feels the verbal agreement from the FDA is well understood and can lead to an end of 2024 results to the FDA
- Instead of a Norse II duration, it's more like a one year duration
- Waiting for details so the new trial will match the FDA direction
Q: How many patients for the new trial
Russ: FDA does not require a number of patients but a p-value (the usual 0.05 value)
So new trial powered for p-value
A manageable number of patients to enroll in a couple of quarters
Q: Norse II FDA feedback?
Russ: Great feedback on the primary and secondary endpoints and p-values. "You met all your endpoints"
Showed superiority.
well controlled trial on the dosing
Q: "Norse IV" (?) SPA? (Note: One of the points I really wanted to hear about)
Russ: OTLK will do its utmost to get the FDA 'bound' to the new demands
Will talk to their attorneys on the benefits of an SPA
Do not want to go through a never ending cycle/delay
OTLK wants a written up FDA memorialization of the requirements
Q: Other information, on Avastin, other
Russ: "doctors were universally eager to help, be a part of the next study"
already have the biggest names in the US to participate in the next study
1. they liked the results of Norse II and during the next trial, their patients will get great care
2. they want this product
Q: Do you have your product ready to go (.. for the next trial)
Russ: (happy chuckle) "We do" OTLK had built some initial inventory; can be used in the next trial
AmerisourceBergen: "We love this product" "We are standing shoulder to shoulder" with OTLK
Brings in their network, payors, contracting, distribution, etc.
Enduring relationship
Q: 100-200 patients : funding needs
Russ: $100K/patients in a trial, so if 200, 300, 400 patients, that's 20, 30, 40 million.
Then about 2 million burn rate without trial, well controlled burn rate
So for an 18 months period, a combination of the number of patients + burn rate.
Q: pricing with regards to biosimilars, coming in a couple of years.
Russ: Ironically, pricing is going higher. Pricing study stands.
Still aiming for the same 'corridor'.
OTLK will be well positioned going forward pricing wise.
Payors, doctors; pricing research on point for OTLK
Q: Update before the end of the year?
Russ: hoping for that timeframe for an update and for certainty on what the FDA wants.
Utah Associated Municipal Power Systems (UAMPS) and NuScale Power Agree to Terminate the Carbon Free Power Project (CFPP)
Am I reading this right? ouch.
Despite significant efforts by both parties to advance the CFPP, it appears unlikely that the project will have enough subscription to continue toward deployment. Therefore, UAMPS and NuScale have mutually determined that ending the project is the most prudent decision for both parties.
"Through our work with UAMPS and our partnership with the U.S. Department of Energy, we have advanced our NuScale Power Modules™ to the point that utilities, governments and industrials can rely on a proven small modular reactor (SMR) technology that has regulatory approval and is in active production. Our work with CFPP over the past ten years has advanced NuScale technology to the stage of commercial deployment; reaching that milestone is a tremendous success which we will continue to build on with future customers," said NuScale President and Chief Executive Officer John Hopkins. "NuScale will continue with our other domestic and international customers to bring our American SMR technology to market and grow the U.S. nuclear manufacturing base, creating jobs across the U.S. We thank UAMPS for the collaboration that has enabled this advancement."
"This decision is very disappointing given the years of pioneering hard work put into the CFPP by UAMPS, CFPP LLC, NuScale, U.S. Department of Energy, and the UAMPS member communities that took the leadership role to launch the CFPP," said UAMPS Chief Executive Officer and General Manager Mason Baker. "Yet, this decision is the best course for the UAMPS members participating in the CFPP and doing what is best for those member communities will always be the guiding light in such decisions. We have learned many invaluable lessons during the development of the CFPP that we will carry forward in future development work to meet the future energy needs of the UAMPS member communities. We look forward to continuing to provide innovative and cost-effective new resource solutions to our members, and, at the same time, we hope NuScale is successful in deploying its technology."
Timeline
During the meetings, Outlook Therapeutics reached an agreement in principle with the FDA on a clinical trial design that would most likely allow for the resubmission of the ONS-5010 BLA as early as the end of calendar year 2024,
Thanks INV4,
That's the type of information we are all waiting on. It's hard to believe an actual trial is required, and that the new trial would be this "fast"
a clinical trial design that would most likely allow for the resubmission of the ONS-5010 BLA as early as the end of calendar year 2024, and subsequent approval around mid-2025, pending final agreement on a clinical trial protocol with the FDA and successful completion of the required additional clinical trial.
Thanks INV4,
Hopefully part of the talk will touch on the Type A meeting, outcome, and remediation steps. I'll definitely listen to the Webcast.
Best of luck with your investments!
Thanks BrightBoy,
Type A meeting within a week??
Outlook Therapeutics® Requests Type A Meeting With FDA
September 29, 2023
PDF Version
ISELIN, N.J., Sept. 29, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced that a Type A Meeting request has been submitted to the U.S. Food and Drug Administration (FDA) to discuss the Complete Response Letter (CRL) dated August 29, 2023 regarding the Biologics License Application (BLA) for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD.
20M shares exchanged, another fairly big volume day.
Cantor Global Healthcare Conference
September 26, 2023 1:35 p.m. ET11'30
A couple of notes. Nothing earth-shattering.
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-present-2023-cantor-fitzgerald-global
See the live video link
11'30'' Currently, pricing and efficacy lead to about 50% of the market to repackaged bevacizumab.
14' In the trial, Russ talks about the one -one! - minor safety concern, treated and resolved. Excellent safety profile.
15'30'' As long as you make ONS5010 is within reach. Asked payors, doctors what pricing ought to be. ONS-5010 pricing should be in line with the response OTLK received.
16'34'' OTLK will provide a briefing document to the FDA to address and at the same time will request an FDA meeting.
The FDA has 30 days to meet once the request is issued.
Unclear as to the request date. "Soon" is not precise.
Anyways, just a couple of notes.
Best of luck with your investments
124,291,101 shares exchanged today.
News on the horizon? Leak? PR? Very intriguing!
Best of luck with your investments!
105M shares up to now.
When the CRL was announced, the volume was then 140M. That was on actual news. The volume has been moving up in the last week. It's not a few retails that would make this type of volume.
I'm wondering if some news leaked, if the Type A meeting did happen (with some positive items) but has not been PR'd yet, or what. This is highly unusual.
Best of luck with your investments!
Thanks Thermo,
As always, I (and many others I think) appreciate your input.
Cheers!
Best of luck with your investments!
Hello Thermo,
Since we have not had news about the Type A meeting, I was wondering why the PPS has made some movement lately.
I noticed the Oct. 2023 six Form 4s listed here:
* https://ir.outlooktherapeutics.com/financial-information/sec-filings
which looks like a few people have been acquiring a nice amount of shares.
Would you have any insight as to why by any chance? You might know some of the investors.
Thanks,
Best of luck with your investments!
Data Centers in Ohio and Pennsylvania
https://www.powermag.com/nuscale-gets-a-win-with-smrs-for-data-centers-in-ohio-and-pennsylvania/
Standard Power, a provider of infrastructure as a service to advanced data processing companies, has chosen NuScale Power’s small modular reactor (SMR) technology to power two facilities it plans to develop—one in Ohio and the other in Pennsylvania. ENTRA1 Energy, an independent global energy development and production company, will support Standard Power’s two projects.
Hi Termo,
That's how I see it too. The long term value is still at play, provided the Company can address the issues.
What I heard in the Webcast yesterday could be set up a two parts issues:
* CMC issues, which they seem to think should be addressable / clarification, new questions. (I was a bit surprised at that given the previous CRLs and inspections)
* The substantial evidence. That's the one I would like to have some real definition, so would the Company.
As you write, the Type A meeting outcome will hopefully let us know.
As far as money lost, we make our decisions based on the info we have. If I lose money, I'm not going to point fingers. I've been an adult for long enough :)
The top line data was superb, the market opportunity is there.
And I, as many others I believe, do appreciate your insights.
Cheers!
Volume today: 139M v. Average of 1.5M
When news hit (whichever way), volume sky rockets in the biotech / pre-market companies.
From the Webcast, a few notes:
1. Norse 2 efficacy & safety P values great; (Powered at 90%, whatever that means, one of the last questions)
2. CMC Issues: "a couple of new things" .."a couple of clarifications".
3. "lack of substantial evidence"? Could be additional evidence, but not clear at all as to what part of the trial or manufacturing it relates
4. Debt/finances: They seemed relatively confident as they have a long term relationship with lenders
5. Question on launch prep. They did not address the sales force or other employees they may have hired. They said they have a stock of products ready for packaging/labelling.
6. The question I was most expecting (came in late!) was about the necessity of a new trial. That is not clear at this stage. One question in the CRL seem to relate to the trial itself.
The main point is OTLK will prepare questions and a briefing package for a Type A meeting on the CRL issues. The FDA has 30 days after receiving that package to hold the Type A meeting.
Best of luck with your investments!
Complete Response Letter (CRL) :((
Ouch! That stings!
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-provides-regulatory-update-fda-review-ons
The PPS is now 0.4, dropped immediately.
Volume of 7.7M shares today v. a 90 day average of 1.4M. What volume tomorrow and after PDUFA decision?
That should be interesting.
Best of luck with your investments!
PDUFA Day -1
Unless the FDA pushes the deadline out, the decision will be out today or tomorrow.
I'm hopeful for a positive decision.
Best of luck with your investments!
Been wondering about the recent PPS.
One possible reason is the latest from REGN:
https://www.investors.com/news/technology/regn-stock-climbs-as-fda-approves-high-dose-eylea-why-the-approval-could-not-come-soon-enough/
and the price pressure REGN and NVS are under.
Just a thought. I'm holding OTLK.
Best of luck with your investments!
Thanks for the message Thermo, a stock halt would make sense.
The PPS action lately is 'interesting'. I was thinking getting close to the PDUFA would move the PPS up, not down. Anyways, holding at the very least until the decision (unless bombshell news emerges, unlikely this late in the game). I'm curious what the PPS will do after that. Biotech never ceases to surprise me.
Best of luck with your investments!
Last lap before PDUFA decision. A few days left before, hopefully, approval, after the traditional long clinical trial marathons, a culmination of years of work.
Less than 10 calendar days. To put in perspective:
August 30, 2022, Resubmittal after CRL
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-re-submits-biologics-license-application
March 31, 2022 First submittal to the FDA
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-submits-biologics-license-application-us
August 3, 2021, top line data:
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-reports-positive-efficacy-and-safety-data
July 16, 2019 First Patient in the Second Phase 3
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-doses-first-patient-second-phase-3-clinical
October 5, 2015 Primary and Secondary Endpoints in Phase 1
https://ir.outlooktherapeutics.com/news-releases/news-release-details/ons-1045-avastinrbevacizumab-biosimilar-meets-primary-and
Investments in biotech is not for the faint of heart. We are about to get the news, it could be any time before the 29 too. I can wait :)
Best of luck with your investments!
Got another (small) slice at $1.39 at the open.
I checked the news, the outlook site, twitter, etc. ...Since I still don't see why the drop, I added a bit.
Best of luck with your investments!
Thanks Thermo,
I'm glad you took the time to answer.
(I had been wondering about the 'cost of launch', in terms of sales, training, outreach to payors, physicians, inventory, etc.. )
If the Company does raise post FDA approval in order to start commercial operations, I think that's a great use of capital.
Anyways, 15 days til FDA decision! (And if positive, it bodes well for EMA).
Best of luck with your investments!
Another slice at $1.48
I don't understand the PPS drop today, over 7%. I checked the news, nothing weird.
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-reports-financial-results-third-quarter
The 3rd quarter report is what's expected, with the PDUFA date kept on Aug. 29th.
Upcoming Anticipated Milestones
> PDUFA goal date of August 29, 2023;
> Evaluation of ONS-5010 in a pre-filled syringe in the NORSE SEVEN clinical trial expected to be complete in 2024; and
> MAA decision date from the EMA’s CHMP in the EU for ONS-5010 expected in first half of 2024.
Commercial Planning Underway to Support Potential Approval of the First Ophthalmic Formulation of Bevacizumab for Use in Retinal Indications