Outlook Therapeutics Inc (OTLK)

[carp77]

At the rate this stock is dropping you should be able to buy 4 shares for a $1 in February

[H2R]

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.

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-reports-financial-results-fiscal-year-2023

Best of luck with your investments!

[OGBritbox]

I’m betting we are over $1 by February, with SPA granted, FDA approval is almost guaranteed. EU approval will come soon after, (and most likely will with consideration to the FDA response to the BLA (“proven safe and effective meeting primary endpoint's”, and given SPA on a very short 3 month study for approval) will launch this way past $2. I’ve doubled my position since the CRL, putting my money where my mouth is.

[H2R]

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!

[H2R]

US BLA expected by the end of 2024!

Best of luck with your investments!

[H2R]

Planning to start NORSE EIGHT in Q1 2024

Best of luck with your investments!

[H2R]

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.”

Best of luck with your investments!

[OGBritbox]

I think we could see in that they
"fund" 2024 by issuing stock at $1-$2, that will pull up the price, (like they did in Nov 2021 and Dec 2022)
Or Streeterville could convert at $2/share. That will also bring up the price, then the buyer would be the one buying it up. The stock price has to go up before a buyout is announce. Several ways they could do that. Issuing stock is just one.

[Mfgaumond]

Hey Thermo! How’s everything been? Anything going on behind the scenes you might be able to share with us? Wondering if they’ve reached out to you in regards to more funding. Hope all is well!

[H2R]

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.

Are there parties interested in acquiring OTLK??

Best of luck with your investments!

[glenn1919]

OTLK.................................https://stockcharts.com/h-sc/ui?s=OTLK&p=W&b=5&g=0&id=p86431144783

[H2R]

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.

Given the circumstances, this is great news!

Best of luck with your investments!

[OGBritbox]

Today is the deadline to file form 13s, so far none have, which means no insiders or institutions have sold a single share since the CRL,

[OGBritbox]

Thank you !

[H2R]

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.

[thermo]

Not my base case expectation but it's possible.

[OGBritbox]

There is a lot of evidence to support the theory that AmerisourceBergen aka Cencora has been going through the process of acquiring them as a bolt on acquisition. If this is the case, they could very well announce after EU approval and assume the costs so as not to change the share structure. Thoughts ?

[thermo]

Launching a product takes some additional investment, so I don't think that will save them. The company will raise funds either through the sale of common stock or through the sale of a royalty, in my view.

1. Common stock. I think this is most likely. They will likely need to add some warrants to the mix.

2. Royalty. These take a portion of revenue until the investor receives some multiple of the initial investment. The more risk, the higher the multiple. I would guess 3x - 4x in this case.

[Mfgaumond]

I really appreciate the time and the effort you put into your posts/responses. Thank you for your feedback. A lot of people are optimistic about the European approval, but I heard most of the time if a drug isn’t approved in the US they will make the same decision over there. Curious your thoughts on that? Also, in regards to dilution I’m hoping they can somehow figure out an alternate option even though I feel it is inevitable (I know it also hurts them because most of their incentives are stock based).

[OGBritbox]

You didn’t mention European Union approval, which is expected around February. I would have to assume with approval in Europe, they then have a positive cash flow that could sustain them without diluting, and obviously that would also raise investor confidence that FDA approval would follow.

[thermo]

As noted in my earlier posts, I first thought this was an easy approval since management was following guidance* they received from the FDA in 2018. The key decisionmaker changed at the FDA and the new sheriff made a different decision in 2023.

My mistake was thinking that the FDA would make the decision with the highest utility (e.g. we know the drug works, current off label present safety and efficacy risks, as emphasized by the recent Pine Pharma recalls). Instead, the FDA acted like bureaucrats, indifferent to utility. In hindsight, trying to explain why I expected bureaucrats to not behave like bureaucrats is impossible. Frailty of the human mind!

But your question was more about confidence. To answer that question, I would focus to four items.

1. Is the drug safe and effective? I have yet to hear anyone, including bears, claim otherwise**.

2. Can OTLK get FDA approval? Here's how I think about it. OTLK is providing a written plan to the FDA specifying their interpretation what the FDA indicated would constitute substantial evidence of safety and efficacy, as discussed verbally that the recent FDA meeting. The FDA will then confirm. So the risk of approval comes down to whether OTLK can follow directions***. That's a judgement call but, as long as FDA guidance is clear, I will probably bet money that can. OTLK is considering if they should seek an SPA at this point, which will be binding guidance. It will take longer than less formal guidance, but the tradeoff is the cash burn while they wait.

3. Can they raise the funds needed? My short answer is yes. But, as I discussed in an earlier post, this is the crux of the problem. The return for shareholders generally is how much dilution takes place between now and (the highly likely) approval.

4. How will the competitive landscape change over the next two years? My primary concern will be if biosimilars price lower than their current preferred range around $1000 p.d. Historically, biosimilars cos. do not follow a low-priced strategy but the recent approval of high-dose Eylea and the strength of Vabysmo could pressure biosimilars to lower price, putting pressure on the OTLK business model. So, there are arguments either way. My approach on these types of risks is to be aware of them and but to defer conclusions until evidence starts to track one way or another.

* Guidance, not an SPA (though they have those on other indications)
** Even the bears didn't predict an FDA failure, they made other arguments. Better lucky than smart is the oft used wall street phrase.
*** provided we don't have another change in FDA leadership

[maverick_1]

Re Thermo:

Last, I also I want to apologize. I try to be honest and careful with what I write. I hate when I cost people money.

OTLK Thermo Fiasco a BLNRE mezz financier promoter 2016 ONLINE
BUTTRESSED by the other FIASCO's:
193 iHub followers!https://t.co/nvs08M6NTBhttps://t.co/PNsid8iTGD
ALIGNMENT linkS TIMELINE w/ https://t.co/SqdUdfoOvS  
1)$NMTRQ
2)$NWBO
3)$OTLK
4)$CHUC$BLNRE motivation?

— maverick_1 (@maveric92283613) November 3, 2023

[OGBritbox]

HC Wainwright upgraded Outlook Therapeutics to buy, stating that it now sees a “straightforward path to approval” for the company's drug ONX-5010. 
The investment bank noted that it downgraded the stock when the FDA declined to approve the product last summer, believing that the agency would ask for an additional study, with approval potentially pushed out to the end of 2026.
UBS said that while the FDA is requiring an additional study, it appears to be more flexible on the design and duration.
“With the company and FDA in alignment, we see a straightforward path to approval and one in which investors will gain comfort over time,” the bank analysts wrote.
The bank added that it expects the drug to get a positive recommendation from EU regulators in 1H 2024, “which would be a meaningful boost to sentiment.” It raised its probab
ility for success for approval to 65% from 50%, with approval anticipated in mid-2026.

[INV4]

You're welcome H2R! Yes, we were waiting for news on this... unfortunately, we'll have to wait a little longer for a potential FDA approval. Good luck to you/all.
$OTLK

[Mfgaumond]

Very disappointed to say the least. Any feedback on what is going on behind the scenes? Management keeps saying they’re confident and then this happens… pulled BLA, CRL, and now they need a new study. You still confident in this long term or are you feeling like this isn’t going to happen like the rest of us?

[H2R]

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,

To design, file, register, get sites set up, enroll, treat, follow up, file data, gather data, analyze data, etc., it tends to take quite a bit of time. I was surprised by the timeline suggested by the company. How could they do something this fast. OTLK has been one of the few biotechs I follow that has kept to its timeline up to now.

I'm now wondering if they could do it, depending on the request by the FDA on the type of data that's expected. For example:
* Piggy back on an existing, on-going trial, say https://clinicaltrials.gov/study/NCT05112861 as an example. (unlikely I would guess)
* Use a trial they were about to set up and modify it to include relevant data for the FDA
* Have a one arm, open label, short trial. Some of their trials are 3 months studies, like this one for instance https://clinicaltrials.gov/study/NCT04516278?spons=Outlook%20Therapeutics&rank=2&tab=table

One thing is that OTLK has been setting many trials, Norse I, II, III...VII, short trials, double blind studies...

The language of the PR says the OTLK and the FDA "reached an agreement in principle ... on a clinical trial design". Even with a brand new trial protocol, they may be able to leverage the work they've done on some of the other trials to design/re-design a trial that would go after the specific 'substantial evidence' the FDA requires, on a short protocol basis.

Anyways, looking forward to the Webcast. Hopefully we'll hear more specifics on the new trials.

Best of luck with your investments!

[carp77]

And after a r/s and massive dilution what are we looking at?

[maverick_1]

The INEVITABILITY of correctly reading between the lines from OTLK/FDA & Ulterior Motives of a Thermo.

The FDA informed Outlook Therapeutics that an additional adequate and well-controlled clinical trial would be required for the approval of ONS-5010 for the treatment of wet AMD. 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, and subsequent approval around mid-2025,

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, 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. The FDA and Outlook Therapeutics also agreed on the approaches needed to resolve the CMC comments in the CRL and Outlook Therapeutics believes these efforts should be sufficient to support approval.

SEEING The Extremes Limits of Capitalism in last TWO Decades.

The MARKETS are RIGGED: exploited by ALGO's since 2014
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Fallacy of not acknowledging
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DIFFERENT STROKES for DIFFERENT FOLKS

[whosleftholdindabag]

Back in $OTLK 1.5M shares. Now that we have clarity this is the bottom! GLTA

[shurtha2000]

this should go below .20

[H2R]

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.

OTLK will need to design the trial, fund it, enroll it, complete it, etc. All that in one year. When it's on clinicaltrials.gov, it will give us a more concrete sense of the trial design and some of the relevant details.

Thanks again.

Best of luck with your investments!

[INV4]

Outlook Therapeutics® Provides Update on Type A Meetings with FDA

ISELIN, N.J., November 2, 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 it has completed the requested Type A Meetings with 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.

The FDA informed Outlook Therapeutics that an additional adequate and well-controlled clinical trial would be required for the approval of ONS-5010 for the treatment of wet AMD. 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, 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. The FDA and Outlook Therapeutics also agreed on the approaches needed to resolve the CMC comments in the CRL and Outlook Therapeutics believes these efforts should be sufficient to support approval.

“We are confident that we can meet the additional requirements that the FDA is requiring for approval of ONS-5010. The retina community of patients, physicians and payers are all in need of an FDA-approved bevacizumab that meets ophthalmic standards for the treatment of wet AMD, and we remain focused on achieving this critical treatment option,” said Russell Trenary, President and CEO of Outlook Therapeutics.

About Outlook Therapeutics, Inc.
Outlook Therapeutics is a biopharmaceutical company working to achieve FDA approval for the launch of ONS-5010/ LYTENAVA™ (bevacizumab-vikg) as the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO. The FDA accepted Outlook Therapeutics’ BLA submission for ONS-5010 to treat wet AMD with an initial PDUFA goal date of August 29, 2023; FDA did not approve the BLA during this review cycle and the Company is working with the FDA to address the issues that have been raised so that the BLA may be re-submitted. If ONS-5010 ophthalmic bevacizumab is approved, Outlook Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal diseases in the United States, United Kingdom, Europe, Japan, and other markets. As part of the Company’s multi-year commercial planning process, Outlook Therapeutics and Cencora, formerly AmerisourceBergen, entered into a strategic commercialization agreement to expand the Company’s reach for connecting to retina specialists and their patients. Cencora will provide third-party logistics (3PL) services and distribution, as well as pharmacovigilance services and other services in the United States. For more information, please visit www.outlooktherapeutics.com.

https://ih.advfn.com/stock-market/NASDAQ/outlook-therapeutics-OTLK/stock-news/92441460/form-8-k-current-report

$OTLK

[H2R]

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!

[INV4]

Outlook Therapeutics® to Present at Guggenheim’s 5th Annual Inflammation, Neurology & Immunology (INI) Conference

November 01 2023 - 08:05AM
GlobeNewswire Inc.

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 Russell Trenary, President and CEO of Outlook Therapeutics will participate in a fireside chat at Guggenheim’s 5th Annual Inflammation, Neurology & Immunology (INI) Conference, being held in New York, NY on Tuesday, November 7, 2023 at 1:50 PM ET.
In addition to the fireside chat, management will be available to participate in in-person one-on-one meetings with qualified members of the investor community who are registered to attend the conference.

A live audio webcast of the fireside chat will be accessible on the Events page in the Investors section of the Company’s website (outlooktherapeutics.com). A webcast replay will be archived for 90 days following the event.

About Outlook Therapeutics, Inc.
Outlook Therapeutics is a biopharmaceutical company working to achieve FDA approval for the launch of ONS-5010/ LYTENAVA™ (bevacizumab-vikg) as the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO. The FDA accepted Outlook Therapeutics’ BLA submission for ONS-5010 to treat wet AMD with an initial PDUFA goal date of August 29, 2023; FDA did not approve the BLA during this review cycle and the Company is working with the FDA to address the issues that have been raised so that the BLA may be re-submitted. The submission is supported by Outlook Therapeutics’ wet AMD clinical program, which consists of three clinical trials: NORSE ONE, NORSE TWO, and NORSE THREE. If ONS-5010 ophthalmic bevacizumab is approved, Outlook Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal diseases in the United States, United Kingdom, Europe, Japan, and other markets. As part of the Company’s multi-year commercial planning process, Outlook Therapeutics and Cencora, formerly AmerisourceBergen, entered into a strategic commercialization agreement to expand the Company’s reach for connecting to retina specialists and their patients. Cencora will provide third-party logistics (3PL) services and distribution, as well as pharmacovigilance services and other services in the United States. For more information, please visit www.outlooktherapeutics.com.

CONTACTS:

Media Inquiries:
Harriet Ullman
Vice President
LaVoieHealthScience
T: 617.429.5475
[e-mail]

Investor Inquiries:
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 833.475.8247
[e-mail]

https://ih.advfn.com/stock-market/NASDAQ/outlook-therapeutics-OTLK/stock-news/92426533/outlook-therapeutics-to-present-at-guggenheim-s

$OTLK

[INV4]

$OTLK Going up!

[OGBritbox]

What are we looking at Glen? I mean, technically

[OGBritbox]

The FDA is supposed to reply to type A meeting requests within 14 days, with a meeting held within 30 days of that request, which technically is tomorrow . Now I’m assuming it’s 30 calendar days, not business days as it would be otherwise stated on the FDA website. My guess is they got a response, and had the meeting but are keeping us in the dark because retail shareholders aren’t who they are working for now. They will only give us PR’s they are obligated to. We will know if I am right 30 days from now when the FDA minutes for the meeting become public. They can’t hide that. This is a clear BO. My guess is the CRL was not an accident, it allowed the buyer to take in much more of the float from retail, and they are targeting approval to align with EU in February, with BO announced soon after.

[thermo]

I don't think the meeting has taken place yet. They may have gotten a written response from the FDA to their meeting request (which include questions they would like addressed at the meeting).

[glenn1919]

OTLK................................https://stockcharts.com/h-sc/ui?s=OTLK&p=W&b=5&g=0&id=p86431144783

[Mfgaumond]

I’m surprised they haven’t come out with any information yet. I would assume they already had the meeting. Any thoughts on the huge volume spikes over the last week and a half?

[INV4]

Blackrock owns a lot of shares here... of all the institutional holders in OTLK, they are the largest holder.
1. BLACKROCK INC. | 06/30/2023 | 9,215,800 shares

https://www.nasdaq.com/market-activity/stocks/otlk/institutional-holdings

$OTLK

[INV4]

$OTLK looking good.

[INV4]

I think you're right H2R!

Putting those two together... this week for a Type A?

It looks like the stock wants to move higher today.
GLTA $OTLK

[H2R]

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.

Now put that together with the Cantor Fitzergarld

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.

Putting those two together... this week for a Type A?

Best of luck with your investments.

[INV4]

$OTLK on the move again?

[glenn1919]

OTLK........................https://stockcharts.com/h-sc/ui?s=OTLK&p=W&b=5&g=0&id=p86431144783

[H2R]

20M shares exchanged, another fairly big volume day.

[H2R]

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

[H2R]

124,291,101 shares exchanged today.

News on the horizon? Leak? PR? Very intriguing!

Best of luck with your investments!

[H2R]

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!