Outlook Therapeutics Inc (OTLK)

[StonkMaster]

Much appreciated!

[thermo]

Let me check my own trading...ah, yes, as recently as 2 days ago was adding to my current holdings.

The insider purchases obviously drove prices up. Not sure if Biden cap gain tax proposal will whack the market much. Always some macro stuff that can derail a forecast.

But, it's a very good long. Should rally into pivotal data due 3Q and, if one studies the trial design, pretty likely to show clinical benefit.

[StonkMaster]

You would say now is a good time to enter OTLK thermo?

Thank you.

[thermo]

OTLK, a great long right now

[pfelgueiras]

OTLK COMMERCIAL PLANNING ACTIVITIES UNDERWAY
With an enhanced safety and cost-effectiveness profile, Outlook Therapeutics expects ONS-5010 to be widely adopted by payors and clinicians worldwide and to become the first-line drug of choice for payor-mandated “step edit” in the United States for retinal indications:
1) Physician and Patient Outreach
2) Aligning Key Opinion Leaders
3) Payor Community Engagement

[pfelgueiras]

OTLK COMPANY HIGHLIGHTS
• Lead product candidate ONS-5010 / LYTENAVATM has potential to be first FDA-approved ophthalmic formulation of bevacizumab for use in multiple retinal indications 24
• Potential FDA Approval in 2022
• Targeting $13.1 Billion Global Ophthalmic Anti-VEGF Market1
• Potential for 12 Years of Market Exclusivity • Management Team with Extensive Clinical/Regulatory Ophthalmology & Drug Development Experience

[pfelgueiras]

OTLK Is in "BUY Zone" for BIG PROFITS with the next 3 catalyst events:
1) Ongoing Phase 3 pivotal trial with topline data expected Q3 2021
2) Biologics License Application (BLA) submission on Q4 2021.
3) BLA FDA Approval in 1Q 2022.
After "Phase 3" topline data, OTLK "can have" a Buyout, I think above $50.

[pfelgueiras]

OTLK New Corporate Presentation.

https://ir.outlooktherapeutics.com/static-files/d69330f5-ef3b-4f65-976f-1c687a038c75

Reconfirme all data and expectations.
My OTLK Price Target is $25 until 1Q 2022.

[H2R]

... And the OTLK PR on Norse III

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-reports-positive-safety-profile-norse-three

Outlook Therapeutics Reports Positive Safety Profile from NORSE THREE Open-Label Safety Study for ONS-5010 / LYTENAVA™ (bevacizumab-vikg)
March 31, 2021

Positive safety profile in NORSE THREE open-label safety study reinforces previously reported safety data for ONS-5010 / LYTENAVA™, an investigational ophthalmic formulation of bevacizumab-vikg for the treatment of wet AMD

Topline efficacy and safety data from pivotal Phase 3 NORSE TWO study on target to report in calendar Q3 2021, followed by BLA submission by end of 2021

MONMOUTH JUNCTION, N.J., March 31, 2021 (GLOBE NEWSWIRE) --

Outlook Therapeutics, Inc. (Nasdaq: OTLK), a?late clinical-stage?biopharmaceutical company?developing the first FDA-approved ophthalmic formulation of bevacizumab-vikg?for use in retinal?indications, today announced positive topline results from its NORSE THREE open-label safety study evaluating ONS-5010 / LYTENAVA™ (bevacizumab-vikg) to treat retinal diseases.

Topline results from the open-label safety study demonstrated that ONS-5010 showed no unexpected safety trends and had a safety profile consistent with that of prior published data on the use of bevacizumab for ophthalmic conditions, such as the 2011 CATT study undertaken by the National Eye Institute. The safety endpoints for NORSE THREE were the frequency and incidence of treatment-emergent adverse events and an evaluation of changes in safety parameters. In the study, 20 out of 197 patients (10%) experienced an adverse event in the study eye that were most commonly associated with the injection procedure and not ONS-5010. There were no serious adverse events associated with treatment. Notably, there were zero cases of ocular inflammation, a concern that has emerged for other anti-VEGF (Vascular Endothelial Growth Factor) therapies to treat retinal conditions.

“The additional validation of the ONS-5010 safety profile seen in the results of this study, which match up favorably with historical data from prior studies of bevacizumab in ophthalmology, is very encouraging. ONS-5010 has the potential to be a valuable therapeutic addition to the clinical practice of retina physicians. I look forward to the topline data readout from the pivotal safety and efficacy study later this year,” said Mark Humayun, MD, PhD, Medical Advisor to Outlook Therapeutics.

NORSE THREE was conducted to ensure that an adequate number of patient exposures to ONS-5010 / LYTENAVA™ are available for Outlook Therapeutics’ data package for its planned biologics license application (BLA) submission in the United States and for other global regulatory filings. The open-label study met its goal of ensuring that a sufficient number of individuals have now been treated with ONS-5010 by enrolling 197 treatment-naïve and previously treated subjects with a range of retinal diseases for which an anti-VEGF drug is a therapeutic option, including wet age-related macular degeneration (wet AMD), diabetic macular edema (DME) and branch retinal vein occlusion (BRVO). Subjects enrolled in the study received three monthly intravitreal doses of ONS-5010 / LYTENAVA™.

Following the data readout of the pivotal safety and efficacy study (NORSE TWO) later this year, Outlook Therapeutics plans to submit a new BLA filing under the PHSA 351(a) regulatory pathway in the fourth quarter of calendar 2021. If the BLA is approved, it will result in 12 years of marketing exclusivity for ONS-5010 / LYTENAVA™ as the first and only FDA-approved ophthalmic formulation of bevacizumab-vikg to treat wet AMD.

Commercial launch planning for ONS-5010 has begun, including manufacturing, distribution, physician and patient outreach, and engagement with key opinion leaders and the payor community. With potential for an enhanced safety and cost-effectiveness profile, ONS-5010, if approved, is well positioned to become the first-line drug of choice in the United States for retinal indications and to be widely adopted by payors and clinicians worldwide in the $13.1 billion global anti-VEGF market.

“We are very pleased with the positive safety profile demonstrated by ONS-5010 in this open-label safety study. This study provided us with the necessary number of patient exposures to ONS-5010 to complete our planned BLA submission for wet AMD later this year,” said Lawrence A. Kenyon, President, CEO and CFO of Outlook Therapeutics. “These results reinforce the positive safety profile seen in our earlier clinical experience trial. Moving forward, our team is now laser-focused on successfully completing our pivotal trial, NORSE TWO, and preparing the BLA after the data readout expected in the third quarter of this calendar year. On behalf of the Outlook Therapeutics team, we would like to thank the clinicians and patients who participated in this study, despite the disruptions of the pandemic.”

In addition to the clinical development plan evaluating ONS-5010 for wet AMD, Outlook Therapeutics has received agreements from the FDA on three Special Protocol Assessments (SPAs) for three additional registration clinical trials. These SPAs cover the protocols for a planned registration clinical trial evaluating ONS-5010 to treat BRVO (NORSE FOUR), and two planned registration clinical trials evaluating ONS-5010 for the treatment of DME (NORSE FIVE and NORSE SIX). Outlook Therapeutics expects to initiate registration clinical trials for ONS-5010 for DME and BRVO later in 2021.

Best of luck with your investments!

[H2R]

Positive results from NORSE THREE study in retinal disease

Mar. 31, 2021 8:20 AM ET

Outlook Therapeutics (NASDAQ:OTLK) announces positive topline results from its NORSE THREE study evaluating ONS-5010/LYTENAVA (bevacizumab-vikg) to treat retinal diseases. ONS-5010 showed no unexpected safety trends and had a safety profile consistent with that of prior data on the use of bevacizumab for ophthalmic conditions.

The safety endpoints for NORSE THREE were the frequency and incidence of treatment-emergent adverse events and changes in safety parameters.

In the study, 20 out of 197 patients (10%) experienced an adverse event most commonly associated with the injection procedure and not ONS-5010. There were zero cases of ocular inflammation.

Following the data readout of NORSE TWO later this year, Outlook plans to submit a new BLA filing in Q4.

If approved, it will result in 12 years of marketing exclusivity for ONS-5010/LYTENAVA as the first and only FDA-approved ophthalmic formulation of bevacizumab-vikg to treat wet AMD.

OTLK shares up 2.8% premarket trading at $2.24.

https://seekingalpha.com/news/3678013-outlook-therapeutics-reports-positive-results-from-norse-three-study-in-retinal-disease


Best of luck with your investments!

[thermo]

The primary reason for the shelf offering is to provide a stronger negotiating position with any strategic partner after pivotal data is reported.

[now invest]

Hopefully will stay here until next week... when I expect more cash to free up..... only havebsmall position ... started yesterday!! GOOD LUCK HERE!!

[pfelgueiras]

What will be Cathie Wood next prediction on ARK Funds?
Cathie Wood predicted Tesla.. then Cathie predicted Bitcoin.. she also predicted Genomics was the next huge breakout and severely undervalued..
I think for "ARKG" one of the next Cathie prediction it will be "OTLK" Outlook Therapeutics as it is a disruptive, innovative and undervalued company.
It's more of a question of WHEN Cathie takes a position in OTLK.
OTLK is:
a) Targeting $13.1 Billion Global Ophthalmic Anti-VEGF Market.
b) 12 years market exclusivity under new BLA.
c) Become first-line "step-edit" drug of choice.
d) Penetrate USA, EU, Australia and other developing markets.
BUY THE RUMORS SELL THE NEWS!

[johnreiner]

OTLK a sleeping GIANT!

[pfelgueiras]

Today OTLK +17% Now at $2,36
Institutional Holders increasing their positions, new Institutional Holders buying, and also shorts closing their positions.
Lets squeeze the shorts.

My sugestion Bullish and Long for 1 or 2 years is OTLK
PRICE TARGETS: (Zacks+Nasdaq+TipRanks $5,00) ; (Barchart [Strong Buy]+ MarketBeat+CNN+WallStreetZen $6,00) ; Yahoo $4,88 ; MarketWatch $6,00/$5,00/$3,50) COVERTURE: Ladenburg Thalmann $9,00 ; Oppenheimer $12,00 Outperformer
Institucionais Sabby Managment, Vanguard, Armistice, Geode Capital, Two Sigma.

https://ir.outlooktherapeutics.com/.../a08b36df-0cdb-4c11...

1. Pivotal phase 3 data due July/August timeframe
2. They have enough cash to get through filing BLA for FDA Approval (in Q4) after data release.
3. They are continuing negotiations with potential partners, and believe the cash they now have gives them a much better position to that end.
These are the only relevant issues through the EOY. Beyond that while awaiting FDA approval, they will either have a partnership deal, buyout offer, or will need to raise more money for marketing, distribution, sales etc. to go it alone, which the additional shares can and will be used for, such the need arise. If approved, ONS-5010 will become the first line drug of choice for payor-mandated “step edit” in the US for retinal indications, estimated to be a $13 billion dollar market, and growing significantly.
My investment and target OTLK 40.000 shares x $25 = $1.000.000

[johnreiner]

[StableGenius]

What is the dosing interval in P3 trial? I did not find it in the online FDA information.

[thermo]

Unfortunate that the COO and CMO sold a portion of their holdings. I followed up with management and am comfortable that it was solely tax motivated… no concerns re fundamentals.

[johnreiner]

Top analysts rate OTLK with a BUY rating and a $6 price target!

https://zolmax.com/investing/outlook-therapeutics-nasdaqotlk-stock-rating-reaffirmed-by-ladenburg-thalm-sh-sh/5480849.html https://zolmax.com/investing/outlook-therapeutics-nasdaqotlk-stock-rating-reaffirmed-by-ladenburg-thalm-sh-sh/5480849.html

[johnreiner]

https://quantisnow.com/insight/404497?s=s

[PennyWorld]

Just reposting insider buying same info I believe.....

Transaction Date Insider Name Title Buy/Sell Number of Shares Average Share Price Total Transaction Shares Held After Transaction Details

2/3/2021 Syntone Ventures Llc Major Shareholder Buy 3,000,000 $1.00 $3,000,000.00 19,823,045

2/2/2021 Ghiath M Sukhtian Director Buy 8,360,000 $1.00 $8,360,000.00

[H2R]

TLD (open-label) NORSE THREE on target for Q2 2021

This is the kind of news I do like to see from a biotech company planning to submit a BLA in Q4/2021. It means the pieces of the puzzle are falling into place and the planned timeline looks good.

This PR is about Norse 3, but you can see how it all plays in their building the case for the BLA submission.

I hope the Company keeps PR'ing these types of milestone. Very encouraged.

MONMOUTH JUNCTION, N.J., Feb. 11, 2021 (GLOBE NEWSWIRE)

Outlook Therapeutics, Inc. (Nasdaq: OTLK), a?late clinical-stage?biopharmaceutical company?working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced that the last patient completed their final visit for the ongoing open-label safety study evaluating ONS-5010/LYTENAVA™ (bevacizumab-vikg) to treat retinal diseases (NORSE THREE).

Two of the three planned clinical trials for the ONS-5010 / LYTENAVA™ wet age-related macular degeneration (wet AMD) U.S. Biologics License Application (BLA) are now completed. The open-label safety study enrolled 197 subjects, in only 4 weeks, with a range of retinal diseases for which an anti-VEGF drug is a therapeutic option, including wet AMD, diabetic macular edema (DME) and branch retinal vein occlusion (BRVO). Subjects enrolled in the study received three monthly intravitreal (IVT) doses of ONS-5010 / LYTENAVA™. The data from this study is expected to be reported in the second quarter of calendar 2021 and will be included in the complete data package to support the planned BLA for wet AMD, on schedule for submission to the U.S. Food and Drug Administration (FDA) in the fourth quarter of calendar 2021.

“We sincerely thank the clinicians and study participants for their commitment and dedication to completing this safety study in this ongoing pandemic environment. The NORSE THREE study plays a key role in our overall ONS-5010 registration program. With the last patient visit now completed in this study, we are focused on the successful completion and data readout for the pivotal NORSE TWO Phase 3 study of ONS-5010 for the treatment of wet AMD, followed by our planned BLA submission,” added Lawrence A. Kenyon, President, CEO and CFO, Outlook Therapeutics.

Following the data readout from both the open-label safety study and the pivotal safety and efficacy study, Outlook Therapeutics plans to submit a new BLA filing to the FDA under the PHSA 351(a) regulatory pathway. If the BLA is approved, it will result in 12 years of marketing exclusivity for ONS-5010.

Commercial launch planning has begun, including distribution, physician and patient outreach, key opinion leader support and payor community engagement. With an enhanced safety and cost-effectiveness profile, Outlook Therapeutics expects ONS-5010, if approved, to be widely adopted by payors and clinicians worldwide and to become the first-line drug of choice for payor-mandated “step edit” in the United States for retinal indications.

In addition to the clinical development plan evaluating ONS-5010 for wet AMD, Outlook Therapeutics has received agreements from the FDA on three Special Protocol Assessments (SPAs) for three additional registration clinical trials. These SPAs cover the protocols for a planned registration clinical trial evaluating ONS-5010 to treat BRVO (NORSE FOUR), and two planned registration clinical trials evaluating ONS-5010 for the treatment of DME (NORSE FIVE and NORSE SIX). Outlook Therapeutics expects to initiate registration clinical trials for ONS-5010 for DME and BRVO later in 2021.

Best of luck with your investments!

[H2R]

Thanks Thermo,

I appreciate your thoughts. I definitely helps me. I'll be in for at least until the tld later on this summer and then I'll see where this might go.

And if you do have the time to put together more info ... :)

Cheers!

[thermo]

Yes, your analysis is similar to mine. When I have time, I’ll post something in more detail.

Summary:

$500M - $1B peak revenue forecast USA & EU.

Assumed ASP of 300 $/dose. After conversations with management, I think ASPs may be higher.

Assuming gross margins of 75%.

Assuming 12 yrs. exclusivity wAMD. May be opportunity to extend.

Getting prefilled syringe approval will increase penetration. Expect this to follow 1.5 years after wAMD FDA approval.

Your peak revenue multiple look reasonable. I’m at 5x revenue, but I’m probably low. Bad habit of mine.

Milestones:

- 2Q 2021: safety study data released
- August 2021: pivotal wAMD data
- YE 2021: wAMD filing USA
- late 2021/early 2022: initiate NORSE 4
- late 2021/early 2022: initiate NORSE 5
- late 2021/early 2022: initiate NORSE 6
- 1H 2022 wAMD: filing Europe
- Late 2022: BRVO filing
- 2023: DME filing

Risk are new innovative products, but there's not been a much progress recently:

- Roche eyes an uncertain market for faricimab | Evaluate

- Roche amps up its bispecific attack on Eylea with more PhIII data — but just how threatening is it? – Endpoints News (endpts.com)

- Safety scare knocks Novartis' Beovu | Evaluate

- US regulator still doesn’t buy abicipar | Evaluate

- Why Regenxbio’s eye gene therapy would have to be the cheapest yet | Evaluate

- Conbercept: New Generation of Product for Treatment of nAMD Completes 36-week Primary Endpoint Visits of Phase III Trial (yahoo.com)

- FDA issued a complete response letter for the Darpin anti-VEGF molecule

[H2R]

Hi Thermo,

I wonder if you would indulge me. I'm trying to figure out the potential for OTLK.

Context

1) The projection a few years out of the AMD seems to be around $11B
https://www.globaldata.com/age-related-macular-degeneration-market-will-rocket-11-5bn-2026/?source=content_type%3Areact%7Cfirst_level_url%3Aarticle%7Csection%3Amain_content%7Cbutton%3Abody_link

2) OTLK estimates a $13B market for FDA-approved anti-VEGFs for ophthalmic use
https://outlooktherapeutics.com/lytenava-overview/

3) There is currently no bevacizumab approved for ophthalmic indications in the United States
https://outlooktherapeutics.com/lytenava-clinical-progress/

4) OFF LABEL Avastin has a lion share of the market (at least US?)
“Based on GlobalData’s primary research, in the US around 50% of patients with wet AMD are prescribed Avastin
https://www.globaldata.com/nhs-victory-bayer-novartis-significant-impact-uk-ophthalmology-sales-says-globaldata/?source=content_type%3Areact%7Cfirst_level_url%3Aarticle%7Csection%3Amain_content%7Cbutton%3Abody_link

Rough Estimate
IF ONS-5010 is indeed approved for those markets, it seems that a $500M revenue would be a conservative peak sales estimate.

In the world of biotech, I see market cap from 5 to 10 times the revenue. 7 times would mean an MC of $3.5B, or over 7 times the current MC.

Your thoughts?
How does the above estimate jive with your own thoughts? Is that in the ball park of your own estimate?

Thanks for your thought!

Best of luck with your investments!

[BoilerRoom]

$OTLK $3.99

[BoilerRoom]

$OTLK $3.80

[BoilerRoom]

$OTLK $3.42

[thermo]

I believe the strike is $12.

$1.50 x 8 (upon prior reverse split)

[H2R]

OTLK is a beast!

I rarely have had the opportunity to get in at $1.00 (exactly), thanks to Thermo on NWBO as you mentioned, and be at > $3 in about a week.

The volume keeps being way above the 90 days average.

Best of luck to your investments!

[biotechnician]

OTLKW exercise price?

[Red_Right_Hand]

thermo, thanks for this. saw your mention on the NWBO board when it was at $1.00

[TrendTrade2016]

OTLK gapping...volatility ends soon!!

[BioInvestor4]

No way! Staying In That for sure!

[jm100]

hello are you leaving n-b-

[thermo]

Insider Syntone Ventures LLC reports buying 3,000,000 shares of $OTLK / Outlook Therapeutics, Inc. at a total cost of $3,000,000.00

[thermo]

Thanks. Fortunately got a lot of my friends in too, which I find gratifying. Not used to getting paid so quickly. We're in a strange market.

[H2R]

Big gain, big volume!

From my $1 PPS a week ago (thanks Thermo!) or so -> around $1.7 now. The volume, as of now, today is 16,692,055 compared to a 90-Day Average Volume 1,710,128!

Best of luck with your investments!

[H2R]

Form-4:
http://archive.fast-edgar.com/20210202/A6ZZN222Z22222E2222L2CZ2JFOTZH28BN32/

Acquisition at $1 from an OTLK director. Looking good.

Best of luck with your investments :)

[thermo]

Guessing we'll see more insider buying... but, only a guess.

[johnreiner]

https://www.globenewswire.com/news-release/2021/02/02/2168613/0/en/Outlook-Therapeutics-Announces-Closing-of-35-0-Million-Bought-Deal.html

[thermo]

Coherus is discontinuing the development of CHS-2020 (Eylea® biosimilar candidate) and will direct those capital and development resources to the toripalimab monotherapy and combinations program.

+ for OTLK

[1sdestiny]

Thanks for your post. It’s great following someone like you on these boards.

[H2R]

I'm starting small and will grow my position as I dig a bit.

From reading a couple articles, it seems to me that the PhIII trial is going after the of current 50% market share, the top contender, Roche's off-label Bevacizumab (Avastin) aiming for an FDA approved comparable product, at a lower price point, and likely better payer support (if FDA approved of course).

The downside is a strong and established competitive landscape against large companies (sales force/marketing/...).

There seems to be a strong upside on good TLD given the current MC at about $100. The $1 / share looks like it could definitely go some ways.

If we assume a peak sale of $250 million, then the net present value (11% discount rate) for the drug would be around $325 million, which is nearly three times the price of the market cap of the company at this point.

https://seekingalpha.com/article/4370981-outlook-therapeutics-interpreting-new-phase-3-trial-results

That same article talks about a global market around $11B in 2026. $250M peak sale seems like a fairly conservative peak sale. Thermo (see post earlier) estimates peak at between $500M-1B. That would translate into a phenomenal MC, i.e a return > 10x.

Finally, the last raise seems to give them some pretty good runway. I have not looked at the burn rate tough. Anyways, a stock to watch for sure.

As usual with clinical stage biotechs, lots of happen before TLD. The Company talks about mid 2021 TLD, which, as we know, may be an optimistic target but gives a sense of the timeframe. Data lock was in

Best of luck and again, thanks to Thermo for the tip :) Really appreciated.

[Karlchen]

hello guys, fellows from . . . .
put it to my watchlist for may/june 2021. looking in the meantime how OTLK develops. Currently there are so much (too many) better plays out there. beneath our core-investment, look at magicmushrooms, shrooms, with psilocybin as treatment for depression, mental health - new paradigmshift - its beginning to be legalized, already in canada and some states in the us. (like canabis years ago)
es Karlchen (not the GREAT)

[thermo]

There are a few obvious choices with OTLK. Buy @ ~ $1.00 p.s. and:

1. Sell 2Q 2021. Clinical development companies generally trade up into release of important trial data if data is likely good. One has the option of taking the trade without any clinical data risk. My guess is stock will be at $1.50 - $2.00.

2. Hold through data release, long term. First data risk is lower than normal (I’d say 80% - 90% success likelihood. See * for why). Second, peak revenue estimate is impressive $500M - $1B. Third, gross margins are strong. Assume ASP of $300 per dose with direct costs of less than $50 => gross margins of ~75%. What does the market pay for $500M of peak revenue at 75% GM? Say 5x => yields $2.5B versus current market cap of $165M including the shares just issued. That’s 15x the current price**

* In this case there is less data risk than usual because Bevacizumab is very well understood. The OTLK pivotal trial is basically a replication of earlier Ranibizumab studies but this ONS-5010 as the treatment arm instead of Ranibizumab. The CATT trial showed that Bevacizumab efficacy is equivalent to Ranibizumab.

** I will caveat the 15x forecast by noting that small companies usually screw up. So, there will be other product development efforts and more share issuances. Those are wild cards.

[BioInvestor4]

I’m jumping in too!

[thermo]

Outlook Therapeutics – new position for me today.

Overview
1. Clinical-stage biopharmaceutical company seeking Bevacizumab-vikg (ONS-5010) approval in Neovascular Age-related Macular Degeneration (Wet AMD).
a. Become first-line “step-edit” drug of choice
b. Product is biosimilar to Bevacizumab. Bevacizumab first approved in the United States in February 2004 for metastatic colorectal cancer. Used in other cancers. Well understood.
c. ONS-5010 meets ophthalmic criteria. E.g. USP 789 for particulates (General Chapters: <789> PARTICULATE MATTER IN OPHTHALMIC SOLUTIONS (uspbpep.com)).

2. File as new BLA with FDA – 12-year exclusivity.
a. End of phase 2 meeting with FDA.
a. Confirmed availability of BLA pathway.
b. Same study design used for Wet-AMD, Branch Retinal Vein Occlusion (DME) and Branch Retinal Vein Occlusion (BRVO)
c. FDA granted Special Protocol Assessment for DME and BRVO. See: Outlook Therapeutics Receives FDA Agreement for Three Special Protocol Assessments for Additional Planned Clinical Trials of ONS-5010 - Outlook Therapeutics, Inc.
d. Since study designs of nAMD same as DME, believe design will be acceptable to FDA.
e. OTLK submitted SPA for wAMD. Received comments and incorporated into study. Didn’t want to wait for final SPA, since first to file provided exclusivity.

b. Expect data release July/August 2021.
c. File BLA with FDA by year end 2021, EU 1H’2021.
d. In discussion with European regulators for filing using same data.
a. FDA / EU requires 9 / 12 mos of stability data on GMP batch. So FDA will file with FDA first.
b. Have 9 months of data November 2021
e. Approval: 2022 USA, 2023 EU

3. Solving public health concerns of using off-label Bevacizumab (Avastin).
a. Current off label use of compounded Bevacizumab raises issues with correct potency, infection.
i. Intravitreal preparations of bevacizumab acquired from compounding pharmacies => 81% had lower protein concentrations (mean [SD], 22.2 [4.9] mg/mL; range, 19.2-24.5 mg/mL) compared with bevacizumab acquired directly from Genentech. See: https://pubmed.ncbi.nlm.nih.gov/25233052/
b. Pre-filled syringe would be best solution. A syringe pre-filled with ONS-5010 likely to follow 1 – 1.5 years after approval of vial form.

4. Commercialization
a. Off label Bevacizumab used in 50% of Wet-AMD cases (USA) and 30% of cases (Europe)
b. Payor discussion on pricing. Expect strong support for product.
c. if they get ¼ - ½ of off label beva to switch to approved version => peak revenue of $500M - $1B.

[Glider549]

Bummer guys.
I just stick with Covid, Cancers and 'Mens libido' meds.

[ClayTrader]

* * $OTLK Video Chart 07-16-2020 * *

Link to Video - click here to watch the technical chart video