Outlook Therapeutics Inc (OTLK) News

OMG, are we friends again?

Thanks.

Norse 8 powering is 95%.

I'm less familiar with the EU as well. Even though the company is talking (and planning) for EU launch, it's more likely they out license, in my view.

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

Typical biotechs valuations go around 10 times revenue. I don't think that would be the case here.
Let's say it's 4 times.

The aspirational market cap in the full possible market capture would be greater than $10B.

Say they only achieve half of that market: $5B MC.
Today, the MC is below $200M. 25 times the MC in say 4 years.

You can play on the price per injections and the % of the bevacizumab off-label injections OTLK will capture.
The number of off-label injections is now a known entity: we can use that as a solid estimation data point.
The moral of this exercise is that the upside can be very large over the medium term.

Best of luck with your investments!

Simple thesis to US approval (EU already in hand): known therapeutic profile + SPA
Agreed. There is still some chance of trial failure on pure bad luck. I have not seen the powering assumptions, but if powered at 85-90% then there is a 10-15% chance of S*** happens. Other than that, hard to see what can go wrong for the FDA.

Then one needs to develop a view on revenue, which is also a fairly simple exercise since we know that off label bevacizumab is widely used and, if an approved product is available, regulations prohibit the use of an off-label product*.
Tell that to AMRN longs

I do think it does well in the US though for obvious reasons. If I was a patient I would certainly prefer the FDA approved version to one some chemist put together in the back room. And for insurance companies, a no brainer to prefer it over the high priced VEGFs,.

Not sure about EU. I admit I do not know enough about those markets (as it is country by country), but do know that pricing issues can be messy.

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
https://ir.outlooktherapeutics.com/static-files/2cfae876-3be2-46cb-aa75-aca673544481

The update to cliniclaltrials does not change the estimated dates, which indicates the planning is being kept:
* Study Start2024-01-24 [Actual]
* Primary Completion2024-09 [Estimated]
* Study Completion2024-10 [Estimated]

OTLK continues to execute on their plan.

Best of luck with your investments!

The 60 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
Oakland, California, United States, 94611
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

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.

Best of luck with your investments!

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.

Best of luck with your investments!

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!

Good summary H2R. Simple thesis to US approval (EU already in hand): known therapeutic profile + SPA

Then one needs to develop a view on revenue, which is also a fairly simple exercise since we know that off label bevacizumab is widely used and, if an approved product is available, regulations prohibit the use of an off-label product*.


* there may be low usage, but it's a pretty strong deterrent.

Thanks for great detail explanation. Interesting FDA had CRL regarding the effectiveness of ONS-5010 but EU has approved this drug last month. This shows how corrupt FDA is.

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!

H2R- I forgot what these sites for study? Is OTLK going after another indication

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!

Almost as if they want retail to sell.

What is going on here. Since the EU approval PPS has been coming under pressure and the company does not say anything. Hmm. This is very strange.

Agreed. There is absolutely no evidence to show Hope has sold his position. Unless they are golfing Troon together. And if so, why blow the whistle on his bud to a bunch of strangers.

Thermo, I was wondering why you think the relative share price weakness following the EMA approval is due to a significant shareholder selling his position. You cite disclosures from end of last year and beginning of this year to support your argument.
Given the unexpected low ADTV following the approval couldn’t it be more the seemingly missing interest and accumulation of institutional investors that “weighs” on the share price? Thanks.

I wonder what the PPS would be if they go for FDA approval?

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. This trial is designed to compare ONS-5010 with a leading treatment, ranibizumab, and if successful, could further validate the drug’s efficacy. Additionally, Outlook Therapeutics has the potential to position ONS-5010 competitively in terms of pricing and reimbursement, which could disrupt the current preference for compounded bevacizumab among retinal specialists due to its lower cost. The management’s discussions with payors suggest a willingness to support a transition to ONS-5010, which could offer a more desirable balance of affordability, efficacy, and quality. Harrison’s analysis also includes a valuation based on a net present value sum-of-the-parts approach, taking into account the potential for additional capital through warrant exercises, which adds to the company’s financial stability and supports his positive outlook on the stock.

In another report released on May 17, (note: before European approval) H.C. Wainwright also reiterated a Buy rating on the stock with a $30.00 price target.

https://markets.businessinsider.com/news/stocks/buy-rating-justified-by-outlook-therapeutics-advancements-and-market-prospects-1033428932

Best of luck with your investments!

I’m just curious as to what made you think that Mr. Hope, of all people, is selling. Especially if there hasn’t been any filings

I'm speculating that he is trying to sell his position.

Also pointing out that there are different responses to a large seller:
(a) do they know something bad that you don't know => get the hell out
(b) do they know the same things you know, but just have a different view => hold but realize that the investment thesis may not be compelling yet
(c) are they selling for reasons unrelated (or only slightly related) to the asset in question => aggressively add on a cleanup trade

I don't think "a" applies here. "b" maybe, but "c" likely.

Are you saying that Jason Hope sold out?

Thanks thermo for clarification. As you said hope this is temporary and reverse in PPS performance should be soon.

I had the right idea but the wrong seller. Not 100% sure (pretty sure though) but I think OTLK weakness is due to the 13G filer below. His cost basis is much higher and was not included in the recent transaction. He doesn’t possess any material private information, so the weakness should be temporary and not impact our longer-term economics.

13G filing

If true, we should see 13/G amendment 45 days following the 2Q quarter end.

Filing Date: 2023-02-21
SOLE VOTING POWER: 20,000,000 => 1,000,000 split adjusted

The SEC Adopts New Timing Requirements for Beneficial Ownership Reporting

Amendments to any Schedule 13G filing must be made within 45 days after the end of the calendar quarter in which any reportable change occurs. In addition, Qualified Institutional Investors must file an amendment within five business days (previously 10 days) after month-end in which such Qualified Institutional Investor’s beneficial ownership first exceeds 10% of a covered class or any 5% increase or decrease in beneficial ownership of a covered class. Passive Investors must file an amendment within two business days (previously “promptly”) after such Passive Investor’s beneficial ownership first exceeds 10% of a covered class or any 5% increase or decrease in beneficial ownership of a covered class. The SEC further provided that the triggering event for filing amendments under Schedule 13G is a “material” change in the information previously provided vs. “any” change in the information previously provided.

Very disappointed with price action today. Hope better days are ahead given the OS is very low. OTLK can release a PR discussing their plan for FDA submission. Given the EU approval I don't think we have any issue getting the approval in US.

Thanks for the info thermo. One must also take in account that 11.3% of float shares are traded short.

Thanks Thermo

Best of luck with your investments!

I DIDN'T MEAN 1(a). I meant "2".

I have some understanding of the shareholder, and believe selling is motived by a liquidity concern.

The stock trades poorly, no doubt.

Seller(s) can be motivated by
1. information
(a) something we don't know that is bad
(b) something we all know but we (long holders) view differently
2. by circumstances that are not related to the investment value
e.g. a seller with a liquidity need may have to sell.

My best guess is we are dealing with 1(a).
SCHEDULE 13D
(Name of Issuer) Outlook Therapeutics, Inc.

Tenshi Healthcare Pte. Ltd.
36 Robinson Road
#13-01 City House
Singapore, 068877
Attn: Executive Director

(Filing Date) January 25, 2024

Holdings as of filing date: 16,637,024 (this is pre reverse, so => /20) => 831,851 shares


Between November 28, 2023 and January 30, 2024, the Reporting Persons sold an aggregate 2,714,469 Shares of the Issuer’s common stock in open market transactions for aggregate gross proceeds of $1,290,131,39 as follows:

Sold a total of 135,723 shares (split adjusted)

Date of Transaction / Number of Shares Sold / Price per Share / Gross Proceeds / Nature of Transaction
November 28, 2023 100,000 $0.47720 $47,720.00 Open market sale
November 29, 2023 65,044 $0.48010 $31,227.62 Open market sale
November 29, 2023 200,000 $0.48129 $96,258.00 Open market sale
November 30, 2023 167,958 $0.48036 $80,680.30 Open market sale
November 30, 2023 134,956 $0.48060 $64,859.85 Open market sale
December 1, 2023 61,283 $0.48000 $29,415.84 Open market sale
December 5, 2023 34,015 $0.45370 $15,432.61 Open market sale
December 6, 2023 207,062 $0.45000 $93,177.90 Open market sale
December 8, 2023 700 $0.45000 $315.00 Open market sale
December 20, 2023 208,306 $0.45220 $94,195.97 Open market sale
December 22, 2023 6,034 $0.45000 $2,715.30 Open market sale
December 27, 2023 80,606 $0.48010 $38,698.94 Open market sale
December 27, 2023 112,861 $0.49410 $55,764.62 Open market sale
December 28, 2023 57,606 $0.45540 $26,233.77 Open market sale
December 29, 2023 32,088 $0.45520 $14,606.46 Open market sale
December 29, 2023 19,105 $0.45460 $8,685.13 Open market sale
January 23, 2024 123,289 $0.48820 $60,189.69 Open market sale
January 23, 2024 100,000 $0.50930 $50,930.00 Open market sale
January 23, 2024 100,000 $0.50030 $50,030.00 Open market sale
January 24, 2024 116,220 $0.45000 $52,299.00 Open market sale
January 24, 2024 427,600 $0.50200 $214,655.20 Open market sale
January 25, 2024 210,880 $0.45010 $94,917.09 Open market sale
January 25, 2024 98,500 $0.45140 $44,462.90 Open market sale
January 30, 2024 50,356 $0.45000 $22,660.20 Open market sale
Total 2,714,469 $1,290,131,39

The thing is the population is getting old and more seniors will develop wet AMD. I think there are less than 900K cases in US and probably similar cases in Europe. Also, we need to consider the ones in Asia specially Japan/China. With proper marketing this has a potential getting much higher PPS than if is reported by analyst. I think there is a good chance the competitor will buy OTLK. They always do that to keep up with revenue.

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.

Thanks for prompt response.

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!

H2R- You have been a shareholder of OTLK. What is the potential revenue based on approval from EU and FDA. I expect FDA approval will be swift and fast. I notice that they have less than 25 mil shares OS which is very low and if they make $200 Mil revenue it could result in explosion of PPS. Yesterday I was surprised by PPS action., Tia.

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!

what a scam shitty f..ng market we're all in!?

OTLK recieves Marketing Authority for the whole EU market today and price goes

########################### D O W N ############################

12% now 10%

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!

By my calculation May 28th would be EU decision date. That date, I think, would be 67 days past CHMP decision.

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.

Best of luck with your investments!

yes, very likely

Now I’m curious if Thermo is optimistic about EU approval and OTLK going forward haha (I would assume so if you’re still buying) :)

I think approval is likely, as you said, based on the current unmet medical need. The combo results, although probably not taken into account for MAA appoval, are also very encouraging.

Would be very disheartening if the application is rejected, knowing DCVAX can help so many people.

Anyway, have a great day. I'll stop bothering you lovely OTLK folks with my NWBO nonsense :)

Cheers!

Appreciate it.