They are not on pink sheets. They are on OTC. The same SEC regulations apply here as elsewhere. You really need to keep better informed.

I refer to her as “Bride of HyGro”.

You’re about to go on ignore because you play it both ways pretending you’re just kidding, but harassing. I would suggest you get lost.

No one here is likely paid but shorts.

I am definitely not paid and have no interest or desire to be paid.

It must really upset you that your lack of sophistication is so obvious. You keep posting at me, but I don’t really care.

Well, ordinary investors chatting about their stocks is a reality. Watch Dumb Money.

The unfortunate thing for shorts is we’re all on to you now, and we do our own thing to counter.

If you don’t like it, that’s your problem.

The older personas were not very credible anymore, so, they launder with new ones or ones they’ve used for other drugs and forums. My guess is some have maybe switched sides, still critical but more the “disgruntled and disillusioned” than the full on basher, undermining with concern posts and similar critiques. I think they are starting to think the handwriting is on the wall in terms of likely approval, and now they need to keep the market from too much positivity. Squeezing shares from and discouraging longs tends to be a tactic at this stage also, I believe.

Hi Chiugray, and maybe think about them as range of potential market size as well as potential market cap, not necessarily actual. Obviously much depends on assumptions, execution, ability to deliver DCVax-L and various other factors. But in terms of the opportunity ahead, many want us to presume that based only on brain tumors and the UK, you can’t expect much, and I think just looking at the basic potential says otherwise.

They will try to distract with other arguments as well, no doubt. But the basics are all there for massive growth and opportunity, not even looking beyond to a general cancer vaccine and other opportunities which I think will also come more rapidly than some want to suggest. Not immediately, and clearly the company wants to meet the most obvious and clear demand first, and some doctors will be forward thinking and have patients who want off-label options.

This has major potential and there are people saying it’s a tiny puddle. The market may believe a range of narratives. I just wanted to rationally discuss what I think is potentially reasonable. Some of the numbers may ultimately come in smaller. They might not get as broad a label everywhere for brain tumors maybe? But I suspect the new data, and past decisions by regulators suggest they are likely willing to give the broadest label.

Right now, the way shorts seem to want to keep it down is by not being so uncredible as their old arguments would be at this time, and trying to downplay the opportunity, even if they get approved.

Honestly, agreed on all points Gary. Thought you sounded a little less excited in that previous post but I think I misunderstood. Thanks for the clarification.

Given the potential after the UK approval, I agree that a 30 multiple would be justifiable given the larger markets them just likely ahead.

I wrote this on my phone and kind of quickly and corrected my self as I went along, but let’s not say actual market cap but potential addressable market after all the discounting. I do think the later numbers are reasonable estimates for a potential market cap as well, ultimately and assuming a credible commercial company exists, which likely means deep pockets backing. And it is not a share price estimate as that depends on dilution as well, ultimately.

Surprisingly negative post Gary.

I do not generally put up numbers but I don’t intend to sell for $3 per share either.

So, I am breaking my general rules to put up some numbers that I do not think are unrealistic, to bat about. These are not trillions nor every cancer under the sun. In fact, I think they miss huge categories like recurrent patients and patients from markets beyond the big 4 we have already potentially just ahead.

Let’s consider first the UK.

Market size of the UK, of course I do not necessarily presume all patients could be operated on or be patients getting DCVax-L, though I do think there will be a lot of off-label patients with other cancers who may want to get DCVax-L, if they can, once it is approved.

However, here is what ChatGPT said about the size of the brain tumor market broadly defined as in the new application, in the UK, but it has a hard time coming up with a recurrent patient set of numbers, mainly newly diagnosed:

Then I asked how many get surgery, and it came up with a fairly conservative number and affirmed the 12,000 number again.



So let’s take the 45% number, x 12,300 = 5400 patients.

As I said, I think there will be patients with other tumor types, seeking this treatment. But, let’s presume we have these patients, and a $250,000 price tag for 2 years worth of vaccines.

That is revenue of 1.35 Billion.

I am not for the moment going to try to boil this down further, but let’s say the market cap is reasonably, 15 x that number because the market will know this is a treatment with broad potential, and typically 15 is not an unrealistic number, it could even be higher…

That is $20.25 B market cap. Now if you are a market speculator and you think, if this was approved in the UK, the EU, US, Canada, and various potential treaty countries are not far behind…

Well, you see what can happen.

We did not look at those other countries, but, just the EU, with a larger population and Canada. It did not have numbers so we took the average of the incidence rates for these tumors for the EU and Canada.

First the U.S.:



So we let’s take let’s say 45% of 17,000, and again these are very rough estimates and do not address the recurrent market at all.

So, 7,650 in the U.S.





45% of the EU cases is, 22,274 x .45 =

10,023.3

For Canada: 1,894 x .45 = 852.3

An additional 18,525 patients, beyond the UK in likely immediately addressable markets.

18,525 x 250,000 = $4.631 B

Additional potential market cap:
4.631 B x 15 = $69.5 B

Let’s add the UK from earlier above:

$20.25B + 69.5 B = $89.75B

Potential addressable market, not market cap.

Let’s say, though I think it is short a bit, but let’s say this is the addressable potential market for newly diagnosed brain tumors, excluding recurrent tumors, in the 4 markets where NWBO will initially apply, not including broader global markets, not including off-label or extended label either, though the market might consider those possibilities if it were well informed.

Generally I do not do this and generally speaking, that is a way larger number than I usually come up with when I think about this in the next few years.

Granted not all patients will be reached. Not all patients will have the care that would make this treatment possible. Not all patients will live to get their second year’s dosage or have enough tumor to get more than 3 doses perhaps. We also do know that brain tumor cases are growing.

This number does not include recurrent patients, which is a large number. Nor does it include off-label or extension of label patients that seem likely to me, even if just a small percentage of other tumor types, it could be a substantial number in total.

I agree with people who suggest NWBO seems to be making very little effort to be around for a long time to address or grow even to reach just this market. But I also think you don’t need thousands of people in executive suites to get this market either. The limitations will be growing production and operational personnel fast enough.

I provide these back of the envelope, very crude numbers not to encourage the people saying 1 trillion, nor to address those saying 5 billion. I definitely think the broader market may think it can only address a smaller sized market or the team is not going to be around.

However, on its worst days, with multiple competitors and a limited blood cancer market, with dead patients, no less, my Car-T investments pre-approval were at 4 to 6 billion market caps with 10 billion or so at buyout.

And we know one thing for certain, if approved, NWBO is grossly undervalued.

Nor you can discount those numbers above. Let’s say you want to say, assume true revenue after costs will be 50% of those numbers.

OK, that gets you to $44.87 B.

Then let’s say we want to say even if approved in those markets, they might only reach 50% of those patients.

OK, down to $22.437B

OK, but the market knows there are still very large markets to address, including recurrent cancers, off-label and extended label patients, and other markets beyond the U.S., UK, Canada and the EU.

Reasonable markets do speculate.

With the right partnerships, there is no reason they can’t reach 22B and beyond fairly quickly, if they have the backing and team in place. I think that is a conservative view and of course assumes a broad brain cancer approval. But even then, 22B is very discounted from what the potential could be.

We’re of course not looking ahead to other versions of DCVax either. Not to other “trials”, though I believe they have many patients already from compassionate use and other cases and real world data that could be assembled subsequently, that could more quickly extend the label. To large and small additional oncology indications.

No need to consider other things like viral applications at this time. They’d have way too much on their hands.

I do think the management team would likely step aside, LP would likely stay on as Chairperson of the Board, CEO Emeritus. But I also think they need a large pharma to help fund expansion and validate to markets that do not as of yet understand this opportunity. I could be wrong.

This is not something I typically do, just a crude and rough, back of the envelope discussion to keep things from collapsing into the “I will sell for $1 category of conversation”.

People may challenge the ChatGPT market size estimates. Completely reasonable to do. But I do not think they are hugely off, I discounted them by 50%, and further presumed only 50% of those would be addressable again. So really took 25%. We reduced the revenue by 50%. We still got quite a reasonable number but also recognizing that there are many more addressable patients in the recurrent market, off label and extension of label as well as additional global markets for the baseline patients.

$22B

I think a fair buyout number might be something north of $30B on approval in 4 jurisdictions, which seems highly likely to me, if early, but obviously, some shine would need to be put on here, in terms of the market understanding of this opportunity.

Shorts look to be fading a bit, but can make a comeback. So the reality is, deals and validation tend to work like “protection money”. Despite our beliefs that we are an advanced society, the reality is bandits have found ways to adapt. They don’t so much steal your money on the roadside, they steal in the marketplace, in broad daylight, in everyone’s view, and with the police looking on, but unable to do anything because it looks legit.

We can’t address that manipulative thievery absolutely, and we can’t necessarily claim the full potential of the market immediately, and maybe never. But there will likely be a lot of demand and a strong effort to meet as much of it as possible. And this all speaks to just the potential for brain tumors.

Have fun batting about those hypothetical and very loose, back of the envelope and crude numbers.

I’m not one who puts out future market caps. I do believe the reforms will get DCVax-L treating other cancers far faster than the old dogs around here looking to old rules.

However, has anyone noticed that shorts saying it won’t be approved have been replaced by new ID’s trying to convince people that the market cap can’t go higher than…. But they don’t specify?

I agree there are unrealistic ideas and numbers bandied about. But suddenly all the new negative posters are here mostly to beat on people who have been here for years, and suggest they don’t know anything. Which is amusing.

Seems like there has been a change in the negative sentiment mostly conceding approval, now mainly trying to keep any euphoric rise and optimism tamped down. New ID’s replace the old ones, but some sound like previous posters. And of course the old ID’s make cameos still.

Just saying, there is a whole different conversation focus now, and mostly, though there are a few reminders or minor newbie shorts, the focus is on approval and post approval market cap.

Something has changed.

Just my thoughts Eagle but my pleasure as always, to share. Have a great weekend ahead!

No, just that financial markets and coverage of them and companies in them is very carefully managed by papers and major media to avoid promoting things that may not be reliable. They'd happily promote Dr. Liau and UCLA. But honestly, it seems like Duke is perhaps better at self-promotion than UCLA. There is a lot of noise in the US as well. Many, many companies claiming that they have "The Answer". Media are terrible distinguishing them from one another. They'll tell just about any story. But say "penny stock" and that's a deal killer in terms of certain kinds of reporting. And even then, like I said, you have plenty of companies that are NOT penny stocks and the coverage focuses on the doctors, patients and trial without often mentioning the company names. Science reports are seen differently. But, often it is hard to get the attention of general media. Science media, as I said, will cover. And we saw LOTS of reports in science media about the clinical trial. But those are not general interest media, which means your dad or uncle or mom, aunt or sister is not going to likely hear about it unless they happen to read very narrow science coverage in industry related media typically.

I will note that there was surprisingly less coverage of the Phase 3 JAMA publication in the UK media than the interim results publication. So the US is not unique. I did not see it in Canada, and I'd expect that we'd have heard about German coverage if it had occurred. So the US is not unique. It's just the nature of things. Some stories are too complicated for major media to really parse what is significant and what is not and without approval and more news of patients living long with GBM, you're probably not going to see a lot of curious journalists promoting the story.

Thanks. Was not aware she was so poetic. :)

Well, as I said, some things go over people's heads because they lack the comprehension to really understand things. Is that simple enough? I did not use "big words" like connote.

Stick with Big Pharma investments. These tiny companies and new technologies are not for you. We are just investors talking amongst ourselves. No one wants you to invest or put your money here. Feel free to focus your attention on investments that you think will prosper you.

You don't understand the context of the overall contractual arrangement. You gave a narrow view. People were already aware of the basics, so providing the link to a contract and simplistically making the assumptions you made is not factual, it's a perfect demonstration of the Dunning-Kreuger effect. You think you know things you don't know. You don't appear to have the competence to know the things you don't know. And you're extremely certain that you know everything you need to know, even when you state things in your messages that clearly show you have large pieces of information missing from your understanding.

But the reality is that no one wants you to invest. We discuss our investment amongst ourselves here. This is an obscure board for investors. You've invested in Merck and are interested in MRNA vaccines. This is not the place for you. So now there is no explanation for why you are expending so much energy and time harassing NWBO investors about their investment decision. Usually there is a real motive behind such behavior. Typically, when one has shorted and is insecure about the short position, one might spend a lot of time harassing investors because that is the only way to try to make one's bet go the way one might want it to go, perhaps. And look, I'm not saying that harassment doesn't work. I think it does. But it's crooked. And in a case like this, it's disgusting, unethical and immoral. But that typically doesnt' discourage shorts. They can pretend to be moral and it seems to allow them to do immoral thins and feel OK about it because their pretensions feel very compelling to them. But as we know also, some of them have engaged in illegal activity.

Good for you. Those are already established companies and technologies. Not a hugely adventurous investment, but then you have no reason to be ghosting around here trying to harass NWBO investors now do you?

You definitely don't post factually. You post partial facts, partial stories in some very few cases. Mostly it's all opinion.

If you don't know what happened, how can you claim you post factually?

It was lifted, Bride of Hygro. Regulators have to be careful disclosing too much and spoiling a trial inadvertently, twice in a situation like this one. So, you can presume whatever you want. But that seems to me to be the most likely answer given all the details. You're not a big detail person. So it's doubtful you could get to any kind of rational determination beyond your own initial and immediate opinion.

You think "connote" is a big word? OK.

You know, it's only 7 letters...

It was not a "Halt", it was a partial halt, and not for safety. Likely for the fact that crossover was so broad, likely owing to the fact that patients saw the treatment as very successful for their peers, that there was no longer a placebo arm and enrolling new placebo patients would be unethical. That would not prevent a trial from proceeding on to approval from any regulator, and especially not when a regular wanted the crossover to address risks that turned out to be non-existent.

You know that giggles don't somehow connote that you actually know what you're talking about. More likely the opposite.

Dunning-Kreuger syndrome is a profound thing.

Yeah, it's a pretty hard and fast rule. Even if you're not one, they often won't say the name of a company related to a breakthrough drug. You'll see stories about the trial and doctors and they might slip in the name, very circuitiously somewhere in the article at best. It might not appear at all. The journalists see it all as pure science, not commerce and when it comes to tiny penny stocks, their entire mindset has been filtered by old news not contemporary news, which is why hedge funds have such an advantage in knocking companies down, putting them on the OTC and then messing with them. It's a very imperfect market.

Too much ignorant BS in your posts.

Approval is likely, the cost and benefit are very favorable at that rate.

The company will be well positioned to advance the treatment and reduce their costs as well. They are well positioned. The discussions I have had with AI, based on the most recent results with combinations, suggests that they would qualify yes, for premium pricing even in the UK. So their current pricing fits well within that range, but I know that they may want to make it less expensive. My suggestion is that they maintain a reasonable comparative price to where they are now or above, for patients who are covered, so that they can provide lower prices to patients who need treatment and do not have coverage. They need to ensure that the company is on solid financial grounds before they can pursue their best impulses.

I hear you. Unfortunately, US mainstream media has a general policy to ignore penny stock breakthroughs. Limited science publications are not necessarily so limited.

Likely you'll see it in the news when there is a deal with Big Pharma, or there is news for UCLA's work on the vaccine. They won't cover NWBO unless it is no longer a penny stock, generally speaking.

$150,000 Initially, for manual production and for the second year can be either 50,000 or 100,000 additional, depending upon dose production. For 1 or 2 additional doses it is 50,000 and for 3 or more additional doses, it is 100,000. Total, $250,000. And depending on the number of doses produced, and assuming biannual shots, that can potentially last more than the second year. I would presume that they could produce no more doses, and they could produce another 6 doses. So doctors will want to get as much tumor as possible to save their patients costs.

$250,000. That puts them around $10, 416.66 per month. That is much cheaper than, for instance, Optune, at $21,000 per month. Other immunotherapies can also be more expensive per month. I did not include VAT for Optune. 21,000 x 12 = $252,000 + $50,400 for VAT = 302,400 per year out of pocket.

Looks like VAT (tax) is around $30,000, or 20%. I presume that is when it is out of pocket only.

Assuming DCVax-L extends survival and costs less per month by. substantial amount, it would be hard to believe a regulator would not think this is an advance over current other treatments.

Ohhh, thank you. Obviously acting on our behalf spreading your fake FUD.

There are no crickets here.

Learningcurve has responded to my response to his harangues and then “ignored” me so that I can’t respond to his response, which is so typical of a frightened short who cannot argue the issues and doesn’t want to keep discussion going for fear of losing the argument.

Well, then ignore the facts if you must and hide your head in the sand by repeating this falsehood.

I gave you the recent UCLA press release clearly indicating they are in fact the same. There are numerous posts with all the details as they were confirmed repeatedly by UCLA, numerous persons involved intimately including Dr. Liau, multiple times, the title of the Phase 3 JAMA article and countless other times.

But if you want to keep pretending longer so that your farce can continue, that’s up to you.

You have no idea what you’re talking about and can’t even point to the patents you’re trying to suggest are problematic. Bluffing won’t do. Sorry. You’ll just have to keep faking it.

Excellent post by Hoffmann, though generally I would not go off of a case for those timelines, even given the letters. But I think the timeline is reasonable in terms of the way he laid it out. You can derive much information from case filings though. As for the timing, the challenge is ultimately that the variables are so flexible, so it can happen even very rapidly if the regulator is very satisfied with the application. It is very reasonable to expect a decision this year.

It is clear though that the Phase 1 assessment can go as long as 80 days or even be faster… it is “up to” 80 days. If there are substantial questions and I do think those types of questions tend to be, then the clock off period might likely take the full 60 days or close to it, but that also can be shorter, or longer if it requires that, but I think more likely around 60, to ensure thoroughness of a response. Such things do not necessarily turn around fast when so much is riding on the answer and not missing anything. And of course, that period might not happen at all, further making it very difficult to estimate. The regulator could be very satisfied with the application package.

Then you have 150 days minus the time for phase 1 (and the clock off period), for the last phase. That is somewhat of an indeterminate period, not in maximum length but speed. Assuming it takes the full period, as he suggests, you look at these variables and you can really get a wide range of decision dates. As H suggests in his staggered timelines.

The initial validation generally happens though, as I said previously, during the pre-submission process using the MHRA’s systems. It is basically presumed valid unless they find something glaring and that Phase 1 period is when most questions are going to come up, so I expect anything reasonable would come during that part of the process in reality.

Here are some further relevant sources:

https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines



https://www.lightning.health/news/guidance-for-new-marketing-authorisation-assessment-routes-in-the-uk-following-brexit-150-day-national-procedure/


People may find those sources most interesting.

No, they do not mean the same thing. Off label means not approved, but prescribed by a doctor. Extended label means an official decision by the regulator to add additional indications for a drug.

You’re revealing a profound lack of knowledge, maybe this is not a good investment for you. You really can’t evaluate an investment if basic concepts sound like “word salad” and you are too impatient to do careful due diligence.

As for the investment thesis, my point to you was that under newer laws, regulations and guidance IN the U.S., and other countries, access to new treatments and drugs earlier in the past has been a focus of change. Therefore looking back over 20 years, isn’t going to be fully informative.

But if you prefer to only look backward, that’s a perfectly good way to make decisions. I am not here to tell you to invest here or anywhere else and given your responses, I really don’t think this is for you. You really have to be able to do basic confirmation of basic ideas and facts yourself. You clearly can’t do that. Neither can the other young lady here earlier. These kinds of investments are not really ideal for most people. Try an index. Get a financial advisor. They would not put you in anything like this anyway, just to avoid liability. Investments should be understandable for you or you won’t be able to manage the ups and downs and if you can’t manage those and decide rationally what to do (buy low, sell high, which seems easy, but most people do the opposite even in blue chips), then highly volatile, early stage and risky companies like this are definitely not right.

We are discussing basic recent regulatory efforts and reforms widely discussed in this sector. But you seem unaware and dismissive. So really, try another option.

My meeting got canceled but I am not in a position to post more than snappy posts. I hate doing serious posts by phone. No, there is a good basis. I believe it gets referenced here regularly.

You are definitely not believable. You can’t even look up and prove basic details.

That’s all you know huh? Not surprised.

Untrue. But All of that to get back to the standard false argument? Sounds like you’ve been here under another name.

Feel free to give that list of patents by Dr. Liau, as inventor, and we can unconfuse you.

Since you can’t seem to look up patents, it’s pretty much a waste of time with you.

I don’t have time for you at the moment. The term “vaccine” is useful here but also not, it is a therapeutic treatment like any other, not preventative.

Yes, doctors can give you “off-label” prescriptions. I did not say “off-label” in said extend label. Big difference.

You have to use the right terminology. Extend label, meaning you get to utilize it and get insurance and Medicare coverage and whatever other insurance coverage you want.

But I am not here to debate with you and don’t have time to give you the full info, so I will leave you wanting more… or someone else can answer if they feel like it.

You don’t patent a trial. Dr. Liau would not be on NWBO’s SAB. NWBO is not a sponsor, but the drug used in that trial is DCVax-L.

https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers

You are a big? Don’t be so hard on yourself.