Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
With median survival over 52 months perhaps the real question should be, how long are those who've survived to 52 months living. Are many of them alive, perhaps even considered cancer free at this time. Are these people continuing to be tracked?
I would suspect that many who live that long will continue to do so, but I'd love to see data that substantiated my beliefs. If that's not the case, clearly there is a lot more work to do.
Dr. Liau's goal is cures for all, she'll continue working to do so. I expect DCVax-L to be part of the answer, but it will take the addition of more than Poly-ICLC to achieve her goal.
Gary
You are right on the money. Suggesting moderators sticky this post.
Gary
I am still of the belief that BP'S will do very well in their future if DCVAX-L plus is curing many patients who otherwise will die, even if they aren't part of the plus.
The only reason BP'S would consider fighting NWBO is if they have a competitive product also approaching approval.
Gary
Something we all should realize is that there is no cheap way of treating a really deadly cancer. Whether a cure is achieved, or not, millions may be spent, or at least billed, in the course of treating the patient. If a product is approved and is the only one that may be of benefit to a patient, insurance will be forced to pay. What they'll pay may very well be far less than the billing price, or the list price of the specific drug, but the patient will be treated.
If NWBO never discovered FlaskWorks, and no one else came along and suggested an automated way of making the vaccine, they still could have been very profitable. Their cost would be higher, they'd employ many more people, but the demand for the vaccine would have been just as great and they, or someone, would have built the tens of thousands of tiny cleanrooms needed to make it happen.
DNDN didn't fail for lack of the ability to make Provenge, they failed because it simply wasn't that superior to other therapies for a form of cancer that's often cured or well controlled. That's very different from GBM and perhaps other cancers, like Pancreatic, where anecdotally some success has been seen.
The pricing of DCVax-L will have far more to do with the cost of developing it than the cost of actually making it. Sure, manufacturing will be a consideration, but if most therapeutics were priced at a reasonable multiple of what they cost to make, with no consideration of what they cost to develop, we'd be paying a tiny fraction of what's actually being paid.
To my knowledge, treatment with DCVax-L and other therapeutics that may be utilized with it, will not require hospitalization, and I suspect can be administered in many oncologists offices, not requiring a hospital at all. Of course that's not true of the surgery required to obtain the tumor, but even there I'm uncertain if substantial time in the hospital will be required.
In my treatment for leukemia, I had several courses of chemo that required extensive time in the hospital. That hospital time very probably added far more to the cost than the therapeutics I was being treated with, though the list prices were substantial. I believe the insurance, Medicare, etc. did settle the bill for substantially less than the list price. On very few occasions my Drs. did have to speak with the insurance company to get therapeutics not tested for my disease, they always got what they wanted, and it was covered. In reality, all sorts of therapeutics are routinely used off label because they're known to do the job. BP's etc. don't try to run trials on everything their products can be effective for. They can't advertise the benefits, but Drs. everywhere learn what works from one another.
DCVax's will be seen to work, demand should be huge as long as it can be met, the revenue produced will be huge as well. We just need to get the EDEN approved and have good sources for manufacturing the units and disposable cassettes.
Gary
Great post, I suggest the moderators sticky this post.
Gary
Smitty, I suspect if you asked those that we refer to as The Street about NWBO over 99.9% would say they never heard of it. That situation is about to change with approval from the UK.
Think of the difference if only 90% have never of NWBO after the announcement. Don't get me wrong, if we were to get major media attention by far the greater majority of the Street would have heard of NWBO, but if we get minimal attention, the numbers who become aware of NWBO will probably expand by a factor of 100 or more.
Not all who become aware of NWBO will, or can invest in it. Many won't invest in OTC stocks or stocks selling for less than a few dollars, but while they'll not invest, they'll be tracking it. They'll become investors as NWBO rises to meet their investment criteria's.
To me, if media discussion discusses anything like DCVax-L potentially being a new paradigm in the treatment of cancer we've hit the jackpot, but I have no idea if at first it will go that far.
I'm frankly unsure just how big a splash the company wants to make with UK approval. If they make a really big splash, they cannot possibly deliver product to those in need. Even if all these people flocked to England where it is approved, the couldn't possibly deliver it.
I don't know if this would be a reason to keep it low key, but without the EDEN I still believe they'll be hard pressed to keep up with British demand for their own citizens who qualify.
I frankly can't say if putting pressure on the regulators will speed approval of the EDEN, or perhaps slow it as the regulators don't like being seen to be caving in to pressure.
For those who followed DNDN years ago, the pressure being applied by investors was immense. They were going to Congress, to the Supreme Court, etc. I frankly believe it may have hurt the company, rather than helping it, but we'll really never know.
I hope we'll never act in the way DNDN investors did. I believe the company has well built plans for achieving approvals worldwide. It is dependent on approval of the EDEN unit and it's my hope that the company is further along than most give it credit for, but I certainly don't know it's the case. Hopefully after the UK approval we'll start to get guidance on many other issues over time, LP at the Annual Meeting said much will be happening over the next 18 months, that's by the end of 2025.
Gary
As I understand it, whether manual or EDEN it takes just under 8 days to make the vaccine. Some believe the EDEN may be optimized to do it quicker, but I'm not aware if that's the case, and if it is, how much quicker. Best to figure roughly 50 batches a year from each tiny cleanroom or each EDEN.
I certainly don't know, but if excess material exists for patients who're no longer with us, but for whom DCVax-L has been made, I'd hope they could use the excess material and make DCVax-L in the EDEN for comparison purposes. I don't know that's possible, but if it is I would hope a decision on the EDEN could be made rapidly.
Gary
I agree with you there completely Kab. I just believe that trials using the EDEN can be permitted before full approval come, at that could be just a couple months from now.
I have no idea if LP is looking to surprise us all by having the Brits examine the EDEN at the same time they're evaluating everything else. Not saying this is the case, just looking at possibilities and why a 150 plus perhaps 60 day process has taken over 250 days, and counting. I feel over 99% certain we'll get an approval, it's possible that it will be conditioned on further trials, but hopefully they'll permit the use of other therapeutics, like Poly-ICLC, which better than triples the 5 year survival seen in the Phase 3 without it.
Gary
I've watched and sometimes been invested in biotech's whose price fell after approval, it could happen here, but not at these prices. If by the time we actually have approval our market cap is in the $2 billion or greater area, then being down post approval is possible, but if approval comes at anywhere near the current price we should rise to something over a billion after approval. I could be substantially more if media coverage is very positive, but if not, over a billions should be a certainty.
Gary
Buy the rumor and sell the news may be a good strategy for traders, especially day traders, but while prices sometimes do come down after the news, the long term investor is often well rewarded for holding and allowing the share price to grow. There is a great deal of good news that can be anticipated over time after initial approval, it comes over many months or a few years, but as approvals grow it leads to revenue growth, ultimately earnings will dictate the price warranted by the stock.
It's my belief that NWBO on the strength of GBM alone with worldwide approvals will be earning billions. No telling how high up is if ultimately the DCVax's are used on multiple solid cancers. With growing revenue for the foreseeable future, I believe NWBO will warrant a P/E of 30, or perhaps even more. If earnings were $2 billion that would give a market cap of $60 billion, if we had 1.5 billion shares outstanding at that time that's a $40 share price. I don't believe it will take that long, but if it took to the end of this decade to get there would anyone object to well over a one hundred banger by then.
Of course anything is possible between now and then, a buyout ends it all, equity partnerships may boost the price farther, faster, but if NWBO's only partnerships are for running trials where the DCVax's are combined with others products the growth can still be phenomenal. Does that mean, don't sell a share, certainly not, sell shares, options, whatever you wish, if you sell out completely I'll wish you well with what you do with the funds. Personally I'm looking forward to when NWBO's at or near double digits and options are available, I'll be looking to make pocket change perhaps approaching six figures annually from selling out of the money calls on a small percentage of my shares. I don't mind getting interest from some of the shares being borrowed, I really don't believe they're at risk and as the share price rises, this too could bring in tens of thousands or more annually.
Gary
Kab, I believe that new trials could be initiated utilizing the EDEN after some initial testing that was successful, but before full approval was granted for commercial production. It's hard to know if the company has advanced it to this point already, but I believe by late this year or early next they'll be able to initiate new trials utilizing the EDEN.
Gary
Sadly, it seems like much of the optimism that proceeded the merger has faded into pessimism. I still believe that the jury is out. Perhaps everything will be very different once we get a quarterly report or two.
Gary
I don't believe that they are dependent on the lawsuit, but if they achieve a major settlement, it might preclude the immediate need for other fundraising activities.
It's my belief that the MM'S won't want to open their records, so a settlement could come quickly once the judge dismisses their MTD. If not, once the records are open, the SEC may want to take a peek as well.
Gary
Flipper, what I have seen normally covers weeks in the UK releases but shows the day the actual approval occurred. I feel pretty confident that the company is notified then, or very shortly thereafter, and is free to announce once they are officially notified.
Gary
It should be clear to everyone that real, official news should only come from the company. That's not to say that a leak can't come from somewhere else, but while a leak may be correct, it isn't official. There may be exceptions.
If the company is notified of a decision and plans a proper PR response in say 3 days, they may fail to know that the agency notifying them does a public release one, or two days after the company has been notified, then you have something official from a Govt. agency.
I would hope that by this time the company has already fully prepared for announcing the UK decision and would do so almost immediately after receiving it themselves. Market wisdom may say hold for Monday, if they received the notification late in a week, but in doing so they need to know the Govt. agency won't spoil their plans by releasing when they plan to release, before the company. On more than one occasion the company has been surprised by regulatory releases.
Good news is good news, even if it's released on a Friday, but clearly stock brokers like good news early in the week so they can work with their clients while it's still considered news. It's not considered news the week after the release, even when the release is late in the prior week.
Today I believe there are very few brokers working with clients regarding NWBO. I suspect that could change rapidly on UK approval, if it gets substantial media attention. If it fails to get such attention, the growth in brokers and Institutional clients will be slower, but ultimately more will be known, approvals will occur in many countries, and Institutional holdings in NWBO will grow dramatically. I would be surprised if by the end of 2025 the Institutional holdings of NWBO don't exceed 25%, something over 300 million shares, perhaps more if the company does a major offering to bring in billions of dollars. Otherwise, many of those shares will be from people right here who've taken nice profits and lessened, or eliminated their positions.
I believe what LP said at the Annual Meeting, in the next 18 months we'll be seeing a great deal of news from NWBO. That 18 months takes us to the end of 2025, it won't happen all at once, but by that time this should be a very different company and many of us should have made millions in our investment accounts.
Gary
Dstock, there is no doubt that BP's have developed massive vaccine production facilities. They however are intended to produce millions of vials of the very same vaccine as they develop vaccines for dealing with the latest Covid, flu, or other variant, or new disease. While they no doubt are in massive cleanrooms which could support many EDEN units, that's not what they've been built for, nor what they're intended for.
Our vaccine is a very different product, each vial is intended for one, and only one patient. Each must be stored cryogenically until its needed for a single dosage. It's very different from what's intended for these massive facilities intended to produce millions of vials of the very same vaccine.
Gary
Stock, I understand that POLY-ICLC has approval in some indication. That is all that is needed to make it commercially. The question may be, how much capacity do they have, and if not sufficient, how long will it take to add substantially more.
Gary
Anything is possible, I would say that the odds of approval are over 99%. I say this in the belief that the UK is like the FDA. If they were going to say no, they would do it in a timely way and say what more was needed. A yes may come with conditions that are being discussed and developed.
I have no idea if they are attempting to include the EDEN in the approval, but if they are, it would be with NWBO acceptance of the additional time required to do so.
For all we know, the decision may already have been made, but it is not official until it's announced by the UK.
Gary
They could contract for practically every function that must be done. After approvals everywhere the contractors would do very well in servicing NWBO, and NWBO would gain revenue from every batch of DCVax-L their contractors were making, storing, distributing, etc. A massive sales effort really shouldn't be necessary as informed oncologists should make no other choice.
In short, NWBO would grow a little, but not nearly as much as some here indicate because that work would be done by their contractors.
Gary
If as we believe DCVax-L when combined with Poly-ICLC or other therapeutics offers 5 year survival of 50% or more, why would patients and/or their Drs. choose other therapeutics.
Is there anything else in the clinic that's shown anything close to this with, or without, combining with other therapeutics.
Gary
I'm certainly no expert, college was 60 years ago, but in biology at that time, brain capacity was related to brain folds, and as we aged it was generally believed we lost folds. I don't know if this continues to be part of the thinking about our brains. If it is, I'm wondering if our drug in some way reduces the rate of brain unfolding.
If that was actually the case, the next logical question would be, would we all be smart to take a small amount of our drug from a certain age. I don't know if it will ever come down to this, but I suspect it could be like aspirin for the brain. Aspirin's been around for over a century and they still routinely find benefits, they can't explain all it's benefits, but knows it has them.
Gary
As someone who's never worked in the biotech industry or had anything to do with regulatory approval I think we ought to thank the bashers who define all the things NWBO needs to do to be successful on gaining approval. Now I've been an investor in other companies that gained approvals, and I believe they too did all these things, and funny thing, I never heard about them.
Aren't we lucky to have the bashers telling us all the things NWBO should be doing, and questioning the fact that they've not done them, because they've not issued PR's saying they've done them. Of course the funny thing is the other companies never did such PR's, but don't be concerned about that, NWBO should do it. The fact that they don't do what other companies don't do is meaningless, NWBO is expected to do it by the bashers, and clearly the fact that they haven't PR'd it means it hasn't been, or isn't being, done. Thank you bashers.
Gary
If all you say is true, but eventually the company get the Journal, gets the regulatory approval, gains blockbuster sales, don't you think we'll have tremendous success then. In reality he's positioned the company for that in spite of all the shortcomings he may have.
He's not the one holding up the Journal, nor is he preparing the application for approval, he's got a team of people working on these things. If the team he's put together get the job done, it really won't matter who's name appears when you look at the CEO.
Gary
I think most here know that I have a few other biotech investments. In those stocks I see a great variety of management styles, possibly dictated by the share price. In those priced at $5 or more I find that they're making appearances at practically every brokerage conference, yet the share prices are down. In one case they have approved products and growing sales, in another good late stage trial results, but not spectacular. In all cases, many shareholders are unhappy with management.
My point is, all these stocks, and the presentations, are essentially recycled, virtually nothing new of substance is being added. Don't get me wrong, the potential of something new being added is there, it just hasn't come to pass. In one case they're promising to file with the EUA as well as a Journal article on their completed Phase 3 trial. In another they're waiting a Congressional bill that should boost sales. Finally here in NWBO we're waiting UK action, as well as the action of a Judge.
My point is management is heavily criticized, in spite of making presentations, because they're simply not generating any news worthy of notice and the stocks just churn, and generally slowly move down. In almost every case some investors are advocating replacing the CEO. It's like if you replaced the CEO a Journal article would come quicker, or an application for approval can be done faster, or a regulator will decide quicker because of a new CEO.
The reality is, the CEO really plays a small part in any of this happening. The CEO's there to achieve the survival and long term growth of the company. Yes, you want them to be a good spokesman for the company, but there is really little they can do themselves. If they're doing their job well, they've put together a team or personnel, or perhaps contractors, who'll get the job done. If you change CEO's you frankly risk loosing some of these key people. I don't care how successful the CEO was in a prior company, it doesn't assure success, especially if the key people largely supported the replaced CEO.
I'm not saying that if someone else were running this company, or any of the others years ago things might not be different today. In some cases we might be ahead of where we are, in others we might be belly up. The point is, at this point the CEO's have us approaching success, I believe they should be allowed to finish what they've put in place.
I'm not suggesting a CEO should never be replaced, but in most cases the CEO either wants to be replaced, or at least recognizes their shortcomings and agrees it would be best for the company and works to get the support of the move from the other key people in the company. I don't believe that's currently the case in the companies I'm discussing, but it could be in the future.
As for the criticism of LP not telling the company story enough, let's see what happens when we gain an approval and a share price worthy of being invited to speak at the appropriate brokerage and Institutional conferences.
Gary
Yesterday I posted about whether we'd move up at the close, on FOMO, or not because the MM's were maintaining their control. Clearly FOMO wasn't present, so good news isn't anticipated on Monday. Of course that doesn't mean it won't happen, but it's not anticipated.
Technicians normally believe that they can anticipate major news looking at the trading before it. The feeling is someone knows what's about to happen and it will be leaked to enough people that you'll see it in the trading pattern in the time prior to its announcement.
I frankly don't believe this is true in every case, but in general it is. I frankly don't know if the UK will let anything slip, nor do I know if the court system will reveal anything before the Judge's rule, but technicians generally think something will be apparent in looking at the trading before either of these events are announced.
Of course there are other things that could happen, no telling what LG may say if he does make another appearance on the Big Biz Show. Perhaps even a new article by Smith on Stocks could spur some small move. The question is if anyone knows, and reacts, to what may be coming tomorrow.
Gary
Zadie, if we see new trials scheduled it's my belief that they'll be done with the EDEN, with or without full approval to use the EDEN in commercial production. I believe this is possible as trial product does not have to be at a level that's approved for commercial production.
I would suspect that new trials won't be found until we have the UK approval, but shortly after that we may find the IND's are filed for them. It's hard to say if any will actually be initiated this year, it does take quite awhile to initiate a trial after the initial filing has been made.
Gary
I'm of the belief that after UK approval the share price that's obtained will have far more to do with the picture the mass media presents than how quickly it's anticipated that revenue will build.
If the media simply says, DCVax-L has been approved for GBM in the UK. That's where $1 to $3 of so is likely. On the other hand if a picture is painted of a new paradigm in the treatment of cancer, if the potential to treat nearly all solid tumors is emphasized, and if worldwide acceptance is anticipated in a couple years, then no telling how high the share price may be taken, or where it will stabilize.
I have no idea what direction the mass media will take, I don't know if the company has been feeding information to the mass media on the potential of DCVax-L. Frankly I don't know if the company wants to put themselves under the microscope that a great deal of publicity will bring, or if they'd rather keep growing under the radar until they have EDEN acceptance and international approval, and the mass media has truly recognized how great the potential is here.
Gary
A few decades ago the Las Vegas Casino's fought the building of Indian Casino's all over the country, they felt certain it would diminish travel to Vegas. Over time they learned that just the opposite occurred, people playing in Indian Casino's became more attracted to going to the homeland for casinos, all the choices, the many shows, etc. Vegas grew far faster than prior to Indian Casino's opening all over the place.
I believe that much the same will occur with DCVax-L. Certainly, some BP's will find that certain of their products are no longer selling, but they'll also find that others, those that work with it are selling more. Perhaps most importantly, they'll find that more people are living and those people will buy many of the other products those companies make that aren't in any way associated with cancer.
Nearly all the BP's have all sorts of products, oncology is just a small part of the total. Many make non-prescription products we use daily. Survivors will continue to use all these products. In the beginning some BP's may not feel this way, but in time they'll see personalized products for cancer, or other deadly or debilitating diseases that permit people to live normal lives will result in them using more of their products.
I'm not suggesting that BP's may not want to own all, or part, of companies developing personalized products. I do believe that personalized products won't integrate well with mass produced products, a personalized product division of a BP should not be integrated into their mass produced products, they should operate independently.
Gary
The average daily volume will probably go up by a factor of 10 or more once we have an approval. Today, I doubt if .1% of the investment public have ever heard of NWBO. I can't say how much publicity we'll get on UK approval, if it's poor, I suspect 10% of the investment public will have heard of NWBO, if it's good 50% will have heard of us. If we get great publicity, if DCVax-L is heralded as potentially a new paradigm in the treatment of solid cancer, virtually all the investment public will have heard of us.
This won't make that investment public into investors, some still won't consider investing until the share price is $5 or more, still others won't invest until it's off the OTC regardless of it's price. I'm not concerned about those people, eventually they may consider investing. I believe that once UK approval occurs we'll gain a substantial number of new investors and the higher the price goes, the greater the percentage of new investors go.
I frankly don't believe the MM's will be able to control the price as the demand will be so high, but of course I may be wrong. The MM's have had amazing control of the share price recently, I just don't believe they can keep it as the investment world learns of our investment.
Gary
I don't believe that you will see a fast decline because I think that the company will have more to say rather routinely after approval.
As for today, the question is, does FOMO kick in toward the end of the day, or do the MM's work to lower at the close.
Gary
NWBO is only in control until they submit to a regulator. After that, they are at the mercy of the regulator.
Gary
Is something wrong with the site. I can read and post on my phone, but get page unresponsive on the computer. Only appears to be happening on the NWBO board.
Gary
Just add real news.
I've only seen it a few times in my life where a stock is up ten or more times in minutes, but with the right news, we have that potential.
Gary
A poster, I forget who, alleged that had the trial been run in a different cancer approval could have been obtained faster.
As I understand it, Dr. Liau collaborated with NWBO in creating a vaccine for fighting GBM. With all the preclinical work based on GBM, I'd like to know the thinking about how a different target could have achieved approval faster.
It's my belief that if you do the preclinical work on one cancer, if you wish to do a trial on a different cancer, you have to do the preclinical work, which takes years, to justify the submission of an IND on that cancer.
Gary
Bas, I agree, I was just trying to hit the highlights of what the bashers had to say, and how wrong they've been over the years. I suspect that there are at least a few different organizations or people who're funding their efforts.
I would also suspect that a few of the bashers are shorts themselves who're pushing their own agenda.
Gary
This is a great posts that summarizes all that's happening with NWBO. I hope the board moderators will sticky this post.
Gary
We need to learn from the bashers. When I first invested in the company the trial was underway and the bashers were saying they'd never complete it. Then before it completed they said the regulators will never accept all the changes. Then it completed and they said no credible Journal will publish the findings. Then they published the finding in JAMA and they said they'll never file with a regulator. Then they filed with the UK and they said it wouldn't be accepted. Then the UK accepted and they're saying they won't approve.
Finally they're telling us that with approval no one will pay for the vaccine and the company will simply go broke on no sales.
It's simple to see how right the bashers have been and fully respect the brilliance of their posts.
Gary
I believe that after approval there is a misconception that we'll be competing with BP's in the near term. I believe it will be just the opposite of that, BP's will be working to show that their products enhance the performance of DCVax-L.
We know that Poly-ICLC and Keytruda have seen efficacy improvement that's substantial in GBM. We really don't know that much about other cancers, or which product in which cancer can maximize benefits.
My point is, none of the BP's are making a personalized product like DCVax-L and frankly I believe if they want to get into that business, they'll look to either partner, or acquire NWBO. Meanwhile, the emphasis will be determining if their products will produce benefits with the vaccine.
Our vaccine represents a new paradigm in the treatment of cancer, but by itself it's not the answer. The key will be the vaccine plus, and that plus may be one, or a combination of other therapeutics that ultimately cure the cancer. Ideally like DCVax-L the other therapeutics ideally will be easily tolerated making cancer treatment far less painful, but the key is achieving a cure.
From what I've seen it's the explosion in the T-cell population at the cancer that's the key, the therapeutics that provide the greatest benefits could work by making the patients T-cells work better in killing the cancer. My laymen's view, I'm sure that there are better ways of expressing it, but let's get that initial approval and watch what happens.
Gary
The question in my mind is, if we get a major short squeeze, does it raise the future range we are trading in.
Gary
I really believe MRK would rather have a partnership with a substantial equity position than buyout the company. If they were to buyout the company it ought to operate as a wholly owned subsidiary as it's operation is so different from everything else they're doing.
Gary