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Thanks Antihama,
There are a lot of people who're making this sound far more difficult than you're saying. Is it possible that it will be much tougher to gain approval in the US than the UK, or if we have UK approval and it's proven to be working in patients should it be accepted on that basis.
Gary
Doc Lee, I'm in agreement with you and previously said so, however, I'm wondering if our technology could be used to build new high production vaccines faster. When new strains of viruses like covid are detected, could we process a number of patients to create multiple vaccines that are combined and then duplicated in mass in a bioreactor. I'm certainly no expert at it, but I gather that there are bioreactors that can duplicate what is inserted into them. If that's the case, for an individual running out of vaccine it would be possible to create more in such a device as long as sufficient vaccine existed to do so, that would potentially provide a limitless supply of vaccines like DCVax-L if needed.
If that's true, and if we could develop a vaccine for a new threat, like covid is, with new strains developing frequently, if as I suggest we could combine many patients vaccine and then duplicate it in a bioreactor, with adequate bioreactors we could mass produce vaccines against the newest strains in a matter of a couple months, or less. I don't know that this is practical as I don't know if a problem could result from something a patient provided that wasn't intended, but just looking at possibilities.
Gary
The question in my mind is, if hydrogen is available very deep, I would suspect it's under immense pressure. Do we release it without replacing it with something, or do we fill the void with something. I would suspect that if we're releasing it and lowering the pressure, are we not setting up for future earthquakes that could be massive. Fracking has certainly resulted in earthquake activity in the area we get the oil from, could removing hydrogen have greater risks. Also, is this hydrogen really pure or must contaminants be removed.
I believe that there are better, and cheaper ways of getting all the hydrogen we want. The key is bringing the cost of doing it down by bringing the cost of the energy to do so down dramatically.
Gary
I'm certainly no expert, but I believe that if a patient's tumor is large enough they can get sufficient lysate to make two separate batches, and leukapheresis to do the same. One batch can be made manually the other in the EDEN and comparisons can be done with the use of tiny amounts of the vaccine from each batch. This would probably be done with patients in the compassionate use program with some advantage to the patient for doing it.
If others care to suggest a better way of doing it, feel free to chime in. To me, the advantage to the patient is having far more vaccine as long as comparisons prove to be positive. As long as sufficient vaccine for normal treatment is achieved from the manually produced effort the patient shouldn't be harmed in any way.
Gary
I think that there are a few things we all need to acknowledge. The EDEN and UK approvals are in no way related, in the UK they have clearly approved commercially manufacturing manually. Sawston will be used in proving the EDEN when the start of the contracted units are delivered, how this will be done hasn't been substantiated, nor is it yet clear if all regulators are involved with the approval of the EDEN at Sawston.
Until we hear of any delay in the approval process in the UK, the 150 day timeframe should be considered intact, that's a decision in May I believe. Many here seem to be anticipating a few months delay, it may happen, however it's equally possible that we'll gain an early approval perhaps as early as late this month.
The suit by Posner is in her court alone, the company may be assisting with some facts, but it's up to her to file this week. If she determines not to do so, the case will have been abandoned by her and the money they've spent taking it this far will be a loss to her company.
I've often speculated that filing for FDA, and perhaps other approvals, is pending acceptance of the EDEN prior to the PDUFA or similar date. This is purely IMHO, if one or more of the regulators believe that Sawston operating manually can meet their production demands their regulatory filings can be made any time the company chooses to do so. I believe the company knows what each of the regulators expect before filing. I also believe that roughly 90% of what's in the UK filing will go to the other regulators, however the commercial manufacturing had been previously approved in the UK, so a manufacturing section will need to be added to all others.
I will also speculate that the Annual Meeting will not be schedule until some action occurs in the UK. If the meeting doesn't occur until mid-year it could constitute a meeting for both 2023 and 2024.
Gary
The only real question here is how much of the company will the owners of Core Optics hold when all the dust settles. I'm of the belief that they'll have the majority, but don't know if it's 60%, 75%, or 90% or more. If they're bringing in major earnings we should still come out fine, though I hope they do it without the R/S as the revenue alone could really build the share price of the stock.
Gary
Biosect,
What I believe that bashers need to know is that as long as the company is advancing toward approvals and acceptance of the EDEN unit, if managements needs more shares to be authorized to do what's planned for the future, shareholders will do so.
I'd prefer they stay away from a reverse split, but frankly if we're to have equity partnerships in the future, I would expect additional shares will be needed to accommodate one or more of them. That's fine with me as I believe they'll drive the share price up, not down, and that's what it's all about.
Gary
I'll certainly agree with that. If you can cure, or greatly benefit patients with the likes of HIV and long term covid, I can see spending substantial money for that vaccine. I really don't know it's possible, but it's worth a try after we've achieved success in cancer.
I believe that over time there will be all sorts of personalized products developed, the EDEN device, or variations of it, may work to create many of them. I believe in time it will be something like a compounding pharmacy that can make some of these products, but they'll start from bodily components much easier to acquire, perhaps blood, saliva, hair, etc.
Gary
If viruses have individual variants, I'd think that you'd want the virus from the patient. I can see the process working, but I still think the cost may prove to be excessive and insurance coverage difficult to get. If the intent is mass distribution I really believe it would need to be simplified. I don't know that it could be done in a compounding pharmacy, I don't think so, but perhaps a simpler form of the EDEN could be built and distributed to hospitals prepared to do this everywhere. A big part of the cost might be eliminated if cryogenic storage of the vaccine wasn't required. I'm not saying this is possible, just questioning the possibilities. My thinking is the total cost of such treatment would need to be no more than $10,000, but I could be wrong, I know that many do die of viruses, but probably not more than 1 in 10,000 who get it. How many patients would opt to get the vaccine while it could still be of benefit when 99.99% will recover without it. Perhaps my numbers are off, but even if it's 1 in 1000 I question it's viability.
It's very different with cancer. The least deadly cancers still probably kill 10% of victims, the worst well over 90%. The point is, a great percentage get benefits with DCVax-L, I don't believe the same can be said for a DCVax-Virus.
Gary
By here I'm assuming you mean the US. As I see it, I believe it would be worth at least an additional $5 in the stock price. The likelihood of it happening I think would be based on a few things, primarily UK approval by June, and a determination by June that the EDEN unit would be approved by October at the latest. I say this because to get a PDUFA date this year their BLA would have to be filed by June at the latest and I don't believe they'd do so without knowing they have UK approval and that their commercial production facility, utilizing the EDEN, could be ready for inspection by November.
I frankly believe the FDA will be a 2025 approval, but 2024 is not yet impossible. I suspect that Europe and Canada could come first, especially if they're satisfied to get manually manufactured product from Sawston to meet their production requirements. Of course everything changes if the EDEN is ready much faster than many of us anticipate.
If Europe and/or Canada were to piggy-back the EU approval, rather than making the company apply separately to them, it would be a real game changer. When the UK was part of the EU I believe that would have been the case, but I believe it would be a stretch today. As for Canada, I believe they still hold the UK in high regard, so anything is possible. I don't believe that there is any chance the FDA wouldn't insist on going through the entire process themselves, even if they're working with all the other regulators through the entire process.
I'm still of the belief that CRL will become the primary CDMO for at least the US once the EDEN has been approved. I think the Memphis facility is designed to accept many EDEN units, and all the other equipment needed to support production is already there and being used for other products today.
Remember I didn't say a $5 price, I said at least an additional $5, if we have UK and EDEN approval prior that easily might take us into double digits, the key will be what precedes the FDA approval.
The key to maintaining growing share price is earnings, I really don't believe it will take that long for us to be bringing in billions. With our technology I really believe that we should warrant a P/E in the 20 to 30 range, With a billion in earnings a P/E of 30 and 1.5 billion shares outstanding we'd warrant a $20 share price. If we don't get there this year, which is doubtful, I believe the odds of getting there next year should be excellent. Just to begin with, I cannot see any patient with operable brain cancer not pushing to get DCVax-L once it's approved and available. Then over time we'll add patients with other solid cancers, off label at first, but ultimately part of the SOC. That may take many years, but it will also bring many dollars.
Gary
Can anyone guess where we'd be if DCVax-L was considered for approval here this year.
https://www.fiercepharma.com/special-reports/top-10-most-anticipated-drug-launches-2024
For the most part they are looking at what they believe anticipated sales will be for the 10 products they've selected in 2028, I believe our sales will be a multiple of their largest by that time.
Gary
I'd like to get some clarification about building a vaccine with our technology on a virus. In cancer, we get the vaccine from the tumor and leukapheresis for DCVax-L and from leukapheresis for DCVax-Direct, but inject into the tumor. Where and how do we get what's made with our process with a virus, and when we get it, where do we put it to be effective.
If we can do it with leukapheresis, and if it can be processed in the EDEN unit, and our vaccine is injected somehow, what sort of price could be applied to such a vaccine.
No doubt a personalized vaccine against a specific virus should be more effective than what it's being treated with today. The question is, such a personalized product will be expensive to make, can it really sell at a price that would make it profitable. I would suspect that the answer may be, only for patients deemed not to be able to survive with existing antivirals, then something with say a six digit price tag may be authorized if we can make it quickly enough to be effective. I don't know if it's really practical.
On the other hand, if our technology can take material from many patients suffering from some new virus and create a vaccine which can be mass produced and injected into millions, that would be a completely different matter. It wouldn't be a truly personalized vaccine, but rather a rapid way to build a vaccine against some new virus mutation that current therapeutics weren't working with. A question then would be, would the regulators accept this vaccine without extensive clinical trials.
Gary
My dreams as you put them are based on the assumptions I include. In this case the assumption is that DCVax-L is accepted to be tumor agnostic and was being applied to many forms of solid cancer. What sort of price do you believe NWBO would have if my assumptions were borne out.
Gary
I don't know if rules have changed regarding quiet periods. I know years ago a company would issue a PR indicating that they're going into a quiet period, I haven't seen any recently and suspect it's no longer required, but I don't know that to be a fact. Back when they were announced you always knew something could be happening, of course not every discussion comes to fruition, so when the company announced something without anything new of substance, you knew the quiet period ended without anything worthy of announcement.
Companies seem to use quiet periods as an excuse not to speak with investors. All they have to infer is that they're in one and they've covered themselves. Likewise companies have periods where executives can buy or sell stock and options, during much of the year they're really prevented from such actions as it would be deemed that they were trading with insider information.
I would hope that the company is waiting to announce acceptance of a regulatory filing, rather than either anticipation by a fixed date or filing where changes may be needed prior to acceptance. NWBO made the mistake of announce when they intended to file, then twice announce delays, they would have been far better not telling investors until at least they'd filed. I hope Avanex doesn't make the same mistake. I'm not speaking about giving general guidance, like we intend to file by third quarter, just not a date certain that's only weeks away.
Gary
Companies generally only discuss technical information that's already been subjected to peer review. If the information you believe they should be discussing hasn't been peer reviewed, but is contained in the Journal being peer reviewed, watch for it to come out once the Journal has been released. I don't know this to be the fact, I'm a new investor in the company, but about the only time a company announces date prior to peer review is when TLD for a trial is released when a trial is concluded and the data consolidated. TLD isn't much more than a paragraph or two summarizing the entire trial, not the specifics investors are looking for.
Peer review can be a Journal or presentation in a major technical conference where an abstract was submitted and the presentation made. After either of these events occur the company can PR results, and/or present them when speaking at Institutional or Brokerage Conferences.
In general, I've found that investors always believe that companies ought to be tooting their horns much more than they do. I believe that both the FDA and SEC don't like such hype and most companies that do it are generally regarded as being scams. Certainly companies on the Pinks can get away with more of it, as almost no regulation is applied there, but that's not true of companies on major exchanges.
Gary
I agree Smitty, but you can bet that any buyout agreement has contingencies that must be achieved before any effort is made to move the stock. For example, if LP and Merck agreed to a buyout at say $30 a share, it could be contingent on approval to use the EDEN unit and the approval of at least say two of the four regulators. If that were achieved and the stock was trading in the $8 to $12 range Merck would work, perhaps through Institutions they have a good relation with, to nudge the share price up to $15 or more, then the buyout would be announced.
The price being paid in the buyout may have been agreed to even now, but clearly it wouldn't happen until certain key things had been achieved, and then they'd assist in reaching a share price where investors in both companies would be satisfied.
I'm not suggesting that LP and anyone else has made such an agreement, only that it's not impossible. I believe that today, with what the company knows about the potential for the DCVax's, that a price of $50 billion for the company would be a bargain, that would be about $30 a share I believe. If all that the company knows is validated by trials and regulatory approvals that price should easily go to well over $100 billion, perhaps even $500 billion, but it would probably take at least a decade or more. I'm speaking of both DCVax products being approved with tumor agnostic labels and use expanded to virtually all the world. Actually that could have the market cap in excess of a trillion.
Frankly I believe that we could get one or more BP's as equity partners and never have a buyout. The partnerships will provide the funds to advance trials with their products that prove our tumor agnostic claims far faster than we can do it ourselves, and the equity they'd get in the partnership would prove very profitable for the BP as the share price goes through the roof. I'd certainly prefer that to a buyout, especially one that forces me to take a huge profit rather than pass the shares on to my daughters and leave some to charity, most likely City of Hope.
Gary
The only reason that the price is driven up is to make themselves look better. They agreed to an acquisition price and they want the stock price to be at least half, and ideally more, than what they agreed to pay.
Gary
If what you're saying is true about Core Optics earning $100 million a month I see no real problem, the only question is, what percentage of the company do they receive when this merger goes through. If it's 50%, if sufficient shares exist to provide them with as many as is currently outstanding, they can receive them. If that many shares don't exist, more could be authorized, or a 1 for 2 or less could be done and they could gain 50% or even more.
My point is that a small reverse split should be the most it takes, if that much, the company is earning over $1 billion a year. The P/E for such a company should be at least 10, and perhaps as high as 30, so the market cap should be somewhere between $10 and $30 billion. Right now there are under 300 million shares outstanding. If the share count were expanded to 600 million with Core Optics taking half the company, the share price with a $10 billion market cap would be over $16. If they took 900 million shares, giving them 75% of the company and taking the total share count to 1.2 billion, with a 10 billion market cap we're still talking about over $8 a share.
The point is if you're correct about how much their earning already, they could take 75% or more of the company and with the additional shares authorized they do not need a reverse split to end up with a share well above $5 and that's with a P/E on the low side of 10. If the value of the potential of their battery technology is added, they could very well justify a P/E of 20 or more. There should be no problem getting say 2 billion shares authorized in a scenario where instantly you have a $10 billion or greater market cap. The Nasdaq should be available as soon as all requirements are met, and a $5 share price or greater should be assured. Of course this is all based on the over $100 million you're saying they're earning a month being true.
Gary
The pinks and OTC stocks are the wild west of the stock market, you'll never see the regulators get into them.
Gary
You're right, it was a typo.
Gary
I know that CAR-T is high risk, I know some leukemia patients have received it successfully when coming out of remissions where nothing else was working. My Dr. said it's not something he ever wanted to have to try on me.
One of the biggest problems with CAR-T, as I understand it from my Dr. is that it's effective lifetime is limited to a number of days, it may get a cure in those days, but if not, it's not the answer. Our vaccine, on the other hand, increases the patient's T-cell count dramatically, they're not modified T-cells, but they just keep working and the numbers keep building as the patient gets additional doses of the vaccine. I believe that this is the key to why our vaccine works, and the addition of certain other therapeutics make it work better.
Gary
City of Hope working on brain cancer with CAR-T, here's a link to info I was sent:
https://www.cityofhope.org/brain-cancer-no-match-immunotherapy-trial?utm_source=sfmc&utm_medium=email&utm_campaign=MKT_NTR_Supporter_Breakthroughs_Valadez_20240307
My Dr. was one of the leaders in CAR-T when it was in its infancy. This is only in Phase 1, but I still believe the more tools a Dr. has, the better. I suspect that DCVax-L + will become the SOC in brain, and many other cancers, but I can't say all that + represents, in some cases it might include the COH CAR-T therapy.
Gary
Where did you find this, I see $.584 as the high of the day.
Gary
I'm purely guessing, but believe that it was DCVax-L given out of the UK compassionate use program, but Dr. Mulholland learning from the work being done at UCLA, etc. used a protocol that differs from anything currently in a trial.
It's clear that the Dr. know all about DCVax-L, he was chosen to make Dr. Liau's presentation at SUNY when Dr. Liau developed Covid in the UK. In general many similar presentations I've seen were not specific about what product was being used. Clearly if it was DCVax-L it would have been out of the UK program as no other trial in the UK was enrolling patients.
Gary
I think a great deal depends on your definition of eminent. For a vaccine that's been in development for decades, I'd say an expected approval in the next 3 to 4 months could be called eminent. Certainly, it's not happening tomorrow, I'd put the odds of happening this month at no more than 10%, but next month could be 40% or higher, by May might be 80% and by June 95% IMHO of course.
The peer reviewed article in Nature may come sooner, or later, if we've learned anything about peer reviewed Journal articles it's that you really can't predict when they'll happen, we just know that it's in peer review.
This is not something that only happens to NWBO, I have a position in AVLX and they too have been holding on for ages for a peer reviewed article, and no investor seems to know what Journal it will appear in. At least we know that Nature is where we'll see the article.
Gary
The goal of going on a major exchange is something we all can agree to, if it's done the right way. The right way is by largely building the share price. The wrong way is a huge reverse split. When the stock was selling for a nickel a 1 for 100 would give you a $5 price if the market cap was maintained, but history says it won't be. In fact I doubt if $4 would hold long enough to get on the Nasdaq. Perhaps a 1 for 200 would make it, but the market cap would be 50% or less than before the reverse split. It's not the right way to do it.
What is the right way, first build the share price to $1 or more, while I'd very much welcome that and would go along with say a 1 for 3, 4, or even 5 to approach the Nasdaq, but frankly if you can get the share price to $1, you could go on the AMEX and continue to build until you're at $4 or more and go for the Nasdaq, or you could just stay on the OTC until you qualify for the Nasdaq with revenue growth. Immediately the revenue might be entirely from Core Optics, but I bought this for it's battery technology, it that's recognized and a major contract comes in, it could be what really moves it to the Nasdaq. It takes patience, but if you do it the quick and dirty way with a major reverse split, you may be on the Nasdaq, but your market cap is a small fraction of what it had been.
I hope the Core Optic people who may be taking control do so in such a way as to build market cap, not tear it down.
Gary
I certainly hope you're right. I've got to believe that current shareholders will have less than 50% of the equity in the company after the merger, but it can be done without an R/S if that's what they choose to do. It could involve preferred shares that don't vest for some time, so they don't exceed the currently authorized shares. The thing is, 50% or less of something good may be better than 100% of something fighting for its very existence.
The other question might be, will anything happen with our battery technology that adds substantial equity before the merger actually occurs. That could dramatically change the way the merger will finally be structured.
Gary
You're right, but something we need to realize is that many cancers take years to kill, or cure, so while in cancers like pancreatic the benefits may be clear quickly, others might take a decade or more to actually determine the benefits. Hopefully Drs. and patients will have choices, if they choose to go with DCVax-L and products like Poly-ICLC and Keytruda, and forgo certain costly chemos, insurance will agree to pay at least what they'd have paid for the SOC.
I'm not suggesting that all chemo can be eliminated, what I believe is the Drs. can make determinations of what they believe will be best for their patients. I expect that in certain cancers different therapeutics will work better than the ones that work in GBM, Drs. will work to determine what works best.
I frankly don't know if, or how much, Dr. Liau and others who worked on the GBM trial will participate with the use of DCVax-L in other none brain related solid cancers. I feel that they should have a voice because of their experiences, but Drs. with expertise in those specific cancers should lead the trials.
When I was initially diagnosed with leukemia, I immediately worked with the oncologist who treated me after I was treated for sebaceous carcinoma found by my dermatologist, and found I had a kidney cancer which was dealt with. He wasn't an expert in leukemia, but started me on the protocol that was suggested for it. It called for eight specific courses of chemo, but after four of them a catheter infection delayed treatment, and during the delay I spoke with the heads of hematology at both UCLA and City of Hope, I was on Gleevec, an oral chemo at that time while the infection was being treated. It was very fortunate, both experts wanted to see how I progressed on the Gleevec and suggested that I might not require the other four rounds of chemo. Both also told me to go for stem cells on achieving remission while my oncologist thought I shouldn't do it, if I came out of remission, he said they'd get me back in then do the stem cells. I was shown that achieving a second remission was often far tougher, and often it didn't happen. Furthermore at three years, if I remember correctly, 70% were coming out of remission, it may have been lower, but it was significant. Had I not had the catheter infection I'd probably have had the additional courses of chemo, instead it was pill chemo, but I switched from Gleevec to two others most of the time before the stem cells. Heavy chemo is done just prior to stem cells as your own immune system has to be wiped out prior to the new stem cells taking over. I had a 12 point match, which is as good as it gets, but I still have issues caused by the donor stem cells, like an allergy to many sun tan lotions.
I bring this up because I'm certain that other experts would have treated me differently and in fact I met a man my age who came to City of Hope because the Mayo Clinic wouldn't do stem cells because of his age. I actually only recently learned that I was one of the first in my 70's to get them at my age at City of Hope, but UCLA and Cedars Sinai both would have offered them. Now City of Hope is doing it for patients in their 80's. The reason hospitals shied away from older patients was thought to be higher mortality numbers, City of Hope has excellent numbers while including us seniors. I continue to be checked by COH roughly quarterly and enjoy my visits with my Dr.
I suspect that in much of the world I'd not have been offered stem cells at all unless I seeked them out myself. My point is that treatment will be very different throughout the world. Even if DCVax-L is readily available some Drs. will only consider using it where labels say it should be used, whereas some may use if in practically every solid cancer case, even if no basis exists for doing so. We keep hearing about people with GBM using other products, one reason is not knowing about it at all, the other is it's unavailability unless you go to the UK and have the funds to acquire it. In most of the world it ought to become the SOC for brain cancers rather quickly after the initial four approvals, as for other cancers it will vary dramatically both based on the country and it's policies on off label treatment, and based on the Dr. and their belief that it can be of benefit to their patient. It will take years before Drs. really know how best to use DCVax's and where they're most, and least effective.
Gary
I'm really lost in all the history, I hope they're doing more than purchasing a shell to go public, but if they're purely in control we'll really have to see how it plays out. I bought the stock for its superior battery technology, if in fact they're not intending to advance that, I really don't know what direction I'd take. I would hope that their core business adds to what we've developed, but the key there is someone committing to utilize our technology in their batteries.
On more than one occasion I've had companies purchased as shells, by the time they finished existing shareholders owned less than 10% of the company and frankly the new company didn't do well for the shareholders. It doesn't mean it can't happen, but it's not what I'd prefer to be happening. If we end up with a small R/S I could live with that, but if it's anywhere near a 100 to 1, which I've seen in other companies, frankly we're screwed.
Hopefully the shares rebound some tomorrow, if not, perhaps when more info is out, but if the word is that a big R/S is coming I question if it can ever be a good investment unless we average down, which I already did today.
In NWBO, many long term investors had bought at $10 or more a decade or more ago. Most have now brought their average price to well below $1 and are positioned for tremendous share price growth beginning with UK approval which should come by mid-year. Personally I've only been involved for a few years and my average is slightly below what it's selling for today. If I'm right, $10 a share and more will have returned by sometime next year, or sooner.
Gary
I hope you are right, it is rare that a R/S works as intended without dramaticly reducing the market cap. I know we are a penny stock today, but one major contract could change that forever. I'd like to see them continue working to get the contract.
Gary
I believe that the way a company doesn't require a vote on a reverse split is if they control 50 percent of the shares themselves or with concurring Institutions. I have no idea if they have that much control.
Gary
Abeta,
Are your figures for the UK only, or the world. If the world, I think they're low.
Frankly if NWBO contracts for all services in manufacturing, storing and supplying the vaccine to each patient I'd be thrilled if the received $100K or even $50K for each patient. That money would be received with virtually almost no money being spent by the company for it. Depending on how the distribution of the EDEN unit is handled, that too could be a major profit center as long as the number of EDEN units was expanding. As I see it, with the adoption of DCVax-L, and ultimately Direct for many forms of solid cancers, demand for the EDEN unit could be great for over a decade or two.
If as I believe the EDEN's are leased and maintained by the company, just lease renewals could be a major profit center as the numbers in use each year grow for the foreseeable future. I'm frankly uncertain if every disposable cassette will pass through the company, or be supplied by St. Gobain's Glass directly to the manufacturing site, but regardless, I'd expect that NWBO would receive something for each cassette that was delivered.
Of course I may be wrong, the company may do everything themselves, the cost would be quite high, but they'd earn more per patient. I just don't believe they're set up to operate in that manner.
At one time, many years ago, IMGN had it's own production facilities. At some point they abandoned that approach, they went with CDMO's, who for all I know purchase the companies facilities. I believe that CRL and Advent are completely set up to perform these function for NWBO once approvals come in. I don't know if UK approval will be sufficient to formalize the CRL agreement, or it will take approval in the US or elsewhere.
I don't know the total population of the world being diagnosed with a solid cancer annually. I believe it's well into the millions. Can you imagine how big we could be if 5% to 10% of all with solid cancer gained treatment with DCVax's. For talking purposes lets say a half million patients a year were having a DCVax made, at 50 batch a year per EDEN, that's 10,000 EDEN's. If they leased for $10,000 a year that would be $100 million a year. I doubt if NWBO would be spending much more than a million or so in maintaining all the units. At a P/E of 10 that's $1 billion added to the market cap. I think these numbers are reasonably conservative, but I welcome others thoughts about them.
Gart
I agree, hopefully the demand will result in at least the UK authorities expediting approval of the EDEN unit, provided NWBO is receiving completed units from their contractor. We know that they do have limited capacity in London. Frankly I don't know if the US would approve a deal that had CRL making the vaccine here and exporting it to the UK before the vaccine is approved by our FDA.
In my mind I'm wondering if any of the European authorities could piggyback off the UK approval without a formal submission. I believe when the UK was part of the EU such a submission would have applied to the entire EU, but I don't know that it was the case. Germany seems most eager to move on using DCVax-L, if individual European countries can approve for only their country, it wouldn't surprise me if Germany was the first.
By the way, I figured that day 90 would be the very earliest that we could be in an approval window, with us at day 78, we'd be less than two weeks away. Not saying it will happen that quickly, just that I can't imagine it happening earlier than that. More likely we go closer to day 150, but I believe it will happen somewhat before then.
Gary
Should the company be able to put the presentation on the website after the conference concludes?
What's really needed to make such presentations work as well as they could is the Journal being out, and the presenter being able to speak to, and enhance, what's in the Journal. That may not be the case for this presentation, but some day, hopefully soon, it will be.
I have no experience as to what the big conferences are for the diseases we're working on. In cancer I know people target on ASCO, AACR, etc. but I don't know about this. Can someone indicate when the really big conferences are held and whether they believe the company will be making presentations at one or more of these conferences.
As I gather it, the first real news we can anticipate is either filing an MAA, or issuance of a Journal. The company has more control of the filing of the MAA, but they may be reliant on contractors for certain aspects of the submission. As for a peer reviewed Journal, they have little or no control, if modifications are requested it's likely the lead clinician would coordinate making any changes. Like almost everything in biotech's things take longer than investors think, and often longer than management thinks as well.
Gary
They are ready, the Sawston facility has been approved in the UK where they're applying for approval. I'm not saying the facility can meet the full demand, but I believe capacity is being increased and the EDEN approval may be possible by that time. The point is, they can sell the DCVax-L from day one, the demand may be many times what they can initially be delivered, but as long as the cancer is being properly preserved they'll have an opportunity to get caught up.
I believe that once approval occurs the company could make further announcements on how they intend to meet demand.
Gary
I could be mistaken, however I believe that either a reverse split or increasing authorized shares would require a shareholders vote. If I'm correct about that, personally I'd prefer more shares being authorized. My experience at NWBO seems to indicate the way their options and preferreds are structured they're not being counted toward the O/S. It's certainly a debt that must be addressed in the future, but shareholders will be only too happy to address it if our share price were in dollars, not pennies. One major contract could potentially do that.
Gary
My primary investment is NWBO, I recommend it to all as potentially having explosive growth potential as it's vaccine which is made from the tumor while trialed in GBM should be effective in all solid tumors. They have applied for UK approval. I bring it up because like here, they have options and preferreds that add to over the 1.7 billion shares authorized, but the holders all seem to be working with the company. I expect that once they have approval and a much higher share price they will get more shares authorized, but it wouldn't surprise me if once revenue justifies it if they acquire the options and preferreds.
My point is, the high share count isn't a killer when the earning potential can be in double digit billions, or more. Firms like Apple and Tesla have billions of shares outstanding, it hasn't hurt them at all. If our technology ultimately ends up in the batteries of many of the different vehicle producers, I believe that we too have earning potential in the billions, if not double digit or better billions. One billion in earnings should support a market cap of $10 to $30 billion, IE a P/E of 10 to 30. If our O/S went to 2 billion, that's a $5 to $15 share price on a billion in earnings. Personally I would rather see that than a reverse split that could practically halve the market cap at the time if it goes the way of most reverse splits.
The really big news ought to deal with companies using our battery technology, as well as sales from the new acquisition, it shouldn't be about the fear of a reverse split. If the current holder of the company being acquired take preferred shares it won't even show as shares outstanding. As the company grows, if the holders of preferred shares need cash, they can certainly convert gradually and sell as they deem necessary to do so.
I'm new to the company, but I've seen how NWBO has worked for a few years and while they've yet to have serious money in the bank, they continue to operate on routinely selling some shares, and taking some loans. My point is, you can continue to operate this way until you have the success that an approval of their vaccine will bring. For us, a major contract to use our battery technology would provide the same sort of success.
Many here have much knowledge of the batteries, which I'm trusting, if our technology proves to be the basis for both current type batteries and future solid state batteries, I see no way that this company doesn't achieve at least a double digit billion dollar market cap, or be purchased for double digit billions or more.
Gary
DD, they are saying that they could go either way. Historically they have kept small while contracting out most of the work. I see no reason to believe that they will operate differently with approvals.
Gary
Companies generally either announce when they file, or when they get notification of acceptance, some companies PR both.
Gary
I don't know nearly as much as many here, only invested a little over a week, but I still believe in the company and think the stock dramatically overreacted to what in time should be good news. I doubled my position at $.017.
Gary