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Thanks Flipper, that had to be an unusual buyout, but I suppose if shareholders accept the fact that a company is greatly undervalued anything is possible. Even at 5X we'd need to reach at least a $4 share price to get they minimum I've gathered LP would take. That's a price we could easily reach if news is generally good this year, I'd be very surprised if it could get a $20 a share offer.
If we achieved the right media attention for what our vaccine will do when combined with Poly-ICLC and/or Keytruda, I'd not be surprised it we got a huge spike up to $20 or more, I don't see it being sustained there, however, if either a partnership or buyout was established during such a spike, almost any price could be sustained as it would be validated by the offer.
I've got to believe that at some point the company will go for major media attention. In the time I've been a shareholder I cannot remember a single time when LP has spoken at a brokerage or Institutional conference, or even sponsored a presentation with an organization like BIO. Once news starts coming out on DCVax-L with other therapeutics extending 5 year survival to 50% or greater I believe that LP will very routinely be invited to discuss the company, and of course our share price will be much higher. I don't know for certain when this will happen, but I believe it could come with the UK approval, so it may not be that many months away.
Gary
The approval and sales of DCVax-L will certainly raise the price, hopefully sufficiently for either a Nasdaq or NYSE application. I've heard that there is a course of action they could take to get on the Nasdaq below $4 because they were previously listed, but I've also heard that LP really wants the NYSE. We definitely have to get on a major exchange before we can get the sort of market cap, or buyout, we want.
I believe that a compromise, if they wish to take it, is the AMEX. I understand that you can file for that at a price above $1 which should be easy to reach after the initial approval.
Frankly the exchanges, who use stock price, and not market cap, to determine who can list, are largely forcing many companies to do reverse splits which almost always diminish market cap, at least initially. I respect the company for reaching a major exchange the right way, buy building the stock price. I really believe the exchanges ought to use market cap, not share price, to determine listing eligibility. NWBO has a far greater market cap than many stocks on the major exchanges. I understand that year's ago NWBO did reverse splits, they've learned from that and don't want to do it again.
Success with a high share count is certainly not a problem, look at ABBV which just bought out IMGN and another company for billions, it currently has over 1.7 billion shares outstanding. If NWBO remained independent and had tumor agnostic labels for both DCVax's I don't know that they couldn't have a market cap as large as ABBV's, nearly $300 billion, in fact I still believe a trillion market cap possible if our vaccines are being used for practically every patient with a solid cancer.
Gary
I certainly hope you're right. I have no idea about competition for our drone, but watching the video certainly is impressing me about it's capabilities. I believe that if they switched to toroidal props they could either handle greater payloads or increase flight duration, and the unit would be quieter in flight. I believe that these props can replace existing props with almost no other change to the drone, just better performance.
Gary
If there's a buyout, it will be based on the market cap at the time. Double the current market cap is roughly the best most companies can do. I don't believe that their is any figure that can be named that isn't achievable in time if the DCVAX-L and Direct prove effective in most solid cancers. Clearly it will take a lot of time, and if the company accepts an offer before that happens, it will be for less.
When we talk about $20 to $40 billion it is very possible to achieve on the strength of DCVAX-L in brain cancer alone, if it is being used in much of the world. I see that possible in a couple years. Perhaps less if major media highlights what the company is doing.
We've all seen other products claiming advancements in GBM, they are true, but nothing close to what DCVAX-L does when combined with other products. It won't be that long before much of the world knows that this is the case. How much you want for NWBO may purely be a case of how long you're willing to wait.
Gary
Illegals can't vote. Bush did far worse in invading Iraq, then leaving all the weapons behind as troops advanced. Saddam was a terrible man, but not the cause of 9-11. The world has many like him, Putin should be on top of the list but Trump likes most of them.
Remember it was Trump who said that we would leave, Biden executed it, and frankly I think the military developed the plan and did a horrible job, but it was on Biden's watch so he's to blame. It wouldn't surprise me if the military just wanted to get rid of a lot of old equipment so it would be replaced with new.
There are no easy answers, Israel can kill Hamas, but nothing will kill hatred. Making a permanent peace can only happen when people stop hating and learn they can benefit one another in peace.
We need a traditional Republican party, not one that disrespect the Constitution.
Remember it was Republicans that told Nixon that he had to go, that is the kind of Republicans that are needed today.
Gary
As someone who worked for the DOD, I can't agree. Our weapon systems are the best in the world, but we try to not use them excessively and potentially start WW3.
Our Congress is our weakness IMHO, it fails to reach compromises because it's loyalty to party exceeds its loyalty to the country that its elected to work for. We really need to do things like funding for Israel and the Ukraine without delays and deal with our borders and aliens as completely separate issues. Now after many years of talking they appear closer to a bill than in decades, but without seeing it Trump says no deal. What happens to Israel and Ukraine funds, who knows, before it couldn't be done without border legislation. We need Congress to work for the Country and place the Party in second place.
Gary
When we speak about military drones, I believe that some differentiation should be made between the sort of drone we've developed, and they type with wings which must either take off like an aircraft, or be shot up and has wings that open, etc. and either must land on some type runway, or be captured by flying into a net. I believe the major defense contractors like Boeing and Lockheed are making more of the winged versions which are generally larger and carry weapon systems. I'm certainly no expert, but really don't know if the major defense contractors are competing for the sort of drones we're making. I certainly don't know, but suspect that if our drone was being deployed to guard a base, like the one which had many injured and 3 killed, it would have picked up the incoming enemy drone and differentiated it from an American drone returning to the base.
I need to learn more about things like the charging time for our drone, but if it can charge in under one hour, two such drones sharing a single charging station could autonomously survey an area like the attacked base 24/7. I don't know that one such drone in the air could spot an incoming weapon, but my point is a given area could be constantly surveyed and any anomalies reported, and no human intervention would be needed unless action needed to be taken based on an anomaly that was noted while airborne and scanning.
Gary
Smitty, I believe that CRL will be doing most of the work, NWBO will coordinate new trials and develop new products, but not be involved with getting the vaccine to the patient.
Gary
Aperture,
You certainly could be right, but I believe that a BP that did take a substantial position in NWBO might actually make more from the stock appreciation than if they acquired it. My reasoning is something like this:
Let's say they purchased 20% of the stock for $2 billion which essentially raises the market cap of the company to $10 billion instantly. Now let's say the company does what I believe it could, turning the DCVax's into a part of the SOC in many solid cancers. I think earnings over time would reach $50 to $100 billion and continue to grow with the vaccine being used in almost every solid cancer patient.
If a P/E of just 10 were applied, the market cap would be $1 trillion if the earnings were $100 billion, or half a trillion if $50 billion. The 20% of the stock they own would be worth $100 billion to $200 billion, but that's at a P/E of just 10, with revenue increasing dramatically each year the odds are greater the P/E will be more like 30 making their stock worth $300 to $600 billion. By owning the stock they'd be seeing an excellent asset with virtually nothing but their initial investment.
I really can't say owning the stock will be better than acquiring the company, but a tiny biotech like NWBO can grow far faster than a BP that picks up additional blockbuster drugs, even ones as big as the DCVax's could be. I don't believe that LP would sell the entire company for $10 billion, or even $20 billion, perhaps $30 billion, but I do believe that she might take a couple billion for 20% in order to move the company into the major growth that it could bring. Such a partnership could come much sooner than a buyout, but it also will bring on the growth we'd all want to see far faster than if the company has to continuously scratch for funding.
Gary
Thanks Marzan,
I'm essentially in the same position as many of your minions. I really haven't decided, but if the buyout of IMGN is confirmed tomorrow, I may be looking at getting some more shares, even though I've said I have enough many times.
I don't believe it will be that long before many NWBO Millionaires are created. Some here probably have over a million at todays prices, for them, double digit millions won't be far away.
It's amazing how many people seem to believe that millionaires are only made in blue chip stocks. I think I mentioned EPAZ last week when I got some, I liked the drone they're building that's being tried by the military. At barely over a tenth of a cent then, it's now closer to two-tenths, and news is still anticipated. Some investors I chatted with believe it will not be discussed in pennies much longer. I don't know that dollars will be discussed for some time, but a dime is a huge gain when starting at just over a tenth of a cent. I believe it's far easier having a penny stock reach a dime than it is for a Tesla to go from $200 to $2000, the very same percentage gain. For NWBO, I believe that $6 or more can be experienced this year, that's a ten banger from where we are. Our potential to go much higher is great, but who wouldn't settle for ten times the current price in a year.
Gary
Thanks Sharpie,
I believe that the information in the full link on how insurance pays for off label use through getting the product listed in a compendium of products used for a specific disease. I believe our vaccine can be included well before trials can possibly be completed, assuming trials will be done. With this approach, once approved a product can easily be included for off label use without formal trials.
I do not believe that once Doctors learn about the DCVax's, and they realize their patients will gain benefits with essentially no negative side effect, they'll eagerly use it without a major advertising effort. I believe in commercials products can only discuss label treatments approved for it, if I'm wrong about that, and compendium uses may be included, please correct me.
Gary
Smitty, I can see your valuation on GBM or brain cancers alone, but I do believe the tumor agnostic label will be applied if the company isn't bought out too soon. If that designation is achieved, I think the decimal point could move one or two places to the right.
I'd much prefer partnering with a BP than having NWBO bought out by them. A few billion dollars for a small percentage of the company would be far more preferrable to me than a buyout. A BP with say 20% or more of the stock would gain one or more seats on the board and have a very big influence on the direction the company takes. The money such a partnership would provide should easily cover the new trials, new product development, and other needs as the company's sales revenue is growing. Such a partnership would essentially raise the share price to the price the BP was paying for their percentage of the company.
Gary
It's funny, I believe you're right about GBM being the toughest of cancers, but I believe that if they had gone after pancreatic cancer they'd have had little problem getting a tumor agnostic label, but I'm unsure it would include brain cancer. The Blood Brain Barrier has been considered the reason so many other therapeutics don't work, I wonder if the fact that our vaccine works provides the reason that without further testing they don't want to say Tumor Agnostic.
As I remember the data we've seen from DCVax-Direct one of the longest living survivors was a pancreatic cancer patients, there were others in the data, some living, some deceased. If this is a precursor to what happens when DCVax-L is used in a variety of cancers in a bucket trial we should be in great shape.
Gary
It's really not up to the company as to when the Air Force, or any other part of the DOD actually finalizes a contract. Even high ranking officers in the service often can't move Govt. buyers, unless there is a national emergency. An officer may have told the company, you should have it next week, but that officer doesn't make it happen, some Govt. buyer does.
I know I've told the story before, but I had a project that I was in charge of that I insisted could only be done with computers, I was told I'd have them in 8 weeks. We provided all the information to the buyer, the price was under $600 a unit. In spite of routinely pressuring the supply officer for support, it took about 20 weeks to get those computers. The buyer was proud as she could be, she saved $50 a unit below the price we'd suggested they were available for saving the Govt. $400. It probably only cost the Govt. an extra $10K in overtime to get the project back on track, but Govt. buyers don't consider such costs.
It's been decades since I dealt with the Govt. buyers and the supply system, but I doubt if it's changed that much in all these years, though now I'm sure they too have many more computers to assist them.
Gary
Marzan, I certainly don't know your people, but I suspect that if they did as others have said got in at $1.20, they've also taken advantage of the much lower prices we've seen since then, and probably have their average share price down to well under $1. I believe they're satisfied with their investment now and waiting for the profits they know will be coming in the not that distant future.
I fairly recently spoke with the spinal surgeon who invested and knows Dr. Liau, he's as confident today as after he looked into the company and made his investment at prices above those we're at today. He's now primarily practicing in New Jersey, but may participate if I need further spinal surgery, which I'm considering.
Gary
JT, I believe you're right about some things, wrong about others. I would agree that it's unlikely that LP will do an equity partnership with a BP based on prices the stock achieves this year. What I don't agree on is that it won't be a good year. I believe that UK approval and other developments can easily put the stock price in a range from say $3 to $7 and possibly far more than that if EDEN has been adopted for commercial production and other regulators are in the approval process.
In that I believe that LP wants somewhere in the $20 range or more from a BP for them to take an equity position, I don't believe that she'd be able to achieve that until NWBO is trading in double digits. If all goes very well, it might be possible this year, but I'm more inclined to believe that the $3 to $7 range I mention above is most likely. That isn't bad news, in fact I'm speaking of a 5 to over a 10 banger from todays share prices. Who would consider a 5 to 10 banger a bad year.
Could it be better than that, sure, could a BP partnership in new trials happen, certainly, but if there is an agreement for the BP to purchase shares, I believe it would have to be based on the share prices after certain milestones are achieved. New trials don't just get started as soon as we have a commitment to do them, they take many months after IND's have been filed. I do believe some are still possible late this year, but I believe it will depend on other things occurring first, among them the UK approval, and the acceptance of the EDEN unit at least for conducting new trials. Hopefully we'll get a better understanding of where these things stand in the Annual Report and/or Annual Meeting.
Like many here I'm considering purchasing more stock, especially if it continues to weaken. I've previously sworn I wouldn't do it, but I can't help believe that it's a tremendous bargain and worth reconsidering. Tomorrow I'll know if IMGN's buyout vote went the company's way and that too may influence my decision.
No doubt a few years ago most of us thought that by this time DCVax-L would be selling all over the world, clearly that's taking far longer than we'd thought. I cannot say the company led us to that conclusion, they never said it would be that easy, we simply saw the trial complete, were happy with the data, and believe it would simply be a slam dunk to gain approval in a year or so. I for one certainly should have known better, I've seen it take longer with many products, but this seemed more compelling than most of the others. I do believe it will have far more impact once approved, but it's taking as long as any of the others.
I still believe UK approval is possible first quarter and very likely by the end of the second, but that doesn't mean it can't go beyond that. In the past I've seen drugs that became tremendous blockbusters held up for years because a regulator asked for something that was never requested when the Phase 3 trial protocol was developed with the regulators assistance. Drug developers almost never complain about the actions of the regulators publicly, but I'd love to be a fly on the wall when they receive such news from the regulator, and hear what they say privately. I do believe the regulators are improving, instead of delaying approval they're conditionally approving more and requiring confirming trials if they're still having doubts on seeing the initial application for approval. It won't be that long before we know that the UK is approving based on the submission, or that it's taking longer because they want something more, even if the company doesn't come out and tell us so. We're in a 5 month protocol, if we don't hear in 5 months, it's likely the company is supplying something more for them to evaluate. JMHO.
Gary
I keep trying to tell everyone that massive vaccine production plants are nothing like the EDEN which only produces one batch for one patient at a time. Could Merck or anyone else produce something that essentially stacked many ADAMs together, sure, but each would be making one batch independent of the others.
If something is going to happen between NWBO and another company intended for DCVAX-L production, they would need to have a great deal of clean room space and design the room for the accommodation of many EDEN units.
Until we know more about the optimized EDEN units I really don't know how you design such a facility. For instance, how critical is it in terms of the temperature and humidity flowing around the EDEN. The company probably knows all that is required by now, and this may have been provided to those who may be making the commercial vaccine in the future, but I don't believe any of us know what is required.
I still believe that it is far more likely that Advent and CRL will be doing this task than a BP. Even if a BP purchased the company I am not sure that they wouldn't leave production and distribution untouched. A personalized product is very different from what BPs normally handle.
Of course, some believe that NWBO will build their own production facility and that too is possible and perhaps has a BP partner.
Gary
Chiugray,
We need to remember our vaccine doesn't do it alone. In many cases our vaccine and new or existing products from the BP's will prove most effective against certain cancers. Perhaps certain products will no longer be needed, but others will be, or new ones developed, to really make out vaccine more effective. You can bet if Dr. Liau is achieving 60% 5 year survival in GBM with what she has now, she'll still be working to chip away at the 40% who aren't living 5 years.
I'd love to see her reach 90% or more and believe that when she does, DCVax-L, or an improved version of it, is still playing a part.
Gary
I agree, in the 1950's we were referring to Japanese cars as Japanese Junk, but it just kept getting better and better. Many years ago I had the pleasure of taking a multi-day course with Dr. Deming, an American credited with teaching the Japanese after the war with why we were so good, his message was continuous improvement. You simply don't stop improving, and in Japanese companies, even the janitor can stop the assembly line if something wrong is observed. It's corrected and the line is restarted.
If we were actually constantly improving, our cars would have remained higher quality than those from Japan, but unfortunately what Dr. Deming was teaching in Japan wasn't being practiced here at all. Even today most management is more interested in maximizing their bonuses for this year than doing the things that will continue improving their products and build greater sales in the long term. If it were up to me, bonuses would be based on how well projections from years ago have been met, and making long term projections and establishing long term goals.
In Japan, workers were looked on as a company's assets, good management's job was to keep the assets working well on new and improved products they'd develop. The last thing you wanted to do is lay off your assets. Here management often gets big bonuses by reducing workers instead of developing products that keep them working profitably for the company. Hedge fund managers get huge bonuses for bringing down companies.
Gary
I believe the more that we erect tariffs, the more others will do the same. In the end we'll all be paying more from products from other countries, and they'd be paying more for all that comes from here. I'm not saying that some actions shouldn't be taken if a country is playing games with the system to dramatically favor their own, but subsidies with a legitimate basis are used all over the world.
Of course I also don't agree with higher interest rates charged by the FED reducing inflation. Money spent on interest is practically like putting a match to it. Slowing an overheated economy with briefly higher rates might be okay for a short period, but dramatically raising rates over a long term has people spending far more on interest, which itself helps to create inflation. Thus far our economy has been amazingly strong in not going into recession after all the FED rises. If the economies of the world are to do well, interest rates need to come down, possibly not as low as they were when I got a mortgage for under 3%, but the 4 to 5% range keeps real estate growing well and makes people happier with their lives.
I can't say how much the Chinese Govt. subsidized the development of their battery manufacturing plants, but I believe that our govt. should help incentivize the development of new technology battery plants. Incentives may be money the govt. spends up front, but the sale of American cars with American made batteries in them will eventually pay all that money back with interest. After World War 2 we helped in rebuilding German and Japan, and in doing so greatly modernized their industries, while not doing the same for our own. Now we're at the point where the solid state sodium battery is in it's infancy. What better time for the Govt. to help American industries become world leaders in this technology.
Gary
He's entitled to his opinion, and they are building some fine cars in China, but I believe that with the right investments, and perhaps some Federal incentives, probably no different from what companies get in China, we can compete.
I remember the 1970's when mostly Japanese cars were considered to be better than American cars in the same price class. Sadly that was proven to be wrong, but it was proved by Japanese companies building plants here and producing cars that equaled the quality of the cars from Japan right here at competitive prices. Today all sorts of gas cars are made here, as well as some fine electrics like the Genesis GV70. Unfortunately the GV70, and some other fine cars, plug in from the front grill and in my garage that would put the plug under a storage shelf making it very awkward, especially at my age. I've had to eliminate them from my consideration.
I've got to believe that some of the equipment used in manufacturing batteries can probably be adapted to making solid state sodium batteries, but if we're starting from scratch here, I don't know that we can't do it better. I suspect that by the 2030's people will be amazed at the products being made in America that currently are only available from elsewhere, often from China. I'd guess that computers then will be far more powerful, but use far less power, and if they're battery powered, the batteries will be both smaller and far more powerful, so charging once weekly will probably be all that's needed by most.
Gary
I know very little about the sophistication of our drone, compared to the one that was confused for an enemy drone that killed 3 and injured many American's. I wonder if it had been our drone if it would have spotted the enemy drone and made certain the soldiers knew what they were looking at. There are so many different types of drones and in our case it can be equipped with many different sorts of censors, I just have no idea of exactly what the soldiers were flying, or what they were looking at.
Hopefully the order for our drone will be executed shortly, but if we're successful, this is just the infancy of what they'll be getting from the DOD. What I'd hope for is for this drone to be the first of a series of drones the company develops for the DOD. I believe that once they have a contract with them it opens the door to the development of other products that they can compete for.
I live near LAX in an area where I don't believe any drone is permitted to fly in. I do believe it won't be that long before drones will be used by the likes of Amazon for deliveries. The question may be, if a drone like ours can be shown to operate very near the ground safely, and do so automatically, could it possibly deliver in areas where other drones are prohibited. To my knowledge, on at least two occasions drones flew in the flight path of airliners, clearly illegally, I don't know if the owners were ever caught, but clearly they could be a major problem if they struck the wrong part of a plane, Much the same has been done by people in flight suits near the airport. I don't know that drones like ours couldn't actually be positioned to find and track any such intrusions around airports and work to arrest those who do such things.
Gary
A friend who used to supply certain materials to Space-X told me that Musk and his key people would brain-storm in a smoke filled room, and it wasn't tobacco smoke. I do believe that creativity is improved in that way.
Musk's personal worth has got to be down dramatically with all he's done recently, but I don't believe he sweats it personally, and frankly I doubt if he cares what his ego does to those who invest in his companies.
I will say, the new Tesla 3 has some nice improvements, but it's still not for me. Friends of mine have one ordered and test drove it, they have a current 3 and assured me the ride is greatly improved. Right now I'm interested in the 2025 Mustang Mach E due out mid 2024, hopefully the improvements I've heard about will be correct, and by that time NWBO will have reached a share price that I can buy it with pocket change. I will say the dealers were making great deals with the 2023's and a friend checked on it and purchased it on my recommendation.
Toyota is talking about fast charging cars that have ranges around 800 miles, but won't be available till late this decade. I'm sure that Musk and others will find a way to complete with them. If I'm not mistaken, the batteries will not be primarily lithium based, and I expect many of the high flying lithium stocks to tank. Solid state sodium batteries seem to be the key to the future, and there is no shortage of sodium. I still believe that carbon nanotubes will have an amazing future, but it could be a decade or two away. While today China is providing many of the batteries, hopefully new plants will be built here and elsewhere in the world so we're not reliant on China, or anyone else for that matter. Musk has done a good job getting this started, but the competition's getting greater and I believe his share of the market will be diminishing, though his numbers will continue to rise.
Gary
Many here are speculating on Merck, Amgen, or others building production facilities that could be used for DCVax-L production. I'm not nearly as concerned about who will be doing it as how it will be done.
I certainly believe that the EDEN is the key to massive production, but it's not mass production. Every EDEN can only make one batch of vaccine at a time. I believe that the EDEN will be computer controlled, but I don't know if every one will be tied to a single main frame, or if each site will have a computer, or if only XX many EDEN's can be controlled by a computer. I would expect them all to be backed up in some way, and I think they'd all be networked to NWBO who could monitor production in every EDEN unit regardless of who's operating it. I would also believe that every disposable cassette manufactured by St. Gobain's Glass would have it's own identifier that ties to the computer and ties to the patient who's vaccine is being made.
I believe that production will probably be by Advent and CRL, at least initially, but the details won't come till we have approvals for both the EDEN, and from the country where the vaccine is to be used, with the exception of the UK where they already have approval to commercially manufacture manually at Advent for UK and perhaps other applications.
If in the next few years we gain worldwide approval to use DCVax-L as a tumor agnostic therapeutic, I doubt if anyone currently has nearly the cleanroom space and other things required to meet the demand that will be developing. Perhaps we'll see the development of an improved version of the EDEN, perhaps a single device that holds many disposable cassettes, each one individually making a single batch of the vaccine. The key is still the fact that every batch must be individually made. BP's are into making products for many patients simultaneously, this is a very different animal than anything else they make and sell.
Gary
I must admit, I admire Elon Musk's ability to innovate to improve on many things. He didn't invent the electric car, solar cells, or rockets, but he's improved dramatically on all of them. I don't however like some of his views, though frankly at times he speaks without thinking, than thinks about what he said, and essentially reverses himself. I can't say I like what he's done with X, but I must admit, there is some great information over there. I really don't intend to establish an identity there, but I can't ignore it either.
I hope that some of the longs remain here, but my advice would be, if a short is saying something that's been heard repeatedly, just ignore it. I believe that we keep them involved by answering their allegations, even though they've been answered many times previously, though the allegation was made by someone with a different identity, but who may have been the very same person.
Perhaps the day will come when every post will be screened by AI and if the authors position had been stated, and discussed previously, the author will get a rejection with a link to all the prior information on that subject. IE we'll never see posts in which nothing new is being suggested or questioned. I believe we're a long way from being there, but AI is certainly getting a great deal of attention.
Gart
CO, I certainly don't know if UK approval will simultaneously end their compassionate use program, or if people that either can't avail themselves of the UK healthcare system, or wish to use DCVax-L off label, will still be able to get it in this program. At some point, perhaps after DCVax-L has been approved by all regulators looking at it, I'd think the program would end. Perhaps once that happens the results of all the patients in the program will be released. I really have no knowledge of how they'll handle it. For all I know, the data to a specific date may have already been in the submission made to the UK. Point is, we really don't know, I would hope that the company has had access to the information, but even that isn't known to my knowledge.
We learn about anecdotal evidence when patients go public about their treatment, several of the people who are running go fund me campaigns to get DCVax-L have been open about how it's working for them, many have brain cancers, but others do have other solid cancers. There are probably many wealthier patients who've very privately received DCVax-L, I don't think we'll ever see anything with their name on it, but at some point we may see some sort of summary that indicates how people with various forms of cancer did, including how many are still alive after XX months, or years. Of course we'll never know just how advanced their cancers were on receiving the vaccine. I would suspect that many patients were very advanced and had become refractory to SOC treatments before trying DCVax-L, but I have no knowledge that this is the case.
Many years ago I met a man who'd lived with pancreatic cancer for over 5 years without the Whipple procedure. He would search for Oncologists willing to try something new to keep him alive, when the Oncologist had no more new ideas, he'd find another oncologist. Somehow, all the various things they were trying on him kept him alive, the cancer eventually became refractory to the new treatment, but another new treatment worked, for at least awhile. Clearly, none of the treatment he was being given was approved for pancreatic cancer, it was purely off label drugs, and all sorts of diets, etc. He had the funds to do this, insurance would never cover treatment like this.
Gary
Smitty, what you're saying simply isn't true. In my treatment for leukemia, many of the therapies that I had were never tried on my specific form of the disease, but anecdotal evidence has been all that's been necessary to have them used without questions from insurance, or anyone else.
In many cases patients have sued to get products that weren't approved for their disease, I don't believe there is a lot of resistance to off label use of many products if substantial anecdotal evidence exists of its efficacy. If a product has been generally accepted as effective and word has essentially spread to most Doctors in the field, why should a company run a clinical trial.
The benefit of the clinical trial is the expanded label, the ability to advertise that capability, if advertising is deemed to be needed to expand the use of the product. If the product has been accepted without such a trial, companies don't go to the expense of running them.
Do I expect NWBO, perhaps with one or more partners, to run basket trials in multiple solid cancers, yes. But will they be in every form of cancer they believe that DCVax-L could benefit, no, nowhere close to it. I believe positive results in a few major solid cancers will prove sufficient to gain a tumor agnostic label. I believe that scientifically DCVax-L and other therapeutics will prove things like a huge increase in the number of T-cells in the tumor, the logic will say that this is a positive that should make it effective in solid cancer types that are not in the trial. One thing I believe that you can bet on is that even before the basket trials are run, there will be Drs. and patients who'll be using DCVax-L off label based on the anecdotal evidence that already exists.
Gary
Smitty,
As I understand the compassionate use program in the UK, people who had the funds to have DCVax-L made with their tumors did so with many types of cancer, not just GBM or other brain cancers. I believe that substantial anecdotal evidence does exist that benefits have been seen from the DCVax-L treatment. We need to remember that many patients with a variety of cancers understand that their lives are very definitely at risk and are willing to try something new that may extend their lives, whether it could be curative, or not. Whether you're doing a clinical trial or compassionate use on patients with terminal diseases, deaths have to be considered normal. When someone thought to have months to live suddenly dies they certainly look at the possible cause.
Herceptin, which was conjugated to create Kadcyla, is one of the most successful oncology products. I'm uncertain if even today a test has been developed for an allergy to Herceptin, but I know that a very tiny percentage of patients have died shortly after receiving it, and have been deemed to be highly allergic to it. My point is, you don't remove a product that's highly effective for the greater majority because of a detrimental effect with a tiny minority, but you do try to deal with it once you know of its existence. In our case, since our vaccine is made from the patients own cells, it's doubtful that any such allergy exists.
I've just attended a funeral for a friend who looked healthy, knew of no health problem, but suddenly died of a heart attack. Such people also get terminal diseases, they may be in a clinical trial, and they too may die suddenly from something completely unrelated to the trial. Such events may result in temporary halts in a trial, but in the end the trial normally resumes. Year's ago I was told that may companies doing trials in the US hesitate at allowing compassionate use as if a patient receives it, and dies prematurely, it can halt a trial while they investigate the cause of death, essentially it's added risk with no reward.
Gary
In the UK system the commercial manufacturing facility was inspected and approved before the MAA was filed, it's the Sawston facility using manual production methods. I know in the US but am not certain about the others that the approval of the production facility is part of the BLA so it need not be inspected prior to submission. On more than one occasion in the past I know drug approval was put off because the production facility was deemed to be inadequate resulting in a substantial delay. It's my understanding that the FDA gets 6 months after problems are addressed, I think a new PDUFA date is established. Perhaps they won't take the entire 6 months, but it's certainly best to be ready for inspection well before he PDUFA date so minor problems can be corrected and reinspected before the date.
Gary
A big part of the problem is people giving credible answers to the same issues that have been brought up by other named posters for years. I believe some of these posts were written by the same people using different names, others by new people, but every one of them know the answer before they ask the question, they just like to maintain a degree of frustration here, sort of like a dog chasing its tail.
I try to ignore all I can from these people.
Gary
Hope you are right, but it's a brand new game. Luck sometimes is more important than skill.
Gary
Let's talk profits. Sukus was contending that profits begin essentially with approval, and there is a case for that. It's also very possible that with approval the company needs far more money to do what needs to be done. The question is how is the company going to play the game.
In the UK they have Sawston prepared to deliver DCVax-L utilizing Advent, even there some change in the relationship with Advent is probably required as the terms will change between providing the vaccine for compassionate use, and providing commercial product. I believe that NWBO will receive far more from Advent once they're delivering commercial product. I'm uncertain if that has been completely defined, or if more is to be revealed, this is especially true once the EDEN is approved, and NWBO makes the determination of how it is to be used.
I believe that the greatest long term profit would involve NWBO taking over all commercial production with the EDEN once it's approved, but this would involve them taking on tremendous costs of not only building all the EDEN's and facilities to house them, cryogenics, etc. The advantage is they would be earning every penny that came in for DCVax-L, but they'd probably have to raise hundreds of millions, or more to do so. I don't believe this is the course NWBO will choose to take, but long term it could bring the biggest profit.
There are all sorts of possibilities of using the EDEN once it's been approved. If initial profitability is the primary consideration, establish CDMO contracts in which companies like Advent, and presumably CRL pay NWBO for the right to be their commercial producer, and they pay to lease each EDEN unit they operate. With this option, with the CDMO's paying for the rights to make the DCVax-L for the company, they'll certainly keep more of the money charged for each batch. The full opposite of this would be NWBO paying for companies to be their CDMO's and supplying them at no cost the EDEN units to do the commercial production. This of course would be more expensive, but NWBO would be able to keep more of the money collected from each batch created.
It's my belief that a compromise between the extremes will be what happens, and everything could change dramatically if a BP partner comes into play that brings in substantial funds, perhaps for the rights to run new trials which combine both companies products in the trial.
My point is, it's up to the company, through the course of action they take, how quickly profit will be seen, and how rapidly it will build. If they have deep pockets and pay for services of the CDMO's they'll see more from each batch, but it will cost more up front. If they do the opposite, they can be profitable practically from day one on approval, but they'll make less for each batch.
I'm sure there are other possibilities, including a partner coming in and taking responsibility for all commercial activity, and bringing in lots of money, whether they have a equity position immediately, or established after certain milestones were hit. Anything is possible, the company is positioned to choose the direction they take as long as others are open to negotiation. One thing is reasonably certain, NWBO has substantial long term debt, unless they receive a massive payment it will be years before they'll have taxable gains because of all they prior and required costs to bring DCVax-L to market.
Gary
It seems to me that some of our most frequent bashers have dropped out, and new bashers who sound almost the same have replaced them, does anyone agree with my assessment.
Gary
Sorry I failed to mention something else in my earlier message. Your figures were conservative as you indicated a substantial percentage weren't having surgery. In some cases this may have been because the tumor was considered inoperable, but in others I believe it was based on the belief that something else was working. If DCVax-L proves to be significantly better than whatever the something else is, don't you think that many of the patients who could choose surgery, along with DCVax-L will do so.
The other question, which may be answered years from now with DCVax-Direct, is, in patients with tumors deemed to be inoperative, would it be possible to actually extract sufficient material from the tumor to make DCVax-L. I guess I'm suggesting something like a cross between needle biopsy and liposuction to remove sufficient mass to get the vaccine made. I'm asking, not saying it can be done, but I believe that today many things can be done with robotics that get into places that previously required major surgery with tiny specialized instruments.
I guess what I'm saying is with evidence that DCVax-L, perhaps with other therapeutics, is by far the most effective way of fighting these cancers, can we find a way to reach nearly all discovered with it.
Of course everything I'm saying about brain cancer should be equally true of other solid cancers after DCVax-L is proven to be more effective in treating it as well. I'd frankly hate to see NWBO bought out on the strength of brain cancer alone if a little more time will show it should be applied to many other solid cancers. I'm fine with a BP partner helping us get their sooner.
Some people think I'm kidding, but if NWBO remained independent, and if both DCVax's prove effective against most cancers, a trillion dollar market cap is not out of the question. It could easily take a decade or more, but I prefer allowing it to grow that way then some short term buyout, even at figures of $45 billion, or more. I would suspect that if we ever reached a trillion market cap we might have as many as 3 to 5 billion shares outstanding, such dilution wouldn't bother me if we had that sort of growth.
Gary
Sorry Biosect,
We're actually in agreement. Perhaps I wasn't clear, but upon approval in the UK what I suggested was prior to earnings actually being seen, valuation will certainly move up as revenue grows and I have little doubt that with growth continuing to be substantially higher with each succeeding quarter NWBO should justify a P/E of 30, perhaps even more based on the news. I believe it will take a few quarters worth of results for the investing public to see what should be happening here.
As for how fast things happen, much will depends on what the company says, and perhaps more importantly what it does. I have no idea if we'll be told that before year's end all regulators will be working on approval, or if the goal will be to go to one more before the end of the year. There is so much we don't know, but if the guidance says it's all coming to fruition very shortly, no telling how high we could go this year. On the other hand it may take longer, if it does we'll continue to climb, just not quite as fast.
I hope we'll have an Annual Meeting shortly and get such guidance, but I suspect the guidance may not be forthcoming until the company has achieved certain goals, and I don't know what they are, or when they expect to achieve them. LP is calling the shots and I can live with what she decides to do, even if I and many others may have done it differently.
Gary
Thanks Lykiri,
In my family we've really not made our birthday's a big deal, it's sort of a remembrance that we've made another trip around the sun. We'll get together with a few friends for dinner, but that's about it.
In the discussion of a buyout or partnership market cap, I think we all need to recognize that the price paid by the buyer or partner is often roughly double the price the stock has achieved immediately before the announcement. When speaking of $45 billion to purchase NWBO, I think a market cap of over $20 billion would be required, if we assume 1.5 billion shares outstanding, we're speaking about a share price of over $13, most likely over $14. With 1.5 billion shares outstanding, we'd all get $30 a share in such a buyout.
This may sound like a lot, but if prior to such a buyout it were clear that our vaccine works against most solid cancers, it would be a bargain. Note, I didn't say it was approved for anything beyond brain cancer, but if substantial evidence existed based on both anecdotal evidence and early phase trials in different cancers, I believe anyone offering to buy the company would do so in the belief that DCVax-L will become a major part of the SOC in many solid cancers.
Personally I'd prefer a BP like Merck co-sponsoring a new trial with NWBO with an agreement that at some date certain, after at least initial trial results were known, Merck could buy up to a specified percentage of the stock at a price based on the price after the data was revealed and at a specified percentage above that price. I suggest an arrangement like this because I believe it's something that could be put in place today, but should bring in substantially more money at the time Merck actually made the purchase. Merck would make an agreed upon price to NWBO on initiating the agreement which would be applied to share purchase when the option became available. Essentially this would be a partnership where at one or more specific milestone Merck had rights to purchase shares in NWBO and Merck paid $XXX millions up front to participate in. I doubt exactly what I describe above would occur, but the point is, Merck wouldn't be buying shares at a tremendous multiple of the current price, which it's shareholders shouldn't accept, but it would assure them of being able to purchase in the future at prices deemed to be fair to both companies.
As we stand today, I don't believe the company would consider selling a significant number of shares to a BP at less than double digit share prices, and no BP would ever pay such a premium. I frankly don't know if the company can prevent others taking a small position in the company, but believe it must be revealed as an Institutional buyer, and probably violates their policies because of the low price of the shares. This would change when we're trading for $5 or more and hopefully have moved on a major exchange.
Gary
Sukus,
In you're post, saying $45 billion after UK approval is working counter to saying real values are hidden and will be revealed long term. I believe you're right about things being revealed long term and that's when a price like $45 billion could apply. Immediately after UK approval, unless other things have been revealed before it, I don't see our market cap exceeding the $5 to $10 billion range, and may not go that high.
Much could happen before the UK approval, but we don't know that it will, we almost certainly will get an Annual Report, but it's LP's choice as to how open she wishes to be in that report. I really don't see her providing a lot of guidance to investors until she's also ready to hold an Annual Meeting which could come before, after, or simultaneously with the Annual Report, which should come in late February or early March. It's not completely impossible that LP will delay the Annual Meeting until the UK acts, she's ignored the deadline for doing it already and no one seems to be willing to force the issue.
I believe the guidance we get from the Annual Meeting will say a great deal about how quickly the hidden value in the company will be revealed. If we're told that new trials will be started shortly to establish the tumor agnostic label for DCVax-L, that could be big, it could get dramatically bigger if she indicated these trials are going to be co-sponsored with BP's who'll be using their products in combination with our vaccine. If it were also announced that all trials will utilize the EDEN for vaccine manufacture, that would be big, but even bigger if she said it's now also cleared for commercial production. Finally she could say when other regulators will be approached, or perhaps even announce that filings have already been made.
My point is, there is so much that may, or may not be revealed by the time we get UK approval, I don't think that we can estimate how high the market price, or a partnership or buyout offer, could be without knowing what will, or won't be revealed by the time we have the UK approval. If we get nothing more than UK approval, a $5 billion market cap would meet my expectations.
Gary
I agree with you completely. In the IMGN buyout, the company IMHO just didn't care about investors in the ABBV deal, I don't know why we couldn't have been given the option of taking ABBV shares, rather than cash only. I've been very outspoken in opposing the deal but IMGN is over 90% owned by Institutions, so it's purely up to them. I hope we never have to face a similar decision.
Gary
Sukus, you're right on the money, the only thing that could limit how far we go is a buyout that occurs before.
By the way, I hate to say it, but today we're so fearful of insulting one another that I don't believe that Blazing Saddles could be made today. Of course we can still enjoy it, because it was made back when we could laugh at one another and it wasn't offensive back then to joke with one another. I've clearly indicated being Jewish, there is nothing I like more than a good Jewish joke and I really don't care who's telling it. We all need to learn to laugh about ourselves, and others, it's far better than shooting, or fearing, one another.
I hate to admit it, but I do believe the chance is pretty great that a buyout will actually end NWBO. When it happens, we'll all be a lot wealthier, but some of us will regret it, as I have with IMGN. I'd very much prefer one or more partnerships with BP's, that would give us the opportunity to never discuss a share price we couldn't exceed. Under the right circumstances a BP partner, who takes say a 20% interest in NWBO, could make more money because of the tremendous stock appreciation than if they purchased the company and added the revenue to their own.
Gary
I agree that the potential is tremendous here. If you're interested in another one with explosive potential soon, look at NWBO. Their vaccine which is made from the tumor should be approved in brain cancers in the UK in the next 5 months, and elsewhere in the world shortly thereafter. After further trials their vaccine, DCVax-L is very likely to be approved for nearly every type of solid cancers. It won't happen overnight, and there is a good chance the company could be bought out before, but the upside potential either way is tremendous.
In the case of Epazz, the million from the Govt. will be big, but the massive potential comes if the DOD does a major buy into their drones. A contract for drones could easily go into the hundreds of millions or more.
Gary