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I agree, but in the release I think they state the cassette is loaded into the EDEN, no further human intervention is required until it is removed. One unit makes one batch at a time.
I also believe that payment will be somewhat like what is done in the UK for compassionate use. A large payment up front and additional payments as doses are administered.
Gary
I don't think that the cassette is removed from the EDEN during the entire process. It is routinely monitoring the contents and pumping them as necessary.
Gary
This is what I'm referring to from today's release:
Manufacturing using the "closed" Flaskworks system will also enable products for multiple patients (potentially up to a dozen or so) to be produced in a single (larger) manufacturing lab at the same time. Under the present "open" process (as with most cell therapy production processes to date), only 1 patient's product can be made at a time in each manufacturing lab, and the lab must go through special cleaning in between each product.
With the Flaskworks machine performing the manufacturing process steps, the manufacturing personnel will only need to operate and oversee the machine and transfer culture vessels onto and off of the machine for these manufacturing steps rather than performing the steps by hand. This will be crucial for scale up to producing DCVax-L for very large numbers of patients, because the personnel can be drawn from a much wider pool and not just the very limited number of technicians able to perform the process steps by hand in an essentially artisan process.
It's been established that manually it take slightly over a week to make a single batch of the vaccine. With all the special cleaning that must be done between batches, even 50 batches a year is probably optimistic. I'm uncertain where the 500 a year figure you're referring to is coming from, but achieving that would mean more than one batch is being in a day in each cleanroom, I don't believe that's possible.
Every EDEN unit contains the products from one, and only one patient at a time. Unless they've found a way to greatly accelerate what's a biological process, it will take about a week to make each batch. The beauty of the EDEN is that the disposable cassette is completely isolated from the unit itself, once removed a newly filled cassette can replace it immediately, no time is required to clean the EDEN prior to installing the next cassette. Perhaps some maintenance is required, but it should be far faster than cleaning and completely decontaminating a cleanroom.
Gary
Please explain how that would be possible. Each cleanroom is devoted to making only one vaccine at a time, it takes roughly a week to do so. It may be a suite of cleanrooms you're speaking off, I do believe that they have several, perhaps 10 cleanrooms in a suite.
I'll try reaching DI for clarification, but unless they somehow can isolate 10 areas that don't cross contaminate one another in one of their tiny cleanrooms, only one batch of vaccine can be made manually in a cleanroom at a time.
Gary
I believe that DCVax-L is DCVax-L regardless of what cancer it's being applied to. If NWBO remains independent I believe that all DCVax-L sales will ultimately come to them, but I believe they'll have one or more contract manufacturers that will handle all manufacturing, storage, and distribution of the vaccine as it's needed. The key is each vial of vaccine is identified to one, and only one patient. If a does is needed, sufficient vaccine is withdrawn, place in a small vial, and shipped cryogenically if required to where it will be administered. The larger vial identified to the patient, and their disease, would be returned to cryogenic storage.
I mentioned the vial being identified to the patient and their disease because if one patient were fighting more than once cancer, different vials of DCVax-L may be needed by the patient to fight different cancers, each would be made from the cancer being treated.
I don't believe that NWBO will sell the EDEN to anyone, I believe they'll be leased and the company will track every use, and every disposable cassette being provided for manufacture of the vaccine. I think a corporate computer will track every one of the vials of the vaccine that are generated. If a patient is deceased, the company will tell the organization maintaining the vial for the patient how it's to be disposed of.
I would suspect that any patient deemed to be cancer free, but with vaccine remaining in cryogenic stowage would maintain the vaccine in stowage as insurance should the cancer come out of remission.
Gary
BB, I'd like to be wrong, but I believe a clean room operating manually can only make one vial of vaccine in slightly over a week, so it's not 500 a year, it's 50. I believe the company is speaking about the small cleanrooms they built at Sawston, so each of those rather tiny rooms could hold 12 EDEN units so they'd make 600 a year.
I do believe much larger cleanrooms could be built and many more EDEN units could be installed in the larger rooms. I have no idea the size of the rooms that were built in the Memphis facility now owned by CRL, however I believe that CRL does have other labs which could also be equipped to make DCVax-L if the demand is there. The key will be having enough EDEN units to meet the growing demand and placing them in facilities already capable of handling them, as well as probably building new facilities for making the DCVax's alone.
It's clear to me that if DCVax's do get tumor agnostic labels and become part of the SOC for many solid cancers, tens or hundreds of thousands of the EDEN units will be needed over time. Essentially if you take the number of patients being diagnosed with a cancer in which DCVax-L is considered a part of the SOC in a year and divide by 50 you'll know how many EDEN's are needed. I believe that worldwide the number could easily go to a million or more, for each million that's 50,000 EDEN units. If we only had 12 units in each cleanroom, that's over 4000 cleanrooms. I'm not saying we'll need this for some time, but these are the kind of numbers that will be needed in the future with a tumor agnostic label, and that doesn't consider making DCVax-Direct.
I believe that if this all comes to pass and NWBO is still trading independently, it's market cap will be right in line with major BP's. I would expect that one or more BP would have equity partnerships in the company at that time.
Gary
I agree with you completely, but even if your estimate for the cost of the EDEN was off by a factor of ten, it would be paid for by the first batch of vaccine it made.
Gary
Barnstormer,
There are clearly two sides here, the company believes that they can gain approval without further trials using the EDEN, the doubters, mostly bashers believe the only way the EDEN can be approved is by running additional clinical trials with it to prove it gets comparable benefits. I'm certainly on the company's side here, but it will take time to know who's right.
I'm frankly uncertain if Sawston in a purely manual mode is sufficient to gain regulatory approval everywhere, but again the only way to be certain is trying it. I would suspect that discussions between the company and regulators would indicate the regulators feelings about doing it.
Practically every drug in trials is made with different equipment for the trial than what's used for commercial production. I don't know why the same sort of comparison that's done comparing the trial product with the commercial product won't work for our vaccine, but is fine for the products made by the BP's and others.
There is no doubt in my mind that if EDEN never existed, NWBO could be profitable on manually made vaccine as the demand would be high regardless, and while it would cost substantially more, it could still be done very profitably. The reason Provenge largely failed for DNDN was the lack of demand, at the price it really wasn't that superior to other therapeutics. Perhaps if they could have automated it, and lowered the price, the demand would have been greater. That's not the case with DCVax-L, especially when the likes of Poly-ICLC and/or Keytruda are added. This is a paradigm shift in the treatment of brain cancer, and probably others in time.
I certainly could be wrong, but I don't think the regulators will delay making the vaccine available to the public for years by demanding additional trials to prove the EDEN unit when they don't do the same with the commercial mass production equipment which is often very different from the equipment that made the trial product. If they say, make it manually in the interim time they have to know that sufficient capacity won't exist to meet full demand for the vaccine. Who will decide who does, or doesn't get the vaccine.
Gary
I agree, but I don't think that PLUG is a common household name either and while they have more financially than EPAZ, I think if you watch the video of their drone you'll agree that ours is far superior. A collaboration that combined the technology could be a big positive for both companies. Of course this is assuming that they can build a fuel cell that can be of benefit in our drone, I just think it might be worth a discussion with them.
I am watching PLUG and may take a position in that stock in the future as well.
Gary
Yesterday I saw a video on a drone developed by PLUG, which makes a wide variety of fuel cells and hydrogen generating devices, that operates on a fuel cell they developed. The unit had far less payload capacity to our drone. It got me thinking that if the two companies collaborated on a drone, our drone might be adapted to using a fuel cell, rather than a battery, which might have either greater capacity, or perhaps comparable capacity, but nearly instantaneous ability to refill. It was clear, their device can't do nearly what ours can, the only real question in my mind is could we have a fuel cell replace our battery with some benefits.
As I see it, this wouldn't be something we'd want in every case as our drone can currently land and recharge without human intervention, so numerous landing sites can be employed with no human intervention. With hydrogen fuel cells, each refueling would clearly require human intervention, but it could be done very quickly. Both possibilities offer different capabilities. I believe the Epazz unit has sufficient payload capacity that it could carry a fuel cell that might enhance it's capabilities.
Gary
Yesterday I saw a video on a drone developed by PLUG, which makes a wide variety of fuel cells and hydrogen generating devices, that operates on a fuel cell they developed. The unit had far less payload capacity to our drone. It got me thinking that if the two companies collaborated on a drone, our drone might be adapted to using a fuel cell, rather than a battery, which might have either greater capacity, or perhaps comparable capacity, but nearly instantaneous ability to refill. It was clear, their device can't do nearly what ours can, the only real question in my mind is could we have a fuel cell replace our battery with some benefits.
As I see it, this wouldn't be something we'd want in every case as our drone can currently land and recharge without human intervention, so numerous landing sites can be employed with no human intervention. With hydrogen fuel cells, each refueling would clearly require human intervention, but it could be done very quickly. Both possibilities offer different capabilities. I believe the Epazz unit has sufficient payload capacity that it could carry a fuel cell that might enhance it's capabilities.
Gary
In todays release it's clear contractors will be making the EDEN units, I don't remember anything being stated about the disposable cassette, which previously was to come from St. Gobain's Glass. I suspect that that continues to be true, but am not certain that it all may not come from a single contractor who might acquire if from St. Gobain's. I don't believe that they've identified the time required to produce one vial of the vaccine, or how many vials can be made in a year by one EDEN unit. We know manually about 50 vials a year is possible per cleanroom, but we don't know if the EDEN unit greatly improves on this production rater, or not.
Gary
My take on today's news is that it will very probably be near year's end, or later, before NWBO can commercially make DCVax-L with the EDEN unit. The question not answered is whether the company will pursue the approval of other regulators without it, and perhaps if they'd approach the FDA say 4 months before they believed it would be approved, thus the FDA inspectors would have 2 months before the PDUFA date to finalize an inspection of a production facility that includes it.
Frankly I don't see the company proceeding until they feel certain they won't be delayed by commercial production capability, but I don't know that with expansion of capabilities manually at Sawston that they can't propose initial use of that facility. It is up to the company on the approach they take, but I've got to believe that they communicate routinely with the regulators and get some guidance from them, but I don't know this to be a fact. If Sawston without EDEN cannot possibly meet the demands of multiple countries after UK approval, I don't see them proposing it for meeting multinational demand.
Today is the first time I can remember discussions of the dendritic cells clinging to the unit, rather than flowing through it, clearly they must have found a way of dealing with this, but didn't specify how.
Today's release certainly provides information that otherwise would have been pressed for at the Annual Meeting. I would suspect that the company may delay that meeting until they have an answer from the UK on the question of approval there. If I'm correct about that, it would put the meeting near mid year and I suspect they would effectively cover two years in a single meeting as mid year is actually the proper time to conduct them. This is purely speculation by me, for all I know they'll announce the AM very shortly.
Gary
I agree, but Poly-ICLC isn't owned by a BP, Keytruda is. Perhaps both companies are buyout targets in time, or maybe NWBO buys rights to Poly-ICLC, or the entire company. Stranger things have happened with stock manipulations.
I really have no idea where this all will go in time, if Poly-ICLC has the same synergies in other solid cancers than it has in GBM, that tiny company that's currently privately owned could become massive, but more likely will be bought out.
Gary
They've said the King didn't have prostate cancer, I really don't think they'd lie about that, but say he has cancer. Anyone, including a King, should be able to limit how much information is given, but that's a double edged sword as it also limits the advice he may get from experts on whatever the type of cancer he has. I'm sure his Drs. know some top flight experts who they can consult, but they don't know all of them.
If it's a cancer that's normally easily dealt with, fine, but if it's among the deadliest of cancers, I'd be open about what I was fighting if I wanted the best possible advice.
Gary
I could see a BP operating something like NWBO as a wholly owned subsidiary, but I really don't believe they want to mix mass produced products with personalized products. They might be willing to somewhat personalize a product, so say 10 variations exist of something that treats a million patients, so on average they make 100,000 doses of each, but they really don't want to have a million patients who's products are different from each other and they must make, store, and deliver them as needed. Best to keep technology, like that of NWBO's, in a completely different organization than one where products are made by the millions.
Don't get me wrong, the profits from personalized products can be tremendous, I just don't believe that you want to make them in the same facility that's producing other products by the millions. If the BP's cannot equal the efficacy of DCVax-L with mass produced products they certainly may want to own it, but they'll keep it separate from all their other operations.
Gary
Please correct me if I'm wrong. I see DCVax-L as one product and Keytruda as another. If DCVax-L is more effective when used in combination with Keytruda, I don't understand why that would extend Keytruda's patents. When it's patent expires, if Generic Keytruda exists, DCVax-L should be equally effective with it.
It would be very different if a new drug were created that combined DCVax-L and Keytruda, that would be one, entirely new product, lets call it DCVax-L-K, but it would require new trials and regulatory approvals.
Once DCVax-L is an approved product, I don't believe the company, or anyone else, can prevent it from being used with other approved products that are readily available to an Oncologist treating a patient. A trial that proves it effective with Keytruda shouldn't prevent a Dr. to choose a competitor Keytruda if they wish.
On the other hand, if Merck developed an improved Keytruda, that could get them patent extensions, but it would no longer be the same drug, it would have to be put through trials, and it would be a new drug. If I'm wrong about this, please explain why to me.
We all know that many new applications have been found for aspirin, I would suspect that Bayer may have been involved with finding many of the new applications, but I don't believe anyone is required to use Bayer's Aspirin in their treatment, though many still do. Costco's drug shelves are loaded with name brand and Kirkland brand products side by side. I've always found Kirkland brand satisfactory, but many people pay far more for the name brand products. Much the same will apply to the likes of Keytruda if a generic form is available, insurance may only pay the price of the generic, but if the consumer is willing to pay the difference, they can get it. It's equally possible that Merck drops the price to the point the generics can't sell at and keeps all the business, though somewhat less profitable to them. I suspect if Bayer wished to price their product below generic prices they could, but instead they attract those willing to pay more for the name brand.
Gary
I would think that drones could be the answer to delivery in places where very few deliveries are being made in an area of several hundred square miles. With charging stations being able to be strung out, delivery to one or a few locations that were hundreds of miles from a distribution center could make sense vs. sending a truck that distance to make a single, or a couple deliveries. I'm assuming that a carrier could be designed that housed perhaps a dozen envelop sized packages and delivered them in a specific order.
I don't know precisely how far the drone can fly before needing a recharge, but in that it can automatically land, recharge, and continue it's delivery, if a single, or few deliveries were hundreds of miles from the distribution center it might require several recharges in making one or a few deliveries, but it could do it with automated routing in which it left the distribution made it's delivery and pick up, if applicable, and returned to the distribution center and recharged in time to be recharged and loaded for the next days delivery. Essentially it could be working 24/7 with nothing than loading and/or unloading it, and setting up its automated routing once a day, all else would be done by the drone itself. It's not going to replace manual delivery where virtually hundreds of deliveries are being made in a few sq. miles inside a typical city.
Gary
After approvals worldwide, if NWBO hasn't yet undergone partnerships establishing higher value for the share price, like most other biotech's with approved drugs, NWBO's share price should become a function of the earnings from its sales. At this point it's impossible to say how long approval worldwide will take, I'll consider it worldwide after the 4 regulators we're working with have approved, as others will accept that without further trials, but we've not yet been given guidance on when the company intends to approach the other 3 regulators. I would certainly hope that by the end of 2025 we have worldwide approval.
If the end of 2025 is correct, the question at that time may be, is the available supply of DCVax-L equal to the demand for it. If it is, than earnings could be exceptionally high by that time, but if not, earnings would be limited to the company, or more likely it's contractors, ability to make DCVax-L for every patient that wants, and can pay, for it. If at that time it's largely brain cancer, it's possible, but if off label many cancers have been determined to be successfully treated by DCVax-L and insurance coverage is available, the demand could easily reach millions of vials of the personalized vaccine annually. If the EDEN is producing 50 vials a year, think of the numbers of EDEN units that will be needed, is it possible to build that capability that quickly. Frankly, even if we're unable to meet the demands at that time, the fact that demand is that great ought to indicate that our P/E will be at the high end of the range, perhaps even over the 30 X that's normally considered high.
I don't know where we'll truly be by the end of 2025, we could have been bought out before, but if we have worldwide approval by then, and if we have extensive off label use, I think we have every reason to believe our share price will be well up in double digits, if not in triple digits.
Gary
If I'm not mistaken, any company taking a 5% or greater position in a company must file that they're doing it. Can you imagine what would happen with the stock if a BP on major Institution announced 5% ownership in NWBO.
I frankly believe that ultimately there will be collaborations on trials between NWBO and BP's and part of the agreements, which the BP's may pay NWBO to do, may have provisions for future stock buys based on the price when certain milestones have been achieved. In short the BP equity partners will be buying at prices that are substantially higher than the price when the collaboration is initially announced.
Gary
Hank,
You're right about SGEN not being comparable to NWBO today, but if we're right about the DCVax's working in many solid cancers, the $2 billion SGEN is earning will be a tiny percentage of what the DCVax's are earning. We just need to be patient enough to let NWBO demonstrate what it really has. IMGN should have been worth at least half of what SGEN was, and in time probably more, but they sold out for about 1/4 of it. Be wary of selling out too soon, IMGN certainly did IMHO.
Gary
I agree Barnstormer, I have never seen a filing for a cancer or other deadly or debilitating problem not get priority review. Also agree that in the few legal cases I've had, the lawyer received more if it went to court.
Gary
Any products aimed at deadly diseases gets the accelerated path, it is as simple as that.
Gary
When the company files a BLA the FDA will set up a PDUFA date 6 months after they accept the filing. It's very possible that they could approve in 4 months or more, but if it goes down to the last day it's probably equally likely to be a CRL. The company would need to comply with whatever is in the CRL and then resubmit and get a new PDUFA date. I join others in believing that once we have UK approvals the others will concur once everything is properly filed. In that I believe the EDEN unit will be used for commercial production here, having it ready for the entire production facility to be inspected may be the key to when a BLA can be filed. I believe that at least initially, the CRL Memphis facility will be where NWBO licenses for the production of DCVax-L in the US.
While the company might receive more if their case went to trial, it could take substantially longer, and of course the attorney's will get a greater percentage if they go to trial. If a settlement was agreed to before NWBO had sales revenue building up it could give them the funds needed to accelerate many things.
Gary
I agree with all you're saying Biosect, but I must admit delays caused by the FDA in the past have certainly taught me not to bet on what they'll do. In time I have no doubts, the only question is, how long will it take.
In IMGN's case, on both Kadcyla and Elahere they had results they could have deemed worthy of approval, but they didn't. More trials were demanded and that adds years and many millions to the costs. I do believe they've changed a little since then, today I'm inclined to believe they'd do a conditional approval but insist on a confirming trial. It's a far better solution than no approval at all, but I still believe it would be completely unnecessary if after approval all applications of the drug were reported in a Phase 4, something easy to input if the expected outcome is seen, but in greater detail if something unexpected occurs. We all have to realize we're treating people who're fighting deadly diseases, so deaths will occur. The big thing I see a Phase 4 doing is allowing others to see that it's been used off label in certain diseases, and evaluate the results reported to date. I believe Insurance would have problems denying use if say 20 patients with a given type of cancer had off label treatment and the majority had positive outcomes, and no unexpected problems.
Gary
I certainly hope you're right. Working with the DOD is not that different than working with Costco, if they drop you it can practically put you out of business, but if they select you and keep purchasing, the growth can be tremendous.
If the Govt. likes what Epazz had developed in this drone, they very well could ask them for larger, or smaller units that utilize the same technologies. Govt. contracts are generally competitive, so if the quantities they're asking for get dramatically bigger, the competition could increase. I believe that if they're selected in a competitive contract to build a certain unit, if more such units are ordered, it shouldn't require further competition to award.
It's very possible that parts of the payload packages developed for the military may not be available to all, or certain, other countries, or to the general public. One of the biggest advantages of the drone, as I understand it, is the variety of payload packages it already has, or that can be developed for it. Some time ago I read about tiny drones that could be launched like killer bees from a jet fighter. It would seem to me that our larger drown could easily have a payload package that included a launcher for these tiny drones. As I understand it, each of the killer bees has facial recognition capability, on recognizing a target, just one of them can take out someone who's targeted. I'm uncertain, but suspect that they self destruct at the end of their flight. If such packages are being carried on our drone, I very much doubt if we'll ever learn about it.
Gary
It's been a few years since I first invested in NWBO. At that time I believe that many of those bashing the stock truly believed the technology had no chance of being approved. Over the years I think that many of the biggest doubters have changed their mind about never gaining approval, some say UK, but not USA, others have differing opinions, some believe additional trials will be needed. My point is, many who said no or never before are now saying maybe, some still say not the FDA, but more seem to concede that after the UK is proven, others will start to fall in line.
I don't know what the legal settlement may bring, but one thing is certain, if the Judge sees it as a valid case, no one can deny that NWBO could have generated all the funds they've needed with a tiny fraction of the shares they've needed to sell because the price was driven so low. I wouldn't be surprised if the Judge finds in NWBO's favor if the MM's almost immediately made a settlement offer to avoid a trial. Clearly they might get more if they go to trial, but I believe what they bring in would have greater benefit if they had it soon, over a trial which could be delayed a couple years, but provided more money later. Certainly I doubt if NWBO will take the first offer, but if they wish to settle, I think it will get done.
If a settlement and UK approval came in at roughly the same time, NWBO would not only get a huge boost in the share price, they'd also be well positioned to operate for years without either BP partnership, or buyout. That doesn't mean it doesn't happen, it means that NWBO is in a better position to achieve a much better deal. BP's love nothing more than circling a struggling biotech like vultures and swooping in for a penny on the dollar. That doesn't happen when the biotech is on strong financial footing. NWBO without a settlement will be on steadier footing because of the higher share prices after UK approval, but they'll still need to dilute until the revenue stream fills in.
Where we go after UK approval is largely dependent on events planned beyond the UK. I believe when we have the Annual Meeting we'll learn the status of the EDEN unit and the company's plan regarding approaching the other regulators. We also should learn about the new trials they intend to initiate in the foreseeable future. All of this will play into the where the price goes during the remainder of the year, and that price may play a big part in determining when a partnership or buyout is achieved. With few exceptions, the partner or buyer won't pay more than twice the share price at the time to do so.
After the UK approval it will be interesting to see how many who previously said you'll never get the FDA approval change their mind.
Gary
I know in IMGN and others insider trading isn't permitted much of the year because they have insider information. They don't publicly announce such periods, or when insiders can buy, or sell, but it normally becomes apparent. Insiders often receive so much in options, as incentives, that they rarely purchase on the open market. I believe that too much is made of insider trading, but it's influence can't be denied.
One announcement of funding on one of the DOD contracts and we could be trading at an entirely different range.
Gary
If I were a BP considering the acquisition of NWBO, I would not integrate it into any current production facility. If I wished to take on all DCVax-L production, I would either purchase the facilities currently doing it, or build an entirely new facility. I would treat the company as an independently operating wholly owned subsidiary. Why? Because making individualized vaccines, storing them cryogenically and distributing them as needed is a completely different business than anything else any BP is doing.
Merck has been shown to be building a huge vaccine facility, but it's clearly for mass produced vaccines. Can you imagine integrating vaccines where one vial is for one patient and must be distributed individually at the time they're to be used for say one million patients in a facility that's also making specific mass produced vaccines by the millions. I believe the result would be chaos.
Any BP purchasing NWBO could bring in their own management, but keep it separate from their mass production vaccine and other product operation, these are very different animals.
Roche is probably the best example I've seen that purchases companies but keeps them operating as wholly owned subsidiary. Not only that, but Roche has also spun off companies like Genentech, always keeping a majority interest, they reacquired them. If they wished, they could do it again. I don't know that Roche is interested in NWBO, but it could be a good match if they were. I have no idea how many BP's have existing products that would be effective, like Keytruda, with DCVax-L. I would suspect that others besides Merck may want to partner with NWBO in new trials that combine DCVax-L with their products.
I'm frankly unsure, but I believe that after approval, if company X wished to run a small trial combined with DCVax-L and NWBO didn't want to co-sponsor the trial with them, company X could purchase DCVax-L for the patients in the trial. I don't believe this possible until DCVax-L is approved, but once it is, I don't believe the NWBO could say no to a company, or research institution running trials with DCVax-L they're purchasing in the commercial marketplace. That stated, I believe that after approval NWBO will be co-sponsoring many trials, and independently sponsoring a few.
Gary
Like just about every other stock, it's ultimately about earnings or potential earnings. The drone certainly represents something that could have major sales. I really can't speak for the other things the company is working on, but would like to hear from others who can. Dilution is something that virtually every company without substantial earnings does routinely, and many companies with substantial earnings still dilute as they want to grow faster than earnings alone permit. No one likes dilution at these prices, but if the choice is to do so, or go belly up, dilute.
Gary
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