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In the world of drones, so many types exist that we really can't say what compares with what. Some drones are the size of small aircraft and fly on and off aircraft carriers just like manned aircraft, some are as tiny as a ladybug, or smaller. My point is that our drone does certain things, and does it well. I believe the technology involved could be adaptable to both larger, and smaller drones that have similar capabilities. I don't believe that our drone is competing with those that are weapon systems from major defense contractors, but if the DOD likes what they're seeing, a major defense contractor may want to either partner with, or acquire the company. Either way, investors would come out very well.
I would suspect that with the right payload, our drone could spot incoming drones or other weapons over a substantial perimeter in time for action to be taken to prevent damage. Whether it's at sea, preventing an attack on a ship, or scanning an area around a military base, or surveying a border for approaching aliens. My point is, with just a few drones 24/7 protection could be established over a substantial area and with a variety of payloads. I doubt our unit would carry offensive weapons, but it would permit them to be targeted right on whatever they're tracking.
Gary
I agree with you. If the company is bought out, it will be to someone who guarantees that the science they've developed continues to move forward. It would not surprise me if they became a wholly owned subsidiary of the buyer, and if both LP and Dr. Liau were assured of remaining involved for years, or perhaps as long as they wished to be.
Frankly I believe that LP would prefer a partnership to a buyout, but of course I could be wrong about that. It would also be very possible that she'll do nothing for at least a year or two, by then she could have DCVax-L approved all over the world and DCVax-Direct well into trials. A buyout at that time would not only bring in far more, but the success of the vaccines to date would assure that their use would continue growing ever more rapidly with the support of the buyer. It's very possible that they buyer would also partner with NWBO at an earlier stage of the companies development, perhaps as early as just after the initial approval of the vaccine.
We ought to be about a week from when the Annual Report is issued, it's hard to say if anything really new will be found in it, or not, but it at least gives the company an opportunity to provide some new guidance. We'll see if they take advantage of the opportunity.
Gary
You could be right, but I believe that we can submit the BLA without having a BP partner, in fact I don't see it as mandatory, but desirable.
I believe that CRL could be a partner, who're not considered a BP, and they could bring in billions and be responsible for distribution everywhere in the world except the UK where Advent would cover.
Gary
I've listened to the webcast and looked through the quarterly, it looks to me like things are advancing nicely. Apparently more was anticipated as the stock was down dramatically after hours in reacting to the quarterly. Sometimes it's foolish to think that sales growth will simply go through the roof instantaneously. $1 billion in earnings should be worth a market cap in the $10 to $30 billion range, if it takes a few years to get there as I see it, the company is moving in the right direction.
Gary
Kab, the agreements between NWBO and Advent/CRL could be structured in so many different ways that it's impossible to say what they'll be. As I see it they will make, store, and supply as needed every batch of vaccine that's ordered. NWBO could either be paid for these rights, or pay for them, if they're paid Advent/CRL will make more from each batch, if they pay, NWBO will receive more, the point is, it's a balance, NWBO will be in charge, but they can structure these agreements in the manner they choose.
I suspect that the framework for what will happen has already been agreed upon, but it cannot be implemented until the EDEN has been approved for commercial manufacturing. I don't believe the EDEN will ever be sold, it will be leased and NWBO will be responsible for its maintenance and any updates. Software should track every disposable cassette so the company is tracking every new vial of the vaccine that's manufactured by either of the contractors.
I certainly believe that the lease of each EDEN unit will bring in some payment to the company, but as long as demand for the vaccine grows, the cost of the lease will be recaptured after just a few doses have been made with it, and paid for. The production of EDEN's ought to be either profitable, or no worse than cash neutral to NWBO. Production of the vaccine will clearly be profitable.
My point is that NWBO can be very flexible in how these things are developed, they certainly could still go other directions, perhaps with a BP, but I believe they'll do it with Advent and CRL at least in the beginning. As for monetary concerns, once the share price is in dollars, generating hundreds of millions through stock dilution isn't nearly the problem it is today.
Gary
Frankly the company hasn't yet given the investment community a reason to want to buy NWBO stock. We've put two and two together and see the reason, but the greater investment public has never heard of NWBO. This condition won't remain forever, at some point we'll get major media coverage and suddenly almost everyone will hear about NWBO. I wish I could say when it will happen. It's possible the article in Nature will touch it off any day, or it may take the UK approval. I really don't know, but at some point the fact that we have a vaccine that potentially could improve the treatment of nearly all solid tumors will be heard by the investment public.
All of us investing, or bashing here know nearly everything the company does or says, but others simply do not. I've certainly told many who haven't gotten in. Why? They simply don't believe in investing in stocks selling this low. I'll practically guarantee that when the stock is $5 or more and trading on a major exchange they'll ask me, was NWBO the stock you were telling me about when it was $.50. They'll be buying then, while we'll already have a ten banger.
I just don't believe that you can keep the message down, but I don't know what will bring it out. Nature by itself won't, but if one of the major network sees the story in Nature and puts it on one of their major news outlets, like 60 Minutes, or even in the national nightly news, that could certainly be a triggering event. Once triggered, it won't stop. The more investors look into NWBO the more they'll want to have a piece of the stock, perhaps to the point that it takes us to a market cap that really can't be justified.
I'll be the first to say that by itself DCVax-L isn't curative, but with the right combination of therapeutics it may be. The thing I believe can be said is that with essentially all solid cancers it has the potential of improving the outcome for the patient. Certainly in some patients it will be better than others, but we have a vaccine that may make the difference between a cure, or not, but at this point it's not yet possible to say who will get the maximum benefit.
I'm certainly no medical expert, but it's not been that many years that we've learned about T-cells, CAR-T, etc. Now it seems like we're learning about many types of T-cells with some companies developing new therapies with certain T-cells. What we know is that our vaccine expands the T-cells that are naturally fighting the cancer in the patient, not some selected T-cell that a company picked. Can you imagine a network asking the question, what's the best way to fight cancer, is it specific targets selected by a company, or is it to use the cancer to make a vaccine that identifies all that must be fought in the cancer. I believe the answer will become obvious.
Gary
Kab,
I suspect that deals that formalize CRL and Advent as being the primary supplier of the vaccine worldwide and leasees of the EDEN units to do so are ready to be signed, sealed and delivered, but await one singular event, the acceptance of the EDEN unit to commercially make the vaccine. Certainly I could be wrong about this, but I believe that's how the company is planning to operate.
Sawston already can make the commercial vaccine manually, but capacity is quite limited and while some may disagree, I don't believe it sufficient to satisfy FDA requirements. I'm frankly uncertain if European and/or Canadian requirement could be met with Sawston as is, nor do I know if language already exists with Advent on using the EDEN when they're approved for use.
Hopefully in either the Annual Report or Annual Meeting we'll get further guidance on this, the recent announcement on the EDEN is a positive, but still leaves us unsure of how much longer it will take. If I'm wrong, if sufficient suites of cleanrooms would permit FDA acceptance of the facility, then an FDA filing could be made at any time, likewise the other regulators. If I'm right, all but the UK may await EDEN acceptance.
Gary
Smitty, I know many disagree with me, I'll agree with you that the BLA is near completion, but production will require the EDEN and until it's within a matter of months of being approved they'll not file. When the EDEN is ready, I believe it will be leased and licensed to both Advent and CRL who'll be contracted to do nearly all the work related to distributing the vaccine all over the world as new countries are added to the list of those approving the vaccine.
It really won't take that much larger a staff to operate this way. The company itself will largely be involved with new trials and products while the other work will be done with contractors.
Gary
ATL, you are right on the money. Furthermore NWBO has contracted for so much of what has been done to present, there is no reason why they can't continue operating in that way.
I still believe that CRL could play a big part in their future and could take on much of the tasks unless a buyout ends everything.
Gary
While I'm new to this company, investors in NWBO have had a few similar situations. The submission was known to have been made, but the journal was not identified. We waited many months and finally it came up in JAMA Oncology, a publication that none of us had guessed at. The draft of anything article that should appear in Nature was seen many months ago, it still hasn't published, and no one seems to know when it will be. My point is don't disparage, it will happen in time and I believe it's correct that the company will learn of it slightly before it comes out, but probably can't say anything until it's out, but they can be prepared to discuss it then.
Filing for approval is a different matter, the company has at least some control over that. Contractors may be used for certain aspects of it, and they can't always control them precisely, but they have some control, and if the application is undergoing rolling review, they have an opportunity to fix anything the regulator suggests changing. I don't know if they've ever revealed doing a rolling review, but as I understand it, corporations are not supposed to announce that they're in a rolling review.
Gary
I'm curious, what would you put in the EDEN unit to make a vaccine to fight a virus?
Gary
I'd like to hear others thought on the IOVA drug.
Gary
IOVA's used patients cancer cell to treat melanoma and received approval for their drug which is made that way, here's a linK:
https://www.msn.com/en-us/health/other/cancer-therapy-approved-by-fda-uses-body-s-own-cells-as-a-living-drug/ar-BB1iC2PM?ocid=hpmsn&cvid=20f0bb4eff6a4975a19e3df381ced186&ei=8
I don't believe it's personalized in the same way, but it should be of benefit in that the regulators are accepting the concept.
Gary
Hyperopia, what I've liked about Roche in the past is that they'll buy a company, like Genentech, then permit it to operate somewhat autonomously as a subsidiary. Frankly that's the way NWBO should be operated if it's purchased by a BP, if they have other personalized products, they could be combined, but operation of personalized products and mass produced products together could be very difficult for both.
The day may come when many products are personalized. When that occurs, I'd suspect that regionalized centers that produce many personalized products could be established, somewhat like the compounding pharmacies that can make specialized prescriptions not available in bulk. Of course such facilities would be larger, but not as plentiful as compounding pharmacies. With all their facilities, I could see CRL performing such services in the future for many different personalized product developers.
Other major BP's are operating in the same way, in it's buyout of IMGN, ABBV indicated IMGN would operate as a subsidiary, we'll see if they maintain that position over time. The big question in any such buyout is the attitude of the buyer. Do they want to put money into the company they purchased, and build it's product line, or do they want to essentially only grow the already approved products and abandon the rest, taking all the money they can out of it. Once again, I believe that Roche has assisted its subsidiaries to grow.
Partnerships or buyouts are a part of the game, I'd prefer one or more partnerships to being bought out. A partner that takes equity that represents 20% of the company, or more, has a great deal of influence over the company. They would probably get a seat on the Board, and allied with Institutions they could be hard to stop in a shareholder vote on any issue they insisted be put to a vote.
Gary
I've just taken a position today. I would suspect that if revenue is increasing, the way I've been told it is, they won't be able to hold it down that long. If I remember correctly, they report later this week, let's see what happens then.
Gary
With success demonstrated by UK approval and a dramatically higher share price, I believe that either Nasdaq or NYSE would welcome NWBO provided they meet exchange requirements. The Nasdaq could probably do it for less, but that would be up to them.
Gary
You're right, I'm so used to writing about biological products I hadn't thought about it. The process is largely the same, but NDA it is.
Gary
I think we all tend to place different value on the potential because we're thinking in different timeframes. If I'm speaking about this decade, reaching hundreds of billions is possible if the tumor agnostic label comes before then. If we remain independent and gain the tumor agnostic label for both DCVax's, it won't take two decades for us to reach a trillion dollar market cap, or higher.
I'd love to live long enough to see a trillion dollar market cap, but doubt it, but hundreds of billions is very possible if the company isn't bought out.
I failed to buy AMGN back when it's market cap was probably a few million, you never know how big a company may go if it isn't bought out. Sadly, most of the biotech's developing the best of the newer technology do get bought out. BP's make a case for keeping prices high to support new drug development, which is very expensive, but they do little of it, they let the tiny biotech's do the real work, then purchase those that are successful most of the time. AMGN is one of a very few that grew from a tiny biotech into a giant.
Gary
If it's to be commercially viable, it needs to be enjoyed by the audience.
In a music class the question of what is perfect music. It was determined by the instructor that if you had perfect music and had a series of notes established, perfect would be if everyone selected the next note, and they were all the same. They won't be, so the point was that perfect is different to every one of us. Music, like many other things, doesn't need to be perfect, if it's enjoyable to the listener, that's sufficient.
As a senior, I really don't like some of the newer forms like rap very much, but some of it I find entertaining. I think if you look at the Music Man, a little bit of it could have been called rap, or close to it.
Gary
I certainly don't know it can't be done faster, but I believe that most new trials require half a year or longer to initiate from the time an IND is first submitted to one, or more regulators. I believe acceptance from the FDA is still presumptive, you can proceed a fixed number of days after submitting. Then you need approval of the IRB of the organization where the Lead Clinician is working. That's where the trial protocol undergoes serious development. I won't say it must total a half year or longer, but my experience has indicated that it has in the past with several companies.
That stated, if NWBO is intending to initiate one or more new trials this year, with or without partners, it behooves them to have the IND's prepared by mid-year. If partners are to be involved, clearly that must happen before IND submission. I don't believe that such partnerships will be formalized until UK approval has been seen. Once that occurs, things may start to happen in a real hurry.
One question I'd ask is, at what level will new trials begin. It's my belief that between what's been done at UCLA and elsewhere on solid tumors it would be possible for new trials to begin as Phase 3, or perhaps registrational Phase 2's if they attempt approval out of a smaller trial. Of course the regulators must approve whatever is proposed. The question which may, or maynot, still be an unknown is whether pseudoprogression is known to exist in other solid cancers. If it's not known to exist, then they may shoot for a shorter trial that's PFS based as the primary goal, OS being secondary. If it exists, clearly OS should be the goal and PFS completely ignored, it's a longer trial, but depending on the cancer, the goal could be evaluated in just a few years if very deadly, like pancreatic. If trials were being done in far less deadly cancers, like prostate, many years of data could be needed. Hopefully demonstrating efficacy in a couple of the deadliest cancers can result in a tumor agnostic label for virtually all solid cancers.
Gary
I'm a new investor in ANVX but have decades of investing in biotech's. It's my belief that the contents of what has to be submitted to a variety of regulators is well over 90% identical. Once an MAA filing is ready you have over 90% or what will be needed in a BLA or other filing. Regardless of who they file with first, they're 90% or greater ready for one or more of the others.
I'm a NWBO investor and they're going for the UK first. I believe it's largely because they have an approved commercial production facility for manually manufacturing their vaccine in the UK. Their MAA was 1.7 million pages, to me nothing should require that much paperwork, but I really don't believe the other regulators are very different. If you really want to bring down the cost of approvals, the decimal point should move at least a couple of places to the left.
Gary
Doc,
I do believe that a BLA won't be filed until the company feels certain the EDEN unit can be used for production, but I believe that they could do it while the EDEN is still in the process of being accepted. I say this because from the time the BLA is submitted there is roughly a 7 to 8 month period, a month or two in accepting the BLA then establishing a PDUFA date 6 months later. The inspection and acceptance of the commercial production facility can be scheduled near the PDUFA date, if the company's course to approval of the EDEN is say 6 months or less, as long as they're timing was correct, the EDEN's could be in place and accepted before the full facility is inspected.
I do expect NWBO to use CRL's Memphis facility for US production. If I'm right about that, I believe the facility is essentially already approved and working for other products. Sufficient EDEN units installed in the facility may be all that's really needed. I believe that CRL and NWBO will release information regarding their relationship once the time is deemed to be right.
Gary
Chiugray,
I believe that once we have UK approval, regardless of whether the price rises to $5 or not, Institutions will be coming in. Some Institutions can legitimately get in at $1 or $2, but many others that need $5 or more will get in anyway at any time after the beginning of a quarter. There hope will be that by the end of the quarter we're at $5 and if we're not they'll sell at the end of the quarter, and rebuy at the beginning of the next quarter. Institutions only report stock they hold over the quarter, even now some Institutions may be investing, but barring our reaching their minimum by the end of March, they'll sell at that time, and they purchase back in April. The MM's are only too happy to work with them in such efforts.
We live in a world where Institutional investment could be electronically reported essentially instantly, instead, reporting requirements remain 45 days after the end of the quarter so we're half way through the next quarter before they must show their holdings. Gains and losses that occur from stocks not held through the quarter are simply combined and reported as a single figure. I've been told that many Institutions invest substantial portions of the funds they manage in stocks that are completely outside the charter of the Institution, so even if they have a huge gain in a stock, if the stock doesn't belong in their portfolio it's never held over the quarter.
I believe UK approval will signal many Institutions that probably have been watching NWBO for years, perhaps over a decade, that it's time to get in. Some may do so before the approval, in anticipation of it. Let's watch the trading in early April, heavy volume might indicate Institutional buyers anticipating approval before the end of June.
Gary
Looked it up and MacArthur Park actually describes Jim Webb, the songwriter's breakup with his wife, which all revolved around the park. When you think about it, some really great songs are meaningless. I think Neil Diamond has an amazing record of taking on something senseless and turning it into a song, best example, porcupine pie. I like the music, even if it's senseless.
Gary
Out of curiosity, I've seen a number of credible posters using July/August as when they believed approval would come, why? With a filing in December and a 150 day target, that should put the decision no later than early June, but to me April or May is most likely if they have no problems with the MAA. Frankly if there are problems they frequently take more than a few months to resolve, at least they would if it were the FDA. I really don't know how much faster things could work with the British.
I suspect that if there are issues, they may be resolved right then and there and not delay the 150 day target at all because I'm thinking the company is working closely with the regulators so problems will be resolved on the fly as long as they're minor in nature.
Gary
If the Judge accepts Posner's submission and doesn't dismiss the case, hasn't the Judge already made the decision on guilt or innocent's. Certainly you can't put a price on it, but the proof that spoofing has occurred and cost the company and it's investors money will have been established.
Gary
Thanks, I should have realized that, the only way to prevent that would be making it a rocket engine with the addition of liquid oxygen. I've not kept up with advances, but years ago it was thought that carbon nanotubes would be used in fuel cells and greatly reduced their size and weight, anyone know if they continue to work on that. Frankly there are an unbelieveable number of uses for carbon nanotubes if we ever gain control of that technology.
I would suspect that if an aircraft, ship, etc. needed peak power of say 1000 h.p. but was intended to cruise at say 500 h.p. the fuel cell ought to be capable of providing say 600 h.p. continuously with batteries used to boost the power as needed, then recharge while cruising. Of course I could be wrong, it may not take that much weight or size to go to 1000 h.p. continuous power as needed from the fuel cell alone.
An electric turbo jet would be a very different animal, but compressing the air dramatically should certainly heat it and have it expanding dramatically in the nozzle without the addition of a fuel or any combustion. I'm uncertain if the heat would be great enough to create NOx. I really can't say that propellers wouldn't be utilized in subsonic flight, the props would probably be toroidal and very different from anything on aircraft we're used to seeing. I don't believe props can be used to achieve supersonic flight, but I could be wrong.
Gary
I don't disagree with this, my question simply had to do with which would go further on the same amount of hydrogen as fuel. It sounds like the answer should be fuel cells. If true, that should also apply to aircraft where electric fan jets or propellers should go further than hydrogen fueled turbo jets. Electric aircraft should be substantially quieter and less costly to maintain. I don't know if it will be possible to develop sufficient thrust to create high performance military aircraft capable of over mach 1, but if it's possible, no telling how far this could go.
I'll certainly admit, I hadn't thought of fuel cells being able to operate at the power level required to power a commercial aircraft without themselves being very massive and heavy, if that's possible, perhaps in combination with batteries to boost the power when needed, it should be the answer to non-polluting commercial aircraft. I would think the water produced by the fuel cells could even be used for drinking in the plane. The same would be true in ships, yachts, etc.
Gary
CO, while essentially I agree with you, I put the odds of approval at over 90% only because of some of the other errant decisions I've seen from the FDA before. I've yet to be wrong about a product I felt was certain to be approved, but on more than one occasion the FDA asked for something more delaying approval by at least several months, and in a few cases years. Lives were lost in those occasions too, but that's how they operate.
The worst case, IMHO, was a drug aimed at a rare condition that was deadly in premature babies. The drug as produced didn't meet their shelf time requirements. They could have approved the drug, limiting it's shelf time and giving the company time to correct it, but they didn't. It wasn't approved, babies died, but well over a year later the shelf life problem was solved and the product approved. That was years ago, I think it may have been handled differently today, but my hesitancy to say 100% is because of witnessing decisions like that in the past. The other regulators may be a little better than the FDA.
A few years ago 60 Minutes ran a story on American Drs. who've set up practices in offshore hospital and recovery facilities that were truly 5 star in quality. They did so because there they could use products to treat their patients that were not available in the US and save the lives, or provide higher quality of life, to patients willing to go offshore for the treatment. Recovery was in nearby 5 star resorts until they could be released to go home. The costs generally were less than treatment here, but few if any insurance companies were paying at that time.
It will only be a few more months until we learn what the UK will do. I suspect the others will follow the UK lead on approval, but the company may not submit until the EDEN is qualified to make the commercial product. Share price post UK approval may have much to say about how quickly other trials can begin. No doubt the company will need money, dilution when we're trading say over $5 is far less impactful than doing so at just over $1. Much will depend on how the company is viewed by The Street once we gain that initial approval. I would hope that approval leads to LP and others representing the company making appearance in many brokerage and Institutional conferences, doing quarterly webcasts with questions from Analysts, etc. In short, they need to publicly fight to get NWBO's name out there, not hype, just an honest discussion of what they've done to date, and what the future could hold.
Recently the pictures taken at SNO I believe featured Tumor Agnostic on their display, could you imagine a picture of Dr. Liau and/or LP on the cover of Time magazine in front of a display suggesting that DCVax-L is tumor agnostic and the accompanying article supporting it. In time that's a possibility, and if things break right it may not take that much time. It all begins with UK approval.
Gary
It's my belief that pricing hydrogen today can only be based on what it costs to make and distribute it. In the future, if the promise of things like green energy and fusion come to fruition, that price could be substantially reduced. A huge sized solar and/or wind farm would both supply electric power to the grid, and excess power used to produce liquid hydrogen for fuel cell and other applications. The initial costs are high, but once paid for little maintenance is required so costs can come down dramatically from today's prices. The thing that should be avoided is producing liquid hydrogen with electricity that's petroleum based.
I doubt if I'll live long enough to see green power being used everywhere, but I believe it's the future. In my own home I've added solar and a heat pump for heating and cooling, and I'll add a two-way charging system that will use the batteries in an electric car I'll acquire later this year to back up the power to my house. As of now I'm waiting for the 2025 Mustang Mach E to get the long range faster charging battery that won't be available till then, I've heard it will be out around summer of this year.
Gary
I'm not asking for a comparison vs. gas or diesel, I'm asking about how much hydrogen is used to perform the same task if I have a V-8 that runs on hydrogen vs. a fuel cell that's doing the same. There is no doubt in my mind that in certain applications hydrogen is a better solution than electric power from batteries, but if the choice is between internal combustion and fuel cells, which is superior. Hydrogen used in an internal combustion engine or fuel cell both result in water being produced, so it's green energy either way as I understand it.
Electric aircraft are being discussed, if battery powered, clearly electric motors would create thrust through propellers or turbines. If hydrogen powered, the question is are you better with a fuel cell providing power to an electric motor, or a jet engine that's powered by hydrogen instead of JP-5, etc. I don't know the answer, does anyone here.
By the way, if hydrogen fuel cells are to be successful in cars, if something like a 300 mile range was to be the minimum for any car, has anyone estimated how many fuel stations would be required nationwide in order to be able to drive anywhere that you could currently drive a gas powered car. I would suspect the number would be in the tens to hundreds of thousands, or more. Without that capability, can fuel cell cars be a viable competitor to batteries when newer batteries can be fully charged in under 20 minutes, and possibly substantially faster than that. I view it as being very viable for long distance hauling trucks and fleets of delivery trucks, etc. where fuel sources can be far more spread out, or centralized for an entire fleet, but question if sufficient stations will ever exist to make it viable to people who want to be able to drive where they choose to. On the other hand, where electric infrastructure isn't adequate, I see fuel cells being set up for car charging stations where a single fuel calls can charge possibly thousand of cars before it's large liquid hydrogen tank requires a refill.
Gary
I appreciate all the speculation on who may acquire NWBO in time, however, in purchasing NWBO I do so based on what I believe the potential of the company is. If by chance we do get a buyout, probably at something like twice the current price at the time, I'll certainly happily take it, but fully believe it will be at a price that left independent we'd achieve in time, then go on to much higher highs.
Our satisfaction with a buyout should have to do with our expectations. Most here, I believe, are looking for $20 a share, or more, based on what LP has been quoted as saying. I believe we'd all be very profitable at $5, but I really don't think most of us would be very satisfied with that, even if it came in the next few months.
We've all read about buyouts where billions were paid for products which failed, but they looked good in early stage trials. We have a product that is succeeding, that is a sure thing, but it's not impossible that the regulators could say, run the bigger combination trials and your sure of success. It would add years, it would cost many millions, if this were the case, a lower priced buyout, or partnership, might be something investors would welcome. We know we have a winning product, the only question is how long will it take us to get the wins.
I believe the UK will come through in just a few more months, but nothing is a guarantee. I am confident enough to be buying substantially more, probably tomorrow, but recognize that nothing is 100% sure. I'd put it at over 90% and I believe a UK approval will be worth a multiple of the current price. As for the spoofing case, it's the icing on the cake if it comes through.
Gary
Any thoughts about Roach? Over the years they have acquired companies like Genentech and allowed them to operate as wholly owned subsidiaries. I believe that has worked well for them.
Gary
From an efficiency standpoint, will a fuel cell deliver as much mileage as a hydrogen powered ICE with comparable performance?
Gary
Barnstormer, the idea wasn't to give an expensive gift, just something people want. I used to be able to get polo's for between $5 and $10 including embroidery, now under $20 is tough. I just hope that after some success NWBO is more open about speaking at Institutional and Brokerage conferences, hopefully with webcasts of at least some of them, and quarterly webcasts where Analysts can ask questions would greatly improve investor and Institutional interest in the company.
Gary
You may be very right Xena, on gaining initial approval it's very possible that the company becomes a buyout target, or one of the BP's wants to partner. I'd expect substantially higher prices, so if the company wanted to go it alone in new trials dilution could be reasonable, but no doubt a BP can bring greater funding in if that's the course they choose to take. They can also buy the company to kill the technology to keep advancing their own. The key is still getting that initial approval regardless of which regulator it comes from. Beyond that, success will either grow or the company will be bought out.
As I remember it, at one time you held IMGN, did you hold any into the buyout. I wasn't happy with what they got, but it did leave me with a healthy profit, I invested some of it here.
Let's hope that Anavex doesn't take nearly as long as IMGN to reach success.
Gary
What are you expecting to happen at 90 days? The evaluation period target for the MAA with expedited review is 150 days, 90 days might be the earliest any action could be expected, but it's certainly no guarantee. Remember their filing was 1.7 million pages, certainly not every one will be scrutinized, but I believe the company is asking for more than approval in GBM, or even all brain cancers, time will tell how much they get.
While all longs would love to see an early approval, it's foolish to count on it. 150 days puts us well into the second quarter, I'm fine with that. In roughly two weeks we should see the Annual Report, it's hard to say how much will be said there that isn't said in a quarterly, but they certainly have a vehicle that they could say more in. It's up to management as to how much they say, how much they wait for the Annual Meeting or action by the UK, the ball is in their court. We were given a heads up on the EDEN, but it was far from telling us when it should be available for commercial production of DCVax-L.
I would hope that any new trial utilizing DCVax-L clearly indicates it's made in the EDEN unit. I don't believe new trials will be initiated until we have at least UK approval, but anything is possible. From the time an IND is first filed and a trial begins is often many months, in some cases it can take a year or more. In IMGN's case, much time was taken because they wanted a specific Dr. as their lead clinician and a great deal of time was taken by him and the IRB to be available to start the new trial. If the next new trial initiated for DCVax-L isn't in GBM, I would suspect that someone with no current knowledge of DCVax-L, but with expertise in many solid cancers, would be selected to be lead clinician. That person might be from UCLA where Dr. Liau could assist, but I don't believe she'd act as the lead clinician of any such trial.
It seems to me that when we're discussing days, how many days are we into peer review by Nature into the article they're peer reviewing. I really don't know, but if we've learned anything it ought to be that such reviews take a lot of time, perhaps more time than the regulators allow themselves to judge a filing for approval. Nature's manuscript was submitted well before the MAA, what's the likelihood that we'll get approval before publication.
Gary
For those who couldn't read the continuation of the article, here's a link that may work for you.
https://enewspaper.latimes.com/desktop/latimes/default.aspx?token=42e23962a5d74614be16bae3d62d13e7&sfmc_id=6532a15825b3640666b604f8&utm_id=34390806&skey_id=64fdbe8caba24cda07d7606980b89d692e94d76ec9759ee279ef7066a3cacca8&utm_source=Sailthru&utm_medium=email&utm_campaign=ENP-email-Subs-eNewspaper-2024218&utm_term=eNewspaper+Daily+Notify&edid=cf90e1c1-e29c-4052-9044-af7b0f534877
While not specific to ANVX, with no mention of it, I believe it's still very worthwhile reading.
Gary
Doc, it's been many years but I don't believe anything has changed. A company I was invested in went on one of the Russell indexes, that meant that certain Institutions had to take substantial positions. The day they go on the Russell millions of shares trade after the bell at the closing price as MM's have been accumulating shares for their Institutional customers. At the same time a major short position opened up. That company stayed on the Russell for two years and that huge short position was maintained the entire time. When the company went off the Russell, the short position disappeared. My point is, legally or not, the MM's had maintained a major short position, several million shares, for two full years. I suspect the stock may have moved up nicely if they had to close their short position, but instead they essentially created millions of dollars worth of stock that the company was never paid for. I can't believe that the SEC doesn't see actions like this, but they only seem to care if someone makes waves about it.
I believe that if the Judge finds the spoofing charges valid, the SEC could start to take an interest in what was going on.
Gary
They really only mentioned a few companies that are common household names, they indicated many more companies were involved. I suspect that we were one of them. If we gain regulatory approval, you can bet in future articles that our name will be issued. I don't know when our filing will be made, or to which regulator for certain, but regardless, as long as we've filed during the first half of the year, we should have a decision this year. Certainly they can take over 6 months, but I believe they'll get priority review from any regulator and that should result in a decision in 6 months or less. Of course they all can create delays, nothing is certain.
Gary