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Abeta, very few trials give discernable data in 6 months, often not even a year. Why? Because not that many patients enroll in a trial that quickly and even the SOC often has patients living many months, often years on a variety of therapeutics. The reason so many trials last a decade or longer is that it takes that long to get data the regulators are satisfied with. Don't get me wrong, once you have an approval, it's probably faster to expand the label, but six months would be unusually fast IMHO.
Gary
I trade in a manner that's very similar to what you're describing. If I see a buy isn't taking I determine if I'm willing to pay more, than I'll raise it, or that I don't want it above the price I put in the limit at, then I'll just leave it in place. Option orders sometimes fill at one, or a few per day or week, on an order for 100 of them, sometimes I get them all, sometimes I will raise my price a bit, but I don't mind if I only get a partial fill if what I purchased is now worth substantially more than I paid.
I believe at some point after we're at least $2, probably more, options will be made in NWBO. I don't intend to sell calls until the stock is trading in double digits, but at that point I think it could be a good way to bring in pocket change.
Gary
One of my biggest mistake was Amgen, I first heard about it about 1990 for roughly $15, that was pricy for me back then, though I could have bought hundreds of shares, I preferred getting thousands of lower priced shares. Before I knew it the stock hit near $100 and split, I still didn't buy. By the year 2000 it had split a grand total of 48 to 1 and was back to around $100 again. It's done okay since then, but not nearly as great as what it did in that decade. I've still not ever owned it.
I still believe that my greatest success will come with NWBO and it could be bigger than Amgen, at least on a percentage basis. I frankly thought that IMGN could have such growth with successes in multiple products, but the buyout will end that possibility.
Gary
I've bought many times through Fidelity, I generally place the order at the ask or round up to the nearest penny as if I want the stock I don't get concerned about tenths or hundredths of a cent. I place limit orders generally GTC, but it's rare that I don't get it the day I put in the order for stock. It's very different for options, there the spread is often far apart and I'll put in an offer somewhere in the middle, sometimes it takes weeks or longer for the entire order to fill, occasionally it never does and if I really want more of the option, I raise my price.
Did you track the price, it's likely the ask went above your offer practically as quick as you placed it. If your order is GTC you'll probably get it on any weakness unless the stock is up dramatically from when you put it in, if that's the case, raise your price if you really want it.
Most of the time, I've found that Fidelity actually fills most orders below my offering price, but only by tenths or hundredths of a cent. I frankly preferred it when about the smallest increment between bid and ask was 1/32nd of a dollar, trading down to hundredths of a cent has made it lucrative for computerized trading which I believe can be more manipulative than when much larger spreads were applied, even for penny and sub-penny stocks. Perhaps sub-penny stocks existed back then, but I certainly wasn't aware of them.
Today I find many investors who just don't see where a penny stock moving from say a quarter to a dollar is far more lucrative than a blue chip, like Tesla going from $200 to $250, $300 or even $400, it would actually have to go to $800 to make the same percentage gain. Percentage gains is really all that investors should look at, if you get a 1000% gain it doesn't matter the price of the stock, only how much of it you own. Many investors I know won't touch a stock trading for under $1 or even $5. Many consider anything under $5 to be penny stocks.
Gary
Much the same has been true for conjugate drugs. Roughly 4 decades ago I invested in IMGN, the first company I read about doing MAB conjugates. It seemed like an elegant way of curing cancer, MAB's were being developed that homed in on the cancer carrying a effector molecule (poison) that should kill it. There have been some successes in the 40 years, but far more failures. The more they learn, the more likely the newer drugs they have in development will be successful.
I believe that much the same is happening with dendritic cells, the more they learn about them, the greater the likelihood of success with them. In IMGN's case, their first successful conjugate was called Kadcyla, but it was made for Roche by conjugating Herceptin with IMGN's DM1, but IMGN had a small financial position in that drug, and monetized what they had, rather than waiting for blockbuster earnings, which eventually came. Their first wholly owned success was Elahere, just approved last year, and in spite of building sales and other products advancing toward approval, management decided to cash in by selling out. After 40 years I'm nicely profitable, but not a happy investor.
I think that if NWBO is ever sold, it will be at a price that we're all happy with. Time will tell, but all I've heard about LP is that she gets it done her way, or it won't be done at all. Many may wish she operated differently, more openly, etc. but I really don't believe that many can honestly say that what she's done hasn't been for the benefit of the company in the long run.
Gary
If the military buys our drone, I doubt if you will see EPAZ on any of the pictures, it might be USAF or USN, etc, but it won't look like what is shown in the company pictures.
Gary
Erik,
Sadly if you look at those patients five years from now, only about 800 will be alive with the current SOC. With DCVax-L it goes to more than double, but add other available therapeutics and 50 percent or more can survive well beyond the 5 years.
Gary
That would be a good start, perhaps with a brief statement on where we are, and a procedure for submitting questions.
Gary
I believe you're right, and wrong at the same time. You're right about no named 60 day program, but in the past, the UK has been known to approve new products just after two months. I believe that such an approval is possible here, but it's certainly not guaranteed. Personally I believe it will be second quarter, but perhaps very early in that quarter.
Gary
The company previously stated that they'd say when the MAA was accepted. I believe that they can delay slightly to maximize the impact, but they committed to tell investors and I'm certain that they will.
I don't believe we'll ever learn whether they were asked to make some changes, or not. The longer it takes to get the confirmation, the more likely changes were requested, but I very much doubt that they'll ever say so.
Gary
LC,
I don't know if that article actually considers what I mentioned to Mike, patients on average living many times longer. Whether the article mentions DCVax-L or not, we know that it, in combination with Poly-ICLC and/or Keytruda, and perhaps other therapeutics, can take survival of 50% or more of the patients to 5 years or more, perhaps ultimately to being considered cured. I believe the numbers may need to be adjusted substantially upwards as patients live longer on sustained treatment with DCVax-L. I'm frankly uncertain if after initial treatment with multiple therapeutics sustaining the remission requires more than DCVax-L boosters alone over the years.
Gary
Iron Mike,
Today the average GBM patient lives only a matter of one to two dozen months. With DCVax-L combined with other therapeutics that number will go to 5 years or potentially far more. If treatment continues for many years with DCVax-L so will the money being spent on that treatment.
People living longer will simply spend more with BP's, as well as on DCVax-L, as whether we're actually achieving cures, or only significant life extension, that's why I don't believe they'd benefit from preventing DCVax-L from reaching the market. Will one or more of them want to purchase NWBO, very possible, but many BP's will benefit from GBM patients living many years longer.
I don't believe anyone here, and perhaps no one at the company either, knows precisely how DCVax-L will be billed or how NWBO will be paid for its use over the years of treatment. Certainly it's possible that they'll be a higher initial price for making the vaccine, but it's also possible that each dose will have the same price, regardless, the longer a patient who remains under DCVax-L treatment lives the more NWBO should make from that patient.
Frankly even $1 to $2 billion in annual revenue isn't terrible, by itself it would generate substantially higher share prices, but once again, a tumor agnostic acceptance for many cancers would be ten to a hundred times better.
I honestly have no idea how much my total leukemia treatment has cost, but before Gleevec my specific form of the disease would have been considered uncurable, so I'd probably have been dead nearly a decade ago. No doubt my treatment would have been far cheaper had I died, the same will be true of the GBM and other brain cancer patients who live longer and prosper. That's why the annual cost of treating the disease will be substantially higher, but once again, people living longer will pay more in taxes, insurance, etc. so there are many positives to consider in spite of the global market going up dramatically.
Gary
Sorry, I'm not in the market for the bridge, but perhaps a 2 to 3 bedroom unit there in time. I'm fine with the criticism, but really would like to hear what estimates I made are so out of line. Let's hear what you think the company will be earning after approval of DCVax-L. I will say that on a nice day, walking the Brooklyn Bridge is really quite enjoyable.
Of course you may be one of those here that don't believe that's possible, we're all entitled to our opinions. I know a lot of people who'll have to admit we were right when it is approved. Of course if we're wrong about that, it will be us that must apologize. We should know this year for certain.
Gary
While I agree the share price is embarrassing, I also agree with the poster who said we really have to look at market cap, but not with a figure of $200 million being a fair market cap. With a regulatory submission and a vaccine who's potential is blockbuster many times over annually, I certainly believe a market cap in the $.75 to $3 billion range is reasonable, we're currently below even $.75 billion.
Most companies approaching anticipated approval generally achieve market caps in excess of a billion if their product in consideration is deemed to have blockbuster potential. I really think we need to realize just how great our potential is. On GBM alone, worldwide we'd almost certainly see sales well into double digit billions annually, and earnings in billions. Worldwide sales will take time, but once we have the approval of the four regulators we're working with, it won't take that much longer.
Let's say we are earning $5 billion annually, and growing by $.5 billion annually, what would be a fair P/E. While I believe it could justify a P/E of 30, lets make it 20. That would make the market cap $100 billion. Let's go beyond the currently authorized 1.7 billion shares, and say we have 2 billion shares outstanding. That would give us a $50 share price.
I believe that this is a fair representation of where we could be in 5 years or less on the strength of GBM approval alone. 5 years, however, could easily be more than sufficient time to demonstrate that DCVax-L has benefits in many solid cancers, whether it has actual approval as tumor agnostic, or merely has acceptance of the fact that it works, and insurance companies are accepting it for at least some of the deadliest of cancers. If this is the case, just move the decimal point at least one place to the right. That would be a trillion dollar market cap, but it might take some time to reach that level, but it's the sort of potential we'd have here with DCVax-L being tumor agnostic.
If you believe my numbers are wrong, they're just my assumptions, please feel free to provide your own.
Gary
The application was submitted then, acceptance is another matter. At this point we can infer that some change was requested, but we really don't know. I have no idea the degree of the review before it's considered to be accepted, but it's 1.7 million pages, clearly not every one of them would be scrutinized, but certain ones would be, if some had recommended changes, the company would certainly listen and do what's requested.
One reason most companies don't discuss submissions is that investors don't know how much time may be spent in making changes the regulators believe necessary, or at least desirable. I don't think that many companies simply say, take it as submitted, we'll make no further changes. The changes may purely be a matter of opinion, but it would be foolish not to take the regulators opinion very seriously.
Gary
While I am new to the company, I have to believe that with major government contracts, far more than a ten banger is possible. No one knows if we're going to get a contract, but if they do, who knows how big it could become.
Gary
There is a problem with saying "Curing cancer" it's not one disease and it won't be cured with one, or even many different therapeutics, etc. Cancer represents virtually thousands of diseases, or more, as it's broken down. Drs. like Dr. Liau tackle a limited number of them and if they're successful some patients, not all, with a certain type will be cured. Over time, as her success increases, the percentage that she cures will increase, but it's very doubtful that every patient will be cured, in a certain number of cases the cancer will probably be to advanced by the time it's diagnosed, but in others she just won't have a therapy that works with that specific form of the disease in that specific patient.
Certainly Dr. Liau contributed in the creation of DCVax-L, and that may ultimately be used in many cancers, but I doubt if she'll be the one that's using it in cancers outside of brain cancer, her area of expertise. I don't doubt that she'll speak with Drs. who specialize in other cancers and probably will make suggestions on other therapeutics they should try with it for their form of cancer, but I doubt if she'll want to become expert at many other types of cancers.
Gary
Meirluc,
When Sawston was approved for commercial production originally, it was a different submission that did it. I'm uncertain if they wanted a change to that approval that it would be done in the MAA, or if they'd submit an amendment to the original submission. In my mind I'm guessing that before asking to use the EDEN, it would need to go through some sort of certification program, hopefully acceptable to all regulators. Once certified, converting existing facilities to it shouldn't be a major issue as the device is already certified. I have no knowledge of precisely how this would be done, but I would hope such certification is underway.
I believe that when the FDA receives a BLA and establishes a PDUFA date the FDA will send inspectors to the commercial production facility specified in the BLA at a date they'll established. By that time, if production will be done with the EDEN unit, it should already be certified so that the inspectors are checking the total production facility, not certifying the EDEN at that time. Of course this is JMHO.
Gary
I'm sorry you feel that way, I tend to look at it the other way, management has run the gauntlet successfully. Don't get me wrong, other management would have done it differently, some may have been bought out years ago, probably not for much more than we're trading at today, but a BP may have taken it to approval faster with unlimited funds. Others would have gone belly up. I believe the outcome management has achieved has us on the verge of tremendous success without having to sell off a part, or all of the company. Sure, massive dilution, but most investors have averaged down so they're very well positioned for the upcoming success.
I'd like management to be more open about what they were doing, but the key is, the company is still here and success is soon to follow. Many other biotech's I've followed are nearly as secretive as NWBO and frankly I don't agree with much that they've done over the years. I'll make a lot of money if the IMGN buyout goes through, but I believe the company is worth more than they're getting, and if they'd waited 6 months to a year for more revenue and trial results the buyout could easily be double or substantially more than what they agreed to in the rush to sell the company after getting the first approval of their wholly owned drug. I hope the buyout is defeated in a vote unless the offer is sweetened.
Gary
When people ask about the share price after UK approval I don't believe that it's possible to say what it may be over time. Certainly at first just approval itself should be worthy of well into dollars. In time it would become dependent on earnings from DCVax-L sales. If the capacity to make DCVax-L was unlimited, and the UK was the only place it was approved, cancer patients from all over the world might be coming to the UK for treatment, even if it wasn't subsidized in any way, unless they were a UK citizen. That won't be the case, but if it were, in the UK alone the sales could generate billions in earnings. I don't know that even if fully built out that Sawston can make that much vaccine with manual production.
Ultimately earnings, and earning potential, will have the greatest influence on NWBO's share price. I think we should assume that NWBO's outstanding shares will go to 1.5 billion or more, so let's say they're 1.5 billion. If earnings are clearly growing each quarter, a P/E of 30 would certainly be justified. For every $1 billion in earnings a market cap of $30 billion would be warranted. With 1.5 billion shares outstanding that's $20 for every billion earned.
Such earnings won't come instantly, and I don't believe that we'll be limited to the UK for very long, but in time I believe we'll be speaking about many billions a year in earnings on GBM alone, if tumor agnostic label comes in, move the decimal point a couple to the right. Triple and quadruple digit share prices would become possible, if NWBO hasn't been bought out before then.
This won't happen in 2024, or 2025, but perhaps by 2026 we're starting to see the sort of earnings that validate triple digit prices, if that turns out to be the case, it won't stop there. By 2026 it's very possible that we'll be looking at DCVax-Direct approaching approvals as well, that will take care of those with inoperable tumors who can't get DCVax-L. I would suspect that well before this happens we'll have at least on BP partner, and the money that partner pays NWBO will cover much of the expansion and trial costs NWBO must support to grow, which truly will turn most DCVax-L sales into true earnings. Who knows, we might be 3 billion shares outstanding by then, so at a P/E of 30 each billion would represent $10 in share price, but we'll be at or very near double digit billions in earnings by then.
Gary
Meirluc, to the best of my knowledge, the approval of an FDA BLA or NDA includes the approval of the commercial production facility that will be employed for the product. In the UK, this facility is approved prior to the submission of the MAA.
If NWBO submitted a plan that showed sufficient capacity to meet demands with manual production, as they did with Provenge, I believe that they could gain approval. I don't believe that it's the direction the company wants to go, but if it's impossible to gain approval to utilize the EDEN unit in a reasonable amount of time, the manual option is not out of the question.
As I've said previously, the inspection and approval of the production facility can come toward the end of the 6 month period established by the PDUFA, so if the company was certain they'd gain approval of the EDEN in a matter of a few months, they could submit their BLA prior to EDEN approval. The entire facility should be ready for inspection by at least a couple months before the PDUFA date to permit some minor corrections and reinspection prior to the PDUFA date. While it would be better to know the EDEN was approved going it, it would be up to the company if they wished to take some risk with an earlier submission.
It's my belief that if EDEN never existed, DCVax-L would be approved and a massive number of cleanrooms would be built for manual production of it. It would be far costlier to produce, employ substantially more highly paid people, require far more construction, but it could be done, and demand for it would be as great, as long as insurance paid for it. It would be profitable, and it certainly will be in the UK with manual production, though I suspect the earnings for each batch will be lower when produced manually than if produced in the EDEN or other similar device.
Gary
I hate admitting you're right, but many had felt as I had. My belief in NWBO's potential is in no way diminished, and if a BP partnership takes place this year a much higher price is possible, but the lower figures anticipate a slower pace in adopting DCVax-L and the EDEN. If when we learn the company's intent on all regulators and commercial production, and by the end of this year it could all happen, then much more is possible this year, including a BP partnership at the $20+ a share price LP has previously said she wanted.
Gary
I agree Dstock, but I'm not certain if I wouldn't have said the same thing a year ago. I still believe that the EDEN unit is the key to so many things moving forward, hopefully it's getting very close to becoming available for commercial production. Hopefully this and many other things will become clear when they hold an Annual Meeting.
If I'm not mistaken, after holding the Annual Meeting for 2023, hopefully soon, the company should rightfully hold a meeting for this year later this year, I don't believe they can say one meeting intended for last year covers both because it happened in 2024. I actually believe that Annual Meetings are supposed to be scheduled near mid year, people were pushing the company to do so in 2022 and they finally did it the last business day of the year. While Investors can force meetings if they wish to sue, on the OTC when things are supposed to be done doesn't really seem to matter. Things may be different when they get on a major exchange.
Gary
JT, I hate to even mention it, but I believe hundreds of millions of options exist, probably at an average of $.30 to $.40. If the company wished, I believe they could say that all options must be converted in a matter of months. While these are very cheap shares, in reality it could bring in something in excess of $100 million I believe. That would resolve the immediate problem.
Don't get me wrong, the intent might be to just maintain the options until the company is eventually bought out, but eventually the holders of these options will be very well paid. Over at IMGN, with their recently announced buyout, incentive shares awarded to all sorts of their staff are coming out of the woodwork as all are eligible to cash out their shares before the buyout. A lot of multi-millionaires are coming out of the buyout. Much the same will probably happen here in a few years.
Gary
Dstock,
You may be right, but I really don't think the expansion at BP's is specifically for NWBO, though it's possible that part of it could play into either partnership or buyout. I still believe the CRL facility in Memphis will play a big part once we have approvals outside the UK and EU. I don't doubt that one or more BP's have spoken with LP, but I don't believe anything is so firm that they're investing in production facilities purely for DCVax-L. There is no doubt that biologics will play a bigger part of the entire industry, and I do expect that over time more truly personalized products will be developed, but BP's will go screaming and kicking into that world, they still want to market mass produced products.
I certainly could be wrong, for all I know all that needs to happen is certain key events and a BP has already agreed to all the terms of a partnership or buyout at prices that are already established. While I don't think so, anything is possible. If I'm wrong, the key event might be as little as UK approval, to as much as certification of the EDEN unit and approval of all four regulators, or even more. It's also possible that it's keyed to a specific stock price, regardless of how it's achieved. Generally companies don't pay more than double the current share price, but occasionally they'll pay more than that, but you won't see $20 a share for a $2 stock, maybe $7, but that would be a stretch IMHO unless it came with news that would have driven the stock to $10 or more without the partnership or buyout.
Right now the key is gaining UK approval, after that I think a lot of things will start to fall into place. Things will be happening while we're waiting for the UK action, but it will be the first really big news IMHO.
Gary
Doc,
I agree with you completely, but that's also the way I felt about IMGN, and the management went and sold it anyway, unless investors turn them down. NWBO with a tumor agnostic label for DCVax-L, worldwide approvals for it, and Direct approaching approval could be worth more than any one BP could afford, so if we're to be bought, it will probably happen before then. I would not be surprised to see a high double digit or low triple digit billion buyout price if DCVax-L has been approved by all four regulators and demonstrated to be tumor agnostic, even if not fully approved for it. I honestly doubt it will go that far, if it is to be bought out.
Let's see what the company has to say about when they intend to go to the other three regulators, if we're to be bought out, I suspect it could happen before all four regulators have approved and it might well come about the time they file with the FDA, or before the PDUFA date established by them.
I still rather like the idea of NWBO remaining independent, but believe that if a buyout comes in at $30 billion or more, LP will probably take it if it comes before FDA approval. After FDA approval I think the price goes up dramatically. A PDUFA date this year would require filing by June, at the latest, not impossible, but lets see what we're told when they have the Annual Meeting.
Gary
That's not true, the EU and European versions of Clinical Trials had already been changed, the regulators were all working together, so it was accepted, but it wasn't properly documented in the US, that came a few days later. I can't say if the company's submission was delayed, or if the NIH, who I understand posts such changes took exceptionally long in doing so, but it's clear the regulators had accepted the changes to the trial back when the trial resumed after the halt.
To me, the presentation should have been clearer about it, and it's clear that Dr. Liau had prepared the visuals, even though she didn't present it. We'll never know if she would have discussed it differently when she showed the slides as she never had the opportunity.
I remember the company being surprise when the clinical trial sites in Europe were updated. I have no idea why they waited on submitting in the US themselves, I doubt that we'll ever hear what their reasoning was, but clearly it hurt at the time of the presentation.
Over the years I've seen many things that IMGN shareholders questioned that were similar to what NWBO had done, it happens. NWBO is really a very small company, if you have a dozen task and prioritize them, the lowest may simply not get done in a timely way, even though it's just a matter of documenting something that all have agreed with. If you look at the Clinical Trial database you'll find all sorts of trials by many companies that should have been updated, that haven't been updated in spite of trials ending, or trials being well beyond when they were intended to end, but simply not modified to show their current status. Sadly it should have happened before the presentation, but it wasn't.
Gary
While $5 a share sounds reasonable, when you consider the shares outstanding, it would represent about a $7 billion market cap. That's probably a little high prior to the approval of our vaccine. Based on the potential of our vaccine a $1 to $2 billion market cap would seem to be justified, but $7 billion is probably a little high at this time.
Once we gain approval it's a different matter, but lets see the other news that we should get when the company does hold its Annual Meeting. I believe our market cap will substantially be influenced by how quickly we'll be filing with the other regulators as well as how quickly commercial production utilizing the EDEN unit is available. If it's anticipated that all these things should be happening this year, I'd suspect a $5 to $10 share price is very possible this year. If by chance we also partner with BP's, etc. in drug trials, or otherwise, the terms of those agreements may also boost the share price dramatically higher.
If you look at other companies that are in similar situations to us, I think you'll find that most are under $1 billion in market cap. Approval makes a huge difference, especially if revenue growth is dramatically higher quarter after quarter. A company that is potentially offering the ability to benefit most every solid cancer should be huge, but that potential has to be proven to be a reality. If NWBO isn't acquired, and if its vaccines become a part of the SOC for most solid cancers, a trillion dollar market cap is not out of the long term possibilities, but it will take many years, perhaps a decade or more to move from where we are to when our DCVax's are being utilized worldwide in the treatment of many solid cancers.
Many believe the BP's will never let this happen, once the DCVax's, perhaps just L, is proven, they'll make an offer that we simply can't refuse. While I'd love to see what the company was by say 2030, if left to grow on it's own, I suspect that it could possibly be acquired well before that, perhaps as early as later this year.
Gary
It seems to me that AdamF began the put down of NWBO on the 9th with the announcement that Dr. Liau wasn't going to make the presentation, and essentially was ducking it by claiming to have Covid in England. He got the snowball rolling downhill and just kept it going with allegations that the trial failed on the basis of PFS
If there is one thing that can be said about AdamF, he has good sources everywhere. Had the company heard from Dr. Liau and issued a PR saying that she'd not be making the presentation, then building up the capabilities of the presenter substituting for her, AdamF's impact would have been nil, but we didn't hear it from the company, we heard it from AdamF along with all his other allegations of failure and that Dr. Liau wasn't sick at all, just ducking the presentation because of the failure. Adam is certainly a tool of the shorts, whether he was also working with the spoofing MM's that day may not be provable, if the record didn't show it clearly, it wasn't used. Perhaps the attorney's have other plans for AdamF, or simply embarrass him by showing how wrong he can be.
Monday is a holiday here, but I don't believe that's the case in the UK. Perhaps news will come in by then, and we'll be greeted by it when the market opens on Tuesday. Happy MLK Day everyone.
Gary
Mike,
As I understand the capabilities of the new solar cells in development, even on the shady side of a roof they would generate substantial power. What I really believe would be huge for areas that get snow in the Winter would be solar shingles that incorporated the ability to heat sufficiently to melt the snow and keep the roof generating right through the Winter. I've spoken to people who are certain it's possible, but no one is doing it to our knowledge.
I believe that Musk already makes decorative solar shingles, rather than putting solar panels on the roof. New construction should always use these, but of course the cost would be greater. I suspect that if mandated, price would come down and roofs could be engineered to look as good as any of today's roofs.
Gary
The question that I think should be asked of Drs. that have their own vaccines is whether they violate the patents NWBO already has in place. I don't know that this is the case, but I think it could be. I don't believe that you enforce the patent rights until such time as the vaccine has been approved in the country the Dr. is working in.
Gary
I would hope that by next week we are notified of acceptance of the MAA by the UK authorities. If not, I'm wondering if they've actually come back to NWBO and suggested changes that have to be made before an acceptance is possible. I certainly have no expertise in this area, so I'd like the opinion of those who do.
My previous experience generally didn't have companies saying they submitted, generally they'd provide guidance as to roughly what quarter they intended to submit, but not that they actually did it. They would announce that a submission was accepted.
I can't tell you with IMGN how many times an investor found something in clinical trials and those who followed a number of chat sites knew all about it before the company ever put out a PR. I can't say that they waited for investors to find out what they'd done, but clearly they didn't put it out as early as they could have. Much the same can be said of presentations at major conferences, like ASCO. Investors searching the conference website found presentations that to date were unannounced by the company. I frankly have no idea why companies operate in this manner, but IMGN is far from the only one that does, it's just the one I have the most experience with.
I hate to say it, but I suspect that NWBO would have been better served if the only announcement they made about filing an MAA had simply said that we intend to do it in the fourth quarter. I suspect that they could have said that as early as the second quarter, and perhaps reiterated in on many other occasions, and whether they did it in October or not until the end of December the statement would have been correct.
It's also my opinion that in the 1.7 million pages they've provided evidence that could support a tumor agnostic label. I'm not suggesting the filing is all or nothing, if a GBM or brain cancer label is issued, they'll be satisfied, but I believe that they've provided sufficient evidence to get a tumor agnostic label, with a confirming trial required to make it permanent, if the regulator chooses to make such a stretch. I have zero expertise, so this is purely IMHO.
I suspect that if many investors believe next week will be when we get acceptance from the UK, FOMO should send the share price higher before the close.
Gary
Dmb,
What you say is true, but I believe that with both incentives, and improvements in what's available in both solar, and manufacturing, the dramatically lower cost of labor in places like China won't matter nearly as much, and in fact a better trained and higher skilled workforce in the US, etc. may actually be able to deliver at lower costs. Of course this would involve far fewer workers, as plants would be far more automated, but that's possible today, but wouldn't have been 50, 25 or perhaps even 10 years ago when decisions were made to move all this production offshore.
I hate to say it, but Musk once again is pushing things in the right direction. He's developed new solar panels that can be used far more flexibly, produce more power, even on darker days, etc. I'm sure he's not the only one. Year's ago I met a former Asst. Governor of California who was involved with a solar company. He swore that he could coat the sails of my boat and generate power right from the sails, and they still could be furled normally without harming the coating. In general he was saying that buildings, etc. could have this material sprayed on and become solar collectors. I don't know if they actually achieved what he said he could do, but believe that some day, something like that will happen. Today, however, I suspect that buildings could be made with new materials that made most surfaces collectors, and if it were mandated, the costs could come down to only slightly higher than current prices. The buildings should actually require less maintenance, as color and texture would be built into the materials, and they would never be painted over, etc. Glass can become solar collectors without seeing anything within it, Musk and others are able to do that. No doubt, it adds cost, but if it were mandated, so it must be used, I believe the costs would drop to just slightly more than the current cost of glass.
Without such mandates, most builders will choose to build with cheaper equipment, and sell at lower prices, even though many homes go into the millions of dollars. Incentives and mandates are needed to make us do what's best for the planet, and mankind long term. A friend is working with some of the worlds wealthiest people in a multi-trillion dollar effort on climate improvement that's completely independent of the worlds govts. These people realize that dramatic change is needed if we're to keep the planet viable for human life, but while if I'm very lucky I may be here another 20 years, I won't see the really big changes, but I believe my daughters will. I believe that sea level rise will either flood much of the lowest lying lands, or require massive sea walls to be built in many coastal areas. Weather changes are clearly happening, and they'll happen faster. I changed to a heat pump that's far more efficient for heating and cooling, and my solar system handles it, and I believe it will continue to do so with the weather changes we'll face.
My boat is in Marina del Rey, I have little doubt that sea walls will need to be raised in 20 years, or less, and the floating docks adapted to not come off the pilings by either changing all the pilings to go higher, or adapting the dock to stay on the piling in spite of floating a few feet above it during extreme high tides. A massive job either way. The recent storms and waves that hit California brought water several feet high into homes and hotels, etc. that have never been hit with sea water before, it will only get worse in years to come.
I don't want to sound fatalistic, I believe we can deal with all of this, but it will take an effort and solar is a big part of it, as is reducing all dumping of all sort pollutants worldwide. Fusion will be another big help, but the biggest thing is just not treating our planet as if we can dump anything we wish into it. I don't know how many species have died off largely because of man, but we need to do something before we become one of them. Our politicians fighting, rather than agreeing on a course of action is a strong indication of what's wrong in the world. There will always be a need for some petroleum, but the less of it we need, the healthier our planet will become.
Who knows, perhaps 100 years from now the work week will be down to 20 hours and we'll all have plenty of leisure time and money because of the changes we're making, we'll be healthier and wealthier, but only if we agree to make the right changes near term to make it happen. Who knows, by then NWBO may be bigger than any of the BP's today.
Gary
Laguna was the first place I ever skin dived, I happened to get a day when the water was crystal clear, it was magic. But Avalon, CA, is one of my favorite places, but you can only drive there by boat, if you're driving. Sitting on a boat in the harbor you get a feeling that it's like being in many delightful foreign ports, yet as the song says, it's just 26 miles across the sea on Catalina Island.
It's not the same being in a hotel there, but it's still a great place to spend a few days, numerous restaurants, tours, tourist stores, etc. and the only place I know where steps lead down to an underwater preserve that offers clear, but generally cold water, and skin or scuba diving that's enjoyable and scenic at any depth. I don't know that we all should meet there, but if you're in Southern California it's certainly worth seeing. When I say the water's cold, it's far warmer than Tahoe, mid 70's in a warm Summer, a wet suit would be nice, but I've spent hours there over the years in only swim trunks.
I still like Tahoe for a rendezvous, the beauty of the mountains and lake, casino's, and Vegas styled shows in Reno for a fraction of price. I haven't skied since getting the leukemia year's ago, so Summer's are when I prefer it, but it's beautiful in the snow and skiing is great in the Winter.
I think such a rendezvous ought to be something planned once NWBO is on a major exchange, at that time the cost should be pocket change to nearly all longs here.
Gary
I agree completely about the importance of the EDEN, but don't think it should slow or accelerate the effort. I'm frankly unsure if the company will approach the FDA, and perhaps other regulators without the EDEN, but clearly the UK approval can come without it.
I don't believe that the EDEN must be approved prior to applying for approval, but with a PDUDA date set 6 months after filing, the approval of the EDEN by 5 months after applying would permit inspection of the production facility prior to the PDUFA date.
I believe the importance of the Annual Meeting is giving investors an update on the progress being made on all of this, certainly the EDEN's a key unless the company announces that it's intending to go for approval with manual production capability, and the EDEN will follow later. Let's hope we get UK acceptance and the scheduling of the AM shortly.
Gary
The two means of production should be a separate issue, at least for the UK where manual production has already been approved for commercial use.
Gary
That may be the case, but in terms of an Annual Meeting the company was supposed to have it in July 2022 and waited till the end of December. My feeling is that they want to be in a position to announcte certain thinbgs, so I think it's better to let them have it their way, but if investors want to go to court it can be forced after 13 months.
They clearly know that we are anxious, but I think we should let them choose when they are ready to speak to us.
Gary
I believe that what's said at the AM may make a difference, but it depends on what's actually said. If multiple approvals are anticipated this year, that would be a big positive, likewise approval of the EDEN unit. On the other hand, if no such guidance is given, if submission to the UK is all that's planned for the year, it will take UK approval to to really move the stock. I expect we'll be somewhere between the best and worst we anticipate will happen this year.
I would hope that any AM will be done as in recent years, people wishing to can attend live, others can participate by webcast in the formal meeting. The advantage of attending is the ability to speak with key people one on one outside of the official meeting, that's an opportunity that can't possibly be done by webcast. We'll probably be asked to send questions, but they won't be answered as questions, rather they'll be consolidated and answered by a statement from LP intended to cover them. Investors won't be completely satisfied, but we'll know much more than we know today.
Gary
Smitty,
Cramer won't speak with companies trading as low as NWBO, I don't think he'll speak about OTC's at all unless they're uplisting already. But I believe that if we got a major story on a national network we'd get a spike up, and yes it would fall, but not to anywhere near what we're currently trading for.
Dr. Liau now has a position with the company, so she ought to be able to openly speak for the company, not just the work being done at UCLA, but I'm not certain that she'd do it. LP is really the one who should be speaking at investors conferences, like the JP Morgan Healthcare Conference this week. In the few years that I've been an investor in NWBO, I can't think of any investors conference she's spoken at. Actually very few of them will probably invite the CEO of a penny stock, but some certainly will, and organizations like BIO routinely have conferences where participants pay to present, it may be worth their money to occasionally make such presentation to bolster the share price.
Of course all this will change with approvals and dramatically higher share prices, we just need to live through the time necessary to make that happen. Year's ago a NY Times article on Judah Folkman took a company, I think it was ENMD, from a dollar to over a hundred on curing mice, but they said if given 2 years he'd cure cancer. It fell almost as quickly as it arose, but now it's gone the other way, sometimes stocks fall on drug approvals until sufficient revenue is seen from sales for them to rise. Unless we go into approval at much, much higher share prices I don't think that will be the case with us. Shorts have cast so much doubt about approvals that I believe we'll fly when it happens, if we don't somehow fly before.
If Cramer ever mentions NWBO it will be because we're already a big success from where we are today. If he hasn't changed his rules, he won't discuss anything under $4, roughly seven times our current price. It very well may happen later this year, but when it does, we won't care that much about it. When we're $4 or more Institutional investment will increase dramatically, by $5 to $7 I wouldn't be surprised if 50% or more of our stock will be owned by Institutions. At that point the MM's won't be controlling the share price, the Institutions will have a big say.
Gary
Flipper,
I think DI has learned from last year's Annual Meeting. On more than one occasion he opined that it would happen in a month or so, but it didn't. I think the company had reason for waiting, but I believe he learned that until they set a date and announce it, he won't give guidance that's easily superseded. As the IR person I tend to believe he's kept out of the loop until decisions are made to avoid him giving wrongful guidance.
Last week I felt like if they had UK acceptance late in the week they should hold till Monday, as we drift lower I'm changing my mind, we need some good news, they shouldn't hold it at all. If they do intend to announce the Annual Meeting shortly after gaining acceptance of the MAA, that they could hold until the following Monday. I view the Annual Meeting as a positive event as it's the one time management gives us a hint of what's happening. I'd certainly like it more frequently, like in webcasts with each quarterly, perhaps some day that will happen. I don't know that it's mandated if we were on a major exchange, but companies I follow that are on them do it every quarter.
Gary