Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
My belief about what happens on approval is largely based on how the news is accepted by the media. If a PR is all that's seen from the company, no webcast, no coverage by major media, then trading in the $1 to $3 range is about all that can be anticipated.
On the other hand, if media coverage is tremendous, if major networks and newspapers cover the story, then anything is possible.
I expect that we'll be somewhere between the extremes, perhaps see a high for the day in the $5 area. If I'm right, it will be a month or less when we know.
Gary
Sorry, somehow hit the wrong label.
Just a comment on some of the last 70 posts, I agree with the poster who indicates the market doesn't believe in an approval in the near term. However I'd add to that that over 99% of investors have never heard of NWBO. What do you think will happen on approval if just 5 to 10% of the market hears of DCVax-L's approval? How high might UP be?
I'd also note that NWBO is on the OTC, it's not a Pink, there is a difference.
I also agree the MM's create a naked short by moving shares from one to another and they can do it almost infinitely. When they go further short by selling these shares to a legitimate buyer, they do have to make the buyer whole. The broker the buyer purchased through doesn't know the shares were naked in the first place, so if the buyer lends shares to gain interest, or the brokerage has the right to sell his shares because he has a margin position in the account, those naked shares could very well create additional naked shares. I really question if anyone really knows how many shares are naked until the stock makes a major move up, margin calls hit, and those naked must close out their positions. I suppose even then the MM's can keep a fair number floating between them, that's the business they're in.
As the price moves up, and the MM's Institutional customers want to purchase major positions, they'll want to accumulate shares to meet their demand, but also may go short to keep their Institutional customers happy. When a company moves onto a Russell index, etc. the MM's often accumulate millions of shares and all Institutional shares are acquired after hours on the day the Russell changes are made. A substantial short position often occurs at this point as well. In one case I saw a large short position maintained for two years until the company was removed from the Russell index, the MM's can play games like that.
When the Institutions want to establish a big position the MM's will also approach the company encouraging them to do an offering that's fully subscribed by the time it's announced, the instant infusion of cash is often something they won't turn down while putting shares into Institutional hands, where they like to have them. Much of the growth in Institutional ownership will come from such offerings.
Gary
Griffin can't be wrong all the time. I don't know if he's ever said the same about LP, even if he's bet against her. Nunez is a Trump lackey who's only being rewarded for his loyalty, not his skills. I believe DJT will be down to single digits by Winter unless they find a legitimate way of developing a revenue stream.
Gary
Once you get to revenue in the billions, does it really matter that much precisely how many. The company that is benefitting those with the diseases we could should be worthy of a P/E in the 20 to 30 range. Just a few billion puts our market cap at triple digit billions.
Gary
I'm only a few weeks since back surgery so I'm restricted from doing anything except walking, but even a couple blocks of that really tires me out. I may have a thyroid issue, which my Dr. says can be easily handled with a drug, but he's not yet added the drug to the myriad of meds I take for blood pressure, GERD's, etc. Getting old isn't for the timid. I hardly go a week without an appt. with one of my Drs.
I've never minded driving myself, and probably will get an electric with hands free capability in the right places, but if NWBO hits as big as it may, perhaps using a limo service could be a nice luxury to employ on occasions. We used to travel to Tahoe many times a year, I have a place up there, if I get back in shape I plan to do it again, and I'll hope that self driving capability will work on sections of 395 as it's a much nicer ride than taking 5 to 80, but I'm practically certain it would offer self driving nearly all the way. I'll wait for the 2025 models as nearly all will get the Tesla plug and be eligible to use their charging network. When home I intend the car to act as my battery pack in running the house during power outages linked to the solar I've already installed.
I really believe that a month from today, or sooner, we'll all be in much better financial shape, at least all of us longs, the shorts will be licking their wounds.
Gary
They should be providing first quarter earnings during the first week of May, anyone think that will include anything from Core Optics or be prepared by their people?
Gary
I know the submission that NWBO made to the UK was 1.7 million pages and their production facility was approved prior to the submission. I'm not saying the same would be true here, but the regulators do seem to take an ungodly amount of paperwork if you don't want questions, and further delays because you've covered all the bases. If they were submitting a BLA to the FDA it would have to include information on commercial production and I expect most of what's in the UK submission would be included, so it would probably be larger.
I would suspect that many of the 1.7 million pages will never see the light of day, but if there are questions on key pages the answers can be found somewhere inside those pages.
Gary
Doc, as I see it the Pinks and OTC is the Wild West of the stock market, they're subject to little interference from the regulators. If Posner paints such a clear picture that the authorities can't ignore it, the SEC may investigate it further. I suspect that if they settle, that will end everything and no one will be looking further into what happened.
I suspect it would have been different if NWBO was selling for more, and had been on a major exchange when the spoofing was alleged, but that wasn't the case unless Posner brought in proof that predated the company coming off the Nasdaq.
I suspect that this will settle as more than what the court awards could be at risk to the MM's if it goes to trial.
Gary
My Dr. wants me to hydrate much more too, he indicated any liquid counts, except alcoholic, which dehydrates. Year ago people said that drinks with caffeine, etc didn't hydrate, but sanity has prevailed.
Likewise, in hospitals the guidance used to be cook everything extra well done. Now guidance has changed, they've recognized that things can be moist, meats on the rarer side, etc. I don't know if the cooks have changed their way of doing things, but I've seen the guidance and they could cook far better tasting food if they're following the new guidance. Fortunately I haven't been in the hospital much after they received that guidance, so I really don't know.
I've not been much of a drinker since becoming a senior, but on occasion I love a good drink, I don't believe it to be that harmful, just not hydrating.
Gary
I for one never put in market orders, but frankly I almost never buy less than 1000 shares, and often 10,000 or more. If the bid is $.4878 and the ask is $.4883 I'll either put my limit at $.489 or just $.49. Most of the time I find that I've bought the shares for something slightly under the $.4883, but do I really care that much. It's $4883 for 10K shares at the lower price, or $4900 at my higher offer, a $17 difference, that's pocket change, I frankly wish that we weren't even trading at tenths of a penny, yet alone hundredths. When a 1/32 of a dollar was about the smallest spread between bid and ask, and most spreads were 1/8th or 1/4, we didn't have the sort of trading we have today with computers, and I suspect that if the rules were changed, computers would still be used for trading, but not nearly as much churn. It's rare that my orders don't fill in bidding this way, but if a stock is rapidly moving up I may ultimately raise my bid. A market order gives the MM's a chance to play, if in the above example they get $.53 for the shares you bought, that's a $400 difference, more than pocket change.
We've all seen the MM's drop the price $.02 or more on the last order of the day, under the right circumstances they can do the same thing on buying, or selling with a market order any time during the day. I don't attempt to watch all the trading, but even if you do, at times you hardly see a new high, or low for the day as MM's play games with a single market order than immediately back to where trading was previously. As the stock price goes higher they can play games at much higher values.
Computers can make money with many trades with tiny spreads, I won't say people can't, but computers are at a huge advantage. We really don't need the tiny spreads, a step backwards would be a step in the right direction.
Gary
I frankly don't remember who, nor do I know the source, but a very knowledgeable investor, who I believe lives in Europe, posted that no information had been requested from the company. I believe that was the case, but of course it's possible that it isn't. I suspect that in a 1.7 million page filing that is believed to have been in a rolling review, all the UK wanted was handled in the discussions or can be found in the submission somewhere. I'd hate to be the one that needed to find it, though I suspect a search routine will find nearly anything within all those 1.7 million pages.
I don't believe that the company would tell us if there was a delay because of information requested, just as they didn't tell us of formal acceptance of their submission. I would guess this would also be true of nearly all the other biotech's, so lets not make a big thing out of what the company does, or doesn't say. They will tell us if the UK approves, or if not and the reason why. I still believe the likelihood is in the 90% range, but I'll never be able to explain some of the delays caused in the past by our FDA, but I've seen blockbuster drugs that had tremendous benefits delayed by years by the FDA. I believe the FDA has improved in recent years, but no matter how good a drug is, you can never be 100% certain of approval.
I certainly have no personal knowledge of anyone making the decision in the UK, nor have I attempted to gain what should be proprietary information from the company, but I do believe that there are people here who may have such contacts. As I indicated earlier, I suspect that some of the BP's, with their industrial spies, may know the regulatory outcome before NWBO does.
Gary
Dstock, I agree with you completely that any BP that even dabbles in Oncology is paying attention to NWBO. Essentially I believe most of these BP's have an opinion of what their products will do if combined in treatment with DCVax-L or Direct. Some, like Merck, certainly believe that there are synergies where the approval of the DCVax's will actually enhance their sales. Others will see their products as totally threatened by the DCVax's.
Partnerships to run trials combining DCVax-L with other BP products are almost certain, the BP may pay substantially for the trial. I really don't believe that LP would sell a substantial stock position to any BP at much under $20, but such buy-ins could be part of such agreements at strike prices that probably wouldn't be fully disclosed.
Most biotech's have previously said they didn't want to reveal information they could because it would be of advantage to their competition. From what I've gathered most BP's have sources practically everywhere and often know more about what's happening in a trial than the trial sponsor because the sponsor is restricted from knowing what's happening, while the BP has spies.
An approval in the UK should open the door to many things starting to happen, some of them LP will discuss, others will be happening under the radar until they reach the point they'll be announced. If LP is intending to take on equity partners in the foreseeable future, I believe she'll use that as a reason to once again raise the authorized shares when they hold the next Annual Meeting. If she doesn't bring it up, it's alway possible to have a special meeting to both accept such a partnership and authorize the additional shares if that is desired later.
As I see it, allowing roughly 30 days for an Annual Meeting once it's announced, we'd be looking at late May, and more likely June at the earliest. I really don't know if they'll call it the 2024 Meeting, or the 2023, or perhaps the 2023-2024 Meeting, but I really don't believe we'll have two Annual Meetings within this calendar year. Of course if LP has a reason she wants a second meeting this year, we'd have it.
To me, one of the biggest achievements the company should make this year is a listing on the Nasdaq or NYSE. I don't believe it can happen instantly on reaching the required share price, but a matter of months later as long as the share price is sustained. It's possible that after approval is announced the Nasdaq will want us back and agree to relist us at below the $4 required for a new listing because we were previously listed there before. I say that, but I've gathered that LP really wants us on the NYSE so I really have no idea if she'd go after a Nasdaq listing sooner. The big change that happens once we're on a major exchange is greater Institutional investment. Some Institutions can invest on meeting their minimum price, but many also require being on a major exchange. By the end of this year I believe we'll be on a major exchange and probably at least 25% Institutionally owned. If NWBO is as successful as I believe it will be, it won't be that long before Institutions will have majority ownership and if it's not bought out, at some point they may have 80 to 90% of the company. Individual investors will make the greatest percentage gains, but Institutions will make the greatest dollar gains.
Gary
I've not spoken with Dave I recently, however others who have make it sound like with approval we'll start to get a stream of positive news, not simply an announcement that we have UK approval. While I feel relatively certain that one thing will be the announcement of an Annual Meeting, perhaps about a month later, but I don't think they'll wait for that to announce other positive developments.
Today, I'd be surprised if 1% of the investment public has heard of, or paid serious attention to NWBO. By the time they have the Annual Meeting, I believe the majority of the investment public will have heard of the company. Of course all won't be investors, that never happens, many wouldn't consider it under any circumstances, biotech's just aren't their thing, or they only invest in blue chip companies, indexes, mutual funds, etc. Of many of the people I know, they wouldn't consider the company till it's trading for at least $5, and many would want far more than that. By that time I'll have a ten banger, or very close to it, and a portfolio worth a couple million. To some people any stock below $5 is a penny stock, regardless of what exchange it's on. I always find it amazing that some people look at a stock that's moved from $100 to $150 in a year as a great investment, but won't be excited about a company that moves from under $.50 to $2.00, and I believe we could do far better than that this year.
Tesla is selling at 52 week lows, many would need it to double, or better, just to be break-even on the year, yet I'd bet that many still believe it's a fine investment. It's a mindset about what's good, and what's not, Tesla's been a $400 stock before, and people feel it will be it again. That's tremendous success in their minds, but under three times what it is today. At $1.50 we'd have a larger percentage gain, and that could easily happen within minutes, or less, of the price we should have with an approval announcement. If the stock is halted on the news, it may very well open above $1.50 or even $2 and in that it represents under a $3 billion market cap it would be reasonable for a stock that represents the potential that NWBO does. The more people learn about NWBO the more a double digit billion dollar market cap will be justified.
Gary
John, as I think you can tell, I'm not an expert on the technology here, nor do I attempt to be. I've liked what I've seen they're doing, and am willing to sit back and watch them come to fruition. If the price continues downward, when I sense a bottom I'll very probably buy more. If good news comes in and the price is up substantially, I'll think about buying when it retrenches some of the gain.
In terms of the big gains I anticipate from the stock, really only approvals can achieve that. Don't get me wrong, a Journal article, presentation, or other positive trial news can achieve a nice, sustained gain, but for prices well in double digits I believe at least one approval is needed, perhaps more, and of course approval leads to revenue.
Missling got some of his experience at IMGN, I hope he doesn't follow their lead and sell the company too early after initial success. Personally I'd prefer companies possible partnering with BP's than being bought by them, but reality seems to be, if the company has something worthwhile, the BP will want it all and with all the key people having substantial stock and options, instant tremendous wealth is a strong incentive to management selling out.
Gary
Yesterday afternoon, at 12:30 to be more precise, we have a standing Rummy-Q game at the club. I've been telling some of the players about NWBO for many months, but this time I mentioned my belief that on Monday I thought that there is about a 10% chance we'll get UK approval. By 1:00 when the market closed two of the players bought stock, but not near the low that occurred at the close.
Technicians would almost certainly say that the close would indicate that nothing good is anticipated on Monday, they believe that something always indicates something is coming, and nothing that we've done in even the past few weeks says so, but I'll still maintain a 10% chance, which is still saying 90% that nothing happens. By May 22nd I'd say that there is a 90% chance that something will have happened, but of course when it comes to regulators, you can never be 100% sure of their actions.
Fear of loss is an important component of investing, my daughters and I had also invested more that morning when I told my daughters of my thought about the 10% possibility, they had money available in their accounts which I had access to and both told me to get more. I added just enough in my account to bring our total to a nice, even figure. It's clear that at the close fear of loss didn't apply, and perhaps it won't on any day prior to approval being announced. The MM's and shorts are doing a masterful job of controlling the price, and I suspect that many are working their way out of short positions, but their time is clearly limited.
If news doesn't hit on Monday, I'd still estimate 10% chance for the remainder of the week. By the following week it ought to be up to 25%, and 50% the next. Beyond that we're closing in on May 22nd and 75% to 90% ought to apply as we move toward the 150th day. Of course the company has a couple days to release the news, so if it comes late in the week they may hold it strategically to Monday.
Gary
Companies generally won't discuss data before it's been presented under peer review in some venue. I have no idea which journal they're looking to be published in, but even they may have restrictions on what the company can say until they publish. In NWBO's case, the Journal was taking so long that they filed an Abstract at NYAS and Dr. Liau was supposed to make the presentation. She got Covid in England and AdamF openly said she was faking and called it a failure that she didn't want to present. It worked for the shorts, instead of moving up, as it had prior to the conference, it tanked on someone else presenting who couldn't really explain the trial that well. The Journal was issued some time later, but sadly the allegations of failure remain and can only be eliminated with an approval, which the UK should do in the next 30 days.
The same thing may apply here. If the company doesn't violate terms of presenting in the Journal they could probably submit an Abstract to an upcoming appropriate conference and make a peer reviewed presentation. Once made, the company would be free to discuss what was presented. Until either Journal or peer reviewed presentation companies don't discuss such data. I've seen little discussions about the people who've been running the trials. I believe that it's normal for the lead clinician to also take the lead in creating either an Abstract or Journal, and many of the other clinicians participate along with key scientific people from the company. The company can certainly package all the data and submit it to the regulators before it's been peer reviews, but frankly I like the idea that the regulators have a preview from a Journal or peer reviewed presentation at a major conference. Let's hope we get the Journal shortly, some discussion of what's in it, and the submission to at least one regulator.
Gary
BC, you're right about my lack of knowledge, but Missling's specialty if finance in biotech, he's not a scientist developing new drugs, how can he be telling the scientists how to do their jobs. With four years of funds I've got to guess he's doing that side of the business fairly well, but developing new drugs and designing trials to test them is something requiring a different type of expertise. Others have said he's hired people well qualified to build the regulatory documents properly, if that's truly the case he needs to step back and let them do their jobs.
I believe that what you're saying about Missling is probably true for many CEO's, whether it's in biotech, or elsewhere. In general they're optimists and believe almost everything can be done faster than it is, and if they're called on to do something themselves they find out why. It seems like every job looks easier to the person who doesn't have to do it.
Nearly 4 decades ago IMGN's CEO was named Mitch Sayare. Mitch would often speak to investors, and even got in trouble with the SEC for posting on Silicon Investor, but when he said something would happen, it eventually did. Thing was, he often said it would be happening soon. In some cases soon turned out to be well over a year and posters discussing it all just spelled it backwards as NOOS. I did like Mitch, met him a couple times and spoke with him on the phone. Had he remained with the company I very much doubt that he would have sold the company at the price they obtained by rushing into a sale before sales revenue could build for their newly approved drug.
I think with approval it's possible that Anavex could become a buyout target. I would hope that they don't act to quickly and while profitable for all sell out too soon. I believe approvals of their products have the potential of earning billions annually, a market cap in the mid to high double or even low triple digit billions is very possible.
Gary
I still feel confident in my shares at Fidelity and have again added to my daughter's and my position to take it to a nice round figure for all of us. I believe that Fidelity will be able to deal with all share issues and no shares will be lost. In each of three trades I made today I put in limits at $.50 and in every case the trades were slightly below that price.
Gary
John,
I don't know what can, or can't be included in a regulatory filing, but if it's possible to add the continued use of the drug and testimony of the observers that the patients were more stable than before they began the trial. As I understand the drug, it doesn't necessarily cure the disease completely, but it improves the condition which is very detectable. Sadly in the placebo group the desire for seeing improvement may have lead to a view that some improvement was being seen, that opinion doesn't remain forever, but apparently did for the duration of the trial.
Whether they can make the use of the drug beyond the trial added data for submission or not, I would think that they can at least discuss it with the regulators before the submission and make their point that way. It's unfortunate that better ways of determining benefit haven't been found, so the benefits that people see, or think they see, may be more based on hope than reality. The fact that the overwhelming majority in the trial remain on the drug certainly indicates that improvement continues to be seen.
I'm currently in a trial of a blood pressure medication intended to improve on what I'd been taking. My blood pressure wasn't terrible prior, but I would hit 140+ which was the minimum to be in the trial. Since being in the trials I rarely even see the mid 130's. There were placebos in this trial, but now all are on the drug. I believe I was on the drug from the beginning as my levels were generally lower from the time I started.
Gary
If management got the word on gaining approval now, what would they do?
I think they'd be smart to either announce the approval, or announce a webcast for before the bell over the weekend to maximize interest in the webcast. If they hadn't actually announce approval that PR would hit at, or just before the webcast started. That would give brokers following NWBO to work the news for the entire week, before it's no longer considered news.
This is based on what I was told by my old broker many years ago. Right now there are very few brokers who've ever heard of NWBO, but I suspect that will change dramatically the day they get an approval. Likewise there will be Institutions looking to get in big time.
Gary
I believe that Tesla is finding true competition in the many new electrics on the market in addition to Musk shooting himself in the foot by openly expressing unpopular views that have nothing to do with his cars, solar, rockets, robots, etc. Look what happened in Dubai yesterday and try to deny climate change. If anything, we need to accelerate the acceptance of electric cars, solar, windpower, etc. The speed of climate change is faster than most experts had thought, I hope it can be slowed, it won't be stopped unless something radical happens to the planet.
I'm very much a senior, it won't affect me much, but my kids are a different matter, and by the next century I suspect that much coastal property will either be under water, or protected by man-made levees etc. I have a boat in Marina del Rey, I suspect the sea walls and all the pilings that secure the docks in place will need to be 5 to 10 feet taller if it's not to be abandoned to nature along with a lot of coastal property in California.
Gary
I'd like to ask a question. Why does everyone blame Missling for problems with trial design or accomplishment as though he designed them himself. Looking at his background, his expertise is financial in the industry, not the medical side of the house at all. With 4 years of funds available, I would say that he's doing a good job on the financial side of the company. He's okay at presenting the science they've developed, but I doubt if he really developed any of it, or had much to do with trial design.
Ultimately he's the Capt. who's responsible for the ship, but with four years of funding, I believe he has the time to gain approval for their products in multiple indications and from several regulators. In more than one occasion I've seen the approval of products that failed to meet all trial requirements without further trials immediately. In some cases confirming trials were required, but the product could be sold while the confirming trials were being done. On more than one occasion it was the placebo's doing better than anticipated that resulted in the failure. I'm a believer that trials should be run against historical data so all who enter the trials gain the benefits, I suspect if the RETT's trial had been run that way we'd be openly sure of approval. The improvement noted in the placebo side appears to have been caused by observers hoping that they were seeing improvements, it's hard to overcome hope even if it's not real.
Placebo effects are real, and that's a problem, they're real, but they don't continue indefinitely, the drug will. As I understand it, observers who viewed placebo patients as improving over time realized it wasn't being sustained, but that was after the trial concluded. Perhaps the trial should have been much longer, but better still, make it shorter, give all the drug and observe the larger number of patients on the drug.
Gary
I don't really think most companies reveal even a small fraction of the meetings they have with the regulators, so I have no idea who they have, and haven't spoken with. I really don't know if the FDA is the best regulator to begin with on RETT's, in AD they clearly chose Europe because much of the trials were done there. I know the FDA is considered the gold standard, but they're also thought to be in the pocket of the BP's. I don't know that approval elsewhere wouldn't be smarter. As an American I've never liked the way the FDA operated, they have delayed numerous products that were clearly worthy of approval, and every such product that I considered worthy was eventually approved as long as they could afford to go the additional mile demanded by the FDA. Sadly I believe millions of patients lose the benefits they could have received if the FDA had approved, and perhaps removed any doubts with a conformational trial. I think they've gotten a little better, but still aren't the dynamic agency I think they should be.
Gary
Powerwalker, I agree, but the way I'd show what I had is by applying for approval to the regulators. I believe that even in RETT's they have sufficient data to take a shot and potentially they could gain an approval that requires a conformational trial. The development of an NDA is a major issue, but committing to get it done should be a big shot in the arm. I know that these things take many months, not days or weeks, to do, but to be successful they must be done.
Gary
I was in IMGN for about 4 decades, much the same was true much of that time, but it ended well, but frankly not as well as I believe it should have. I do believe the company is advancing toward approvals, it may not be this year, though it still could be, but in time they will come.
Gary
I found his presentation very interesting, perhaps others here knew about the growth of the media on charging, but this is the first I've heard about it. Does anyone know if space is created in the battery for this growth, or are they using some sort of compressible media within the battery.
The complexity in the design of batteries is nothing new. During WW2 a friend was a battery manufacturer. One day some Govt. Inspectors appeared to inspect his batteries, on watching them he could see they didn't know what they were doing, and he taught them how to properly inspect a battery. At that time tank batteries were failing badly, he was called in to determine what was wrong and helped determine what needed to be done to make them reliable again.
I find the idea of commercial electric aircraft in the near term to be amazing, I hope the companies that talk about it can actually deliver. I know at first they'll be short distant commuting aircraft, however with the sort of improvements that are being spoken about, I really wonder if in a decade or so transcontinental large electric airliners will be a possibility. If you can refuel most military aircraft in flight, I wonder if even that would be possible for recharging electric aircraft. I could also see the possibility of a small fuelled generator capable of providing sufficient emergency power to maintain the aircraft in slow flight while waiting to land.
Gary
Does anyone really understand what will happen when ZENA goes public. As EPAZ shareholders I believe we should see something, but I still don't know precisely what. I would hope that we receive shares in ZENA, perhaps only 1 share for 1000, or even 10,000, but something.
Thanks,
Gary
I was reasonably impressed by the presentation, but clearly the market wasn't. I know peer reviewed Journals take a substantial amount of time, but I gather the submission was many months ago, before I was an investor, I would think that Missling could be more optimistic than saying they expect it this year. I can understand him being frustrated with progress to date, and he's right, it's out of his hands, but if he said we're hoping for it soon, but certainly this year, it would sound far more positive.
I've gathered from NWBO's experience as investors view it that at least the UK regulators were working closely with the company prior to the actual submission. If much the same thing is happening with the Europeans, the regulators will know and have agreed on substantially what's in the submission. If this is in fact the case, the submission won't be made until all are happy with what's in it, but it should sail through it's review rather quickly. I don't know if this was in fact a rolling submission, or not, if anyone knows for sure I'd like to hear about it.
With 4 or more years of funding, I don't believe that there will be a problem achieving one or more approval well before funding becomes a problem. Approval could actually temporarily increase spending, but then revenue will kick in and it will become a net positive. I believe that Missling is playing his cards very close to the vest, but in time good things will be happening. I will probably be buying more, but am waiting to attempt to see where this bottoms out.
Gary
Is it possible that Dr Mulholland doesn't have access to DCVax-L without the huge payment and is awaiting it's approval.
Gary
I agree, and Amgen is certainly a leader, but I don't believe they intend to take things nearly as far as NWBO is. I'm saying they're looking to find markers found in many patients, and build products for those patients, but still a mass produced product. It will certainly be more effective than one drug intended for all patients regardless of their markers, but not as effective as a vaccine that's made from the cancer it's fighting intended for one, and only one, patient.
If you break a disease like say pancreatic cancer to ten separate groups distinguishable by certain markers it should be more effective than a single drug targeted at it. Together with DCVax-L it could make the difference in curing or dramatically prolonging survival.
I don't know that BP's will ever work to develop totally personalized products themselves, but I'd not be surprised for them to acquire companies that did, but I believe they'll keep them in wholly owned subsidiaries which may continue to develop new products. I suppose if they wished to do it themselves, they too could establish wholly owned subsidiaries essentially keeping the personalized products separate from the mass produced products.
Gary
If a BP offered stock, it wouldn't take cash to make the deal. Investors that want cash can sell at any time they wish, but the rest of us, and those buying their shares, end up with shares in a BP that should be worth a great deal because of owning NWBO, probably as a wholly owned subsidiary. Of course they could also offer cash and stock if they didn't wish to issue that many shares, I'd opt for the stock with the possibility of taking cash for what's in the Roth IRA's.
Gary
JFR,
We may not have access to the DTCC, but I suspect that if attention is drawn to illegal activity, the SEC should. I don't know if all this can add to what Posner already has going, but I suspect that if she's successful it may call attention to many things the SEC could take a crack at.
Gary
With us approaching day 120, and then only 30 more to 150 I've got to believe that patients following the approval deadline would await the deadline with their tumors properly preserved. If approved, they're ready to go, if delayed they can continue going for compassionate use.
As I see it, people who've very recently had surgery, or are about to, do have some time to get the vaccine. For the patients who're 3 to 6 months from surgery, they've probably applied for compassionate use if they've managed to raise the funds. I'm not suggesting that time is of no concern, but if you add the Poly-ICLC and/or Keytruda I suspect that getting the vaccine in 9 months or so after surgery gives the patient a very good chance of getting the benefit.
I think the bigger question may be patients who's tumor has been properly store, who're surviving, but where it's now a year or more from surgery, how does one establish the priority for making the vaccine.
Gary
I think the indication that such transactions would attract investigation by the regulators is an indication it's not all legal, but unless it's exposed nothing will be done about it.
Frankly things are far looser on the OTC than the major exchanges, and the SEC allows it to be, even more so on the Pinks.
If I were a short right now, I'd be bailing out of my position as quickly as I could without dramatically driving the price up. I know that attempting to learn what regulators are doing is common, but no telling if those with a major short position have any real indication of what the UK regulators are doing, or when they intend to announce it. Companies routinely don't provide information to investors using the excuse that they don't want to give the competition the information, meanwhile competitors have spies working within the trial and know exactly what the companies are trying to say is private.
If we truly have a massive short position, and gain approval, the short squeeze should be a thing of beauty. It needn't be 2 billion shares, if it's tens to hundreds of millions it still should generate huge margin calls and result in much higher peak prices, if there was ever a time to trade, this should be it.
Gary
There are many ways to do this, one would be considered a franchise, another a contract, the key is, no matter how it's done, NWBO will be paid for every patient who receives the vaccine.
I believe the vehicle that makes all this possible is the EDEN unit, and I very much doubt if the units will ever be sold. Rather they'll be leased and NWBO will be responsible for their maintenance and updates as deemed necessary. I believe every disposable cassette will be tracked from manufacture thru vaccine generation, and finally to its being recycled.
I know most here don't agree that the EDEN should be leased to places like research institutions, universities, hospitals, etc. but I still believe under the right conditions it may be. If I were the company, and if UCLA were continuing to make their own DCVax-L for use in trials that they're running to build DCVax-L's effectiveness, I'd provide them with EDEN's to get that job done which also would eliminate any argument as to any difference between manually made vaccine and what's made in the EDEN. Of course the other possibility would be NWBO making every batch of vaccine for them using the EDEN.
Gary
CO, by the time they're qualified to uplist, neither major exchange will care that while on the OTC they failed to have an Annual Meeting in 2023. Frankly at $4 or more they'll represent a company with a market cap of over $5 billion, far bigger than most companies at the time they apply to be on these exchanges. They will be a very different company than they are today.
As for a BP or other partner being necessary to grow, frankly with the right contracts for commercially manufacturing, storing, and distributing their vaccines, it's their contractors who could be doing the lions share of the work. I believe that Advent will be well positioned to do this for all of Europe, and CRL could potentially do it in most, if not all, the remainder of the world. It's up to the company how they want to go about this, but once the EDEN is available in mass the bulk of the business can be in the hands of these contractors. Tracking every disposable cassette from the time it's created until it's recycled will give them an audit trial for every batch of vaccine.
I'm not saying this is how they'll operate, they may grow dramatically and do it themselves. With a dramatically higher stock price and hundreds of millions of authorized shares still available to them, they could raise billions without asking shareholders to authorize more shares, so such explosive building growth is possible. Personally I believe they want to develop a huge market cap without becoming a huge company, with the EDEN approved and good contracts, they could do this with limited corporate growth.
I'm just suggesting that they have many choices. With approval, I believe they'll initiate both trials with DCVax-Direct to work it toward tumor agnostic approval, and on new trials for DCVax-L leading to a label change that's tumor agnostic. If they manage these trials, and allow contractors to handle the commercial manufacturing, storage, distribution and sales of DCVax-L they'll be well positioned for explosive growth. Of course they'll also be working for approval from all authorities, first the other three in the trial, but then expansion throughout the globe. Again, they'll use contractors in creating the changes needed to what's been created in approaching the UK.
Gary
I really don't know why age is brought up as an issue. This is especially true with our two major political parties selecting the oldest candidates in our history to run for President. There is no management position where the current holder of the position is irreplaceable if they either wished to retire, or if conditions demanded it.
LP deserves to take the company as far as she cares to, she's run the gauntlet and is closing in on tremendous success. If at some point she wished to retire, or diminish her duties, she certainly doesn't need to sell the company. A new CEO can be found, perhaps she'd want to be chairman of the board. The point is, she, and all other key people there, are replaceable without a buyout of the company.
With the UK approval, money will almost certainly not be an issue for those in management, or for many of us for that matter. A decision to retire or diminish their efforts won't be monetarily based, it will be based on their personal goals, and desires. As long as they enjoy doing what they're doing, and are in good health, they'll probably remain.
Many investors believe that with success NWBO needs to be substantially larger. They've gotten this far with contracting out much of what they've needed to get done, I believe they will grow, but they could also choose to contract out even more, possibly to a BP that partners with them.
Gary
You're right, it made little difference to the stock price. I do however believe it got a lot of attention from the thousands of oncologists, etc. who attend ASCO for information, few of them are investors. I would be surprised if more than a couple percent who looked at the webcast from the Experts Theater weren't already investors, or at least knowledgeable of NWBO before the conference.
If we have an approval before, the publicity about that may attract far more to attend the webcast, and probably attract many attending ASCO to attend live. Without approval, Newman may be right, they'd cancel, but I believe they would still pay and frankly I still think it's an opportunity to discuss where we are, and where we're going. If I'm right that they'd lose the funds committed to the presentation, I think they'll present.
ASCO Abstract Titles are scheduled to be released on April 24th so if anything has been submitted, we could learn about it then, the actual Abstracts are issued May 23rd. The ASCO Conference is from May 31st to June 4th.
Gary
Is it possible to build a 2 billion share short position in a stock with 1.2 billion shares outstanding. How is it done.
ChatGPT
Building a short position larger than the total number of shares outstanding for a stock is theoretically possible through various mechanisms. Here's how it could potentially be done:
Synthetic Shorting: Investors can create synthetic short positions through derivatives like options and futures. For instance, they could buy put options or sell call options on the stock. By doing so, they can effectively bet on the stock's decline without owning the actual shares. Theoretically, there's no limit to the number of options contracts that can be traded, so someone could accumulate a substantial short position this way.
Borrowing and Rehypothecation: Institutional investors or hedge funds with significant capital and borrowing power can borrow shares from multiple sources, including other institutions, brokerage firms, or even retail investors who lend out their shares through margin accounts. They can then sell these borrowed shares in the market, effectively shorting the stock. The process of re-lending borrowed shares to multiple parties, known as rehypothecation, can create situations where more shares are shorted than are actually outstanding.
Margin Trading: In margin trading, investors can borrow funds from their broker to buy or sell securities. If an investor has a large enough margin account, they can potentially short a significant amount of shares beyond what they actually possess.
Dark Pools and Over-the-Counter (OTC) Markets: Some trades, especially large ones, may occur in dark pools or over-the-counter markets, away from public exchanges. These markets often operate with less transparency and regulatory oversight, potentially allowing for the accumulation of very large short positions.
Synthetic Derivatives: Sophisticated investors can also use complex financial instruments to create synthetic short positions. For instance, they might enter into swap agreements or other derivatives contracts that effectively mimic the payoff of a short position without directly borrowing or selling the underlying shares.
It's worth noting that accumulating such a massive short position would likely attract significant attention from regulators and market participants. Additionally, executing such a strategy carries substantial risks, as short positions have unlimited potential losses if the stock price rises instead of falls.
____________________________________________________________________________________________
I don't believe we have the options or other derivatives available that Chat spoke of, but their answer does make it sound possible. I don't know if there are option markets that normal investors cannot invest in, but certain investors may, anyone have a feel for that.
Gary
Is this the calm before the storm?
We all seem to be set in our positions, waiting to see what the UK does, waiting to see the status of the EDEN unit, waiting to see when the company announces an Annual Meeting, etc.
Nothing we say can change any of this, but we all have our opinions of what's happening, but the facts must come from the regulators, and the company.
I'll restate my belief that the UK will approve on time, but I'll admit not knowing if on time to them now means 120 days, or if 150 days remains the target for this decision on their part. Early next week we're at the 120 day point, if nothing has been heard from the UK, I'll assume that they're looking at one month later. A decision can be made on any day, the company should be notified, then I believe they would have up to 4 days to notify investors based on SEC regulations. To me, if a positive decision cannot be announced by the open on Wednesday, I'd prefer it be held till at least the weekend, and rolled out in a way that maximizes attention to it. Other than an Annual Meeting or Expert Theater presentation at ASCO I cannot remember when the company has spoken to investors, or the general investment public. I have recently seen other companies get both good and bad trial news or regulatory decisions, in each case a webcast was announced at the same time the news was announced. I would hope that NWBO would have the same respect for investors and hold a webcast shortly after the news, good or bad. As a West Coast investor I prefer such webcasts during the market day, but I recognize that they're often held before the open. On more than one occasion the news was announced roughly one to two hours before the open and the webcast made a half hour to an hour after the announcement, I very much doubt that most investors were aware of it when it was live, but such webcasts should almost immediately be available for replay on the company website.
Speaking of the Experts Theater at ASCO, I would believe that once again the company will present there. What they have to say may largely depend on what does, or doesn't happen between now and then. I don't know if Abstracts were submitted for peer reviewed presentations of any of the other trials at UCLA, or elsewhere, but it's possible. Abstracts are due early February, new data may be added to the actual presentation, but submission must be timely. The Experts Theater isn't considered peer reviewed, but information that's right up to the minute can be presented there. If the company does what it's done in the past at ASCO, they'll have one of the larger exhibitors booth, and they'll have an hour to present at the Experts Theater, which has been webcast in the past.
Gary