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Thanks Mike,
When I look at the titles of what they're releasing in the UK it's listing all approvals made over a specific period of days. The question in my mind is on the day they approve, do they notify the applicant of the approval and if they do, can they announce it, or must they wait for the biweekly official update. I would think that if on say March 27th they approved they'd notify the applicant of the approval that day, but I don't know that to be the case. Does anyone know for certain?
Frankly a decision made to approve that's nearly two weeks before it's to be announced provides a substantial period of time where those making the decision could provide a tremendous benefit to friends and family if anything were divulged about the decision. I really believe the notification should be made immediately, first to the company, than by the company to the general public, but if that's not the case it really makes it possible for inside information to get out with an unintentional slip of the lip.
Gary
I agree that should be the case Hank, but the shorts have managed to take us down after the regulatory filing was made, I think it's impossible to ignore how well they've managed to manipulate the stock to date. I'm still of the belief that by mid-April we could have an approval. I don't know that the bashers won't keep us roughly where we are right up to the time we get the announcement.
If on the other hand we do get down to day 150, I suspect they won't be able to keep us below the $.75 to $1 range, but I'll admit being surprised by them many times before.
Something that none of us have mentioned in awhile is the peer reviewed article in Nature. I suppose if that comes out before approval it could spur higher prices even sooner.
I certainly don't know when, but one morning soon I expect to wake up and find I'm either already a lot wealthier, or will be shortly as the trading's been halted on news of the approval. Some of you will know it's coming before the market opens, but I'm rarely up at the open, and often not until the first hour or two of trading. If trading is halted, I suspect it will resume in an hour or so, at the longest, but as news grows I believe the price will grow from wherever they open trading.
As the shorts have to cover in the next few days I think we'll go higher, but eventually we'll retrench a bit then on to new highs.
Gary
Chiugray, you're right if there truly are 2 billion short if the shorts must meet calls. I'm not sure that much of the 2 billion isn't the MM's themselves, and I don't believe they are under any such rule, and I doubt if they must reveal their true position. Someone correct me if I'm wrong about that. Certainly if the MM's are the ones with a major short position they'll be hurting, but considering all they're working with, and the way the laws permit them to do things that others can't, I don't believe they'll ever have to reveal losses that are specific to NWBO and their other gains could offset these losses.
I really don't know how close the 2 billion short estimate is, if it's close to being right, and if it's not the MM's really holding most of it, it very well could lead to bankruptcy for some, though I believe traders must have a great deal of equity in something to be permitted to carry massive short positions legally.
It shouldn't be that long before we know. Once UK approval comes in, volume should go through the roof along with the share price, and I believe shorts will be given a couple days to cover. The short squeeze should keep the share price rising for at least a few days. I'm hoping that the company gets substantial media coverage and has other announcements that spur interest.
In the past few months I've had both a buyout and trial result announcements in other stocks. In most cases the announcement was followed by a webcast, often the same morning as the announcement. By the time people like me, on the west coast, get the word, the webcast is often over, but it's made available on the website. My point is, I hope the company opts to do such a webcast, and at that time I hope they also announce an Annual Meeting to further discuss plans for the future as shortly as possible after approval is established. Depending on whether anything must be voted on at the Annual Meeting I believe 10 days is the least notice, but voting lengthens the time which must be provided to nearly a month, and of course we must all get proxies and information on how to vote and the company's recommendations. If management can continue to keep the company's name in the news as they go for EDEN acceptance and additional approvals I believe our share price could reach the $5 to $10 range prior to the next regulatory approval, and we could have made the move to a major exchange.
If this all occurs this year, but we're yet to get the second approval, I'd say we've had a good year. More than that and it could truly be excellent. Once a price at or close to double digits is seen, I suspect a BP partnership could come at any time with the BP paying well into double digits for any equity position they take. With the higher prices I also think we'll see new trials announced and they may be started before the end of the year as well. There is plenty happening here this year for the company to become a household name if they're willing to work to get that recognition, let's hope that we see a lot of LP and others as we go into the second half of the year.
Gary
We are at T-58 today. In saying that I'm saying I expect approval at any of the next 58 days. All 58 days takes us to the full 150 days the UK plans to act within, but in the UK history they've had approvals within the last 60 of the 150 day time, so it can happen any day.
Druggie made the point that it will take 100 to 500 million share trading days to force the shorts to act, I don't know that it will take that much, but I'd like to see what volume people think will occur on the day we get word of the approval. I'll hazard a guess that it will come before the open, and trading may be halted for awhile based on an imbalance in orders. I believe that if the approval is widely publicized hundreds of millions of shares will trade that day, and for a few days succeeding it. In many cases, the same shares will trade multiple times in one day as day traders buy and sell as the price rises. We have over a billion shares outstanding, it's not impossible to have a multi-billion trading day while virtually all of us are holding and enjoying the ride, with computerized tradings some programs buy and sell in less than a second as I understand it, certainly in less than a minute. This occurs because computers have been programmed to take profits that often are just a small fraction of a penny, they can do that hundreds, or thousands or more times in one business day if the share price is moving in a way that meets their trading program. Personally I don't like it, but when you trade to four decimal places and have programs that profit on changes in the third or fourth decimal place you get such trading.
As for a retailer buying now, if they know for certain that tomorrow's not the day the approval will be announced, fine, wait another day. If however you don't know that an approval will come tomorrow, then you need to ask yourself is it worth the cheaper price I might be able to get to be out when it is announced. I believe that unless we get something that sends us up dramatically in anticipation of the approval, if it's truly a surprise, after a halt the shares will open at double to quadruple or more over current prices. It would not surprise me to close that day over $5 if media coverage of the approval is strong. If such strength fails to materialize, then somewhere around $2 is probable.
If you're a potential buyer, the question in my mind is, do you want to assure being in at the time approval is announced, if so, don't wait. On the other hand if you want to buy for perhaps a nickel less by T-20, or 10, or 5, take your chances. I believe the UK already likes our vaccine, they've seen it used often in compassionate use, and I wouldn't be at all surprised if we had approval by T-30, roughly 4 weeks from today. We're roughly 8 weeks from day 150, I'd guess that the chance of approval goes up by about 10% for each week. That's 80%, the 20% remaining represent the possibility of delay beyond the 150 days. As always, JMHO.
Gary
Chiugray,
I've never shorted a stock, but at the current price I've got to believe that most who are short would currently have a profit. The problem they face is if they wanted to acquire all the stock they're short, the stock would rise dramatically and they'd lose their gains. Clearly they don't want to do that, but I would think that they're bashing, to keep the price down, but buying to close their short positions, whether they can fully close the position, or not, I would think they're trying to get out of it. If the MM's are truly a big part of those shorts, which I believe could be the case, they would essentially purchase shares from investors looking to sell and diminish their short position.
Individual investors shorting will face the demand to clear their short position is they reach a point where their position is seriously under water, I don't believe the same is true of the MM's, they'll certainly have losses on the books, but they're not forced to buy to eliminate them. If they have gains on other stocks they've treated similarly they may not have a loss at all, just not as great a gain. If I'm right about this, the bashing will continue as long as a substantial short position exists, but the position will be shrinking. I don't believe that the naked shorting shows properly in any report of shorting as I believe it's largely carried out by the MM's themselves, and I don't believe they report the imbalances in the shares they're supposed to balance. I believe our regulators know what the MM's are doing, but essentially have given them the freedom to operate as they wish, rather than actually doing their jobs as intended. The MM's can virtually create tens of millions of dollars worth of stock with no one but themselves ever seeing the money, that was never the intent of the system, but when they short say a million shares, they bring in what those million shares are worth to the MM, and they're not selling those shares into the market, where they belong. The opposite is the case when the accumulate shares without selling them, normally to meet demands from Institutions that wish to purchase in multi-million share increments. This is no doubt a simplistic view of what they're doing, but it seems like the SEC is in almost no way policing their actions, so while they may have been created to keep markets fair, in reality it's unfair because they're almost constantly violating the laws that are intended to keep the market fair.
I have no idea if Posner's spoofing case against the MM's also shows that the MM's in some way are working together to maintain a massive naked short position that's not reported. I would suspect that it's inferred, but doubt if she can actually get the data from the MM's that would prove it. I really can't say that even the SEC can get all the data that's needed without a court order that would take time to initiate. During that time the MM's would be working to clean up their books. As I see it, any one MM can be short, or long a certain stock legally, but if all were found to be short, or long simultaneously, that would indicate they're working together to influence the price of a particular stock, and that's what would be illegal. I suspect that in our case most, if not all the MM's named in the complaint maintain short positions in NWBO in supporting an effort to keep the share price down. This effort, or course, supports hedge funds the MM's are working with, again probably illegally. Again, I'm no expert, this is JMHO.
Gary
I'm a new investor here, but in biotech's for decades, I'd like to ask how many here have actually participated in preparing a submission to the regulators for approval. I certainly haven't, but I've seen it happen in a few other companies and if there is one thing they all have in common, it takes a lot of time.
I doubt if Missling is doing much himself, other than administering his staff, and contractors he's hired, to get it done. A new CEO could do very little that's different. NWBO recently submitted to the UK, they made the mistake of saying it would be done by a date specific, then twice had to delay, largely because contractors, who they couldn't completely control, just needed more time, and on review some changes were recommended. It's far more important to make such a submission right than making it quickly.
The CEO essentially always gets the blame, or the credit, for what a company does, but in reality they have little they can do beyond establishing a capable staff and funding them to do their job. Change CEO's and you still have the same staff and the same funding needs. I'm not saying Missling's perfect, he's not, but replacing him would probably create more delays than it would accelerate developments. Every biotech but one I've owned complained about not getting enough information from the company. The one that didn't, CVM, I now consider a scam as when I invested decades ago they had one drug that they claimed would be the answer to AIDS and they even made the company symbol HIV until they failed there. Since that time decades ago they've promoted Phase 3 Trials against all sorts of different diseases, all with the very same drug. In short, they have a cure in search of it's disease. You really don't want a company that operates as they do.
The MAA submitted to the UK by NWBO was 1.7 million pages, and they already had approval for manual commercial production of their vaccine. I don't know that our filing would be nearly that big, but regardless, it's massive and it needs to be done right. Don't make it sound like all they need to do is change CEO's and it can be finished in days, weeks, or even months. The only way that could be true is if it was already at the point that it would be finished at essentially the same time.
Gary
Meirluc,
What you say may have some truth, but after UK approval I really don't believe the market cap can be held under at least a few billion dollars. right now we're under $600 million so I believe we'd be no less than 4 to 5 times our current price, and that's at the lowest.
With the right attention from the media, we could get into a feeding frenzy where people who've never heard of NWBO want in at any price. I've seen that sort of thing happen before and frankly with the right news, it could happen again. I have friends that would never buy NWBO at under a dollar, but if they wanted it at $5 or $10 they wouldn't hesitate because of the price. I believe that with the right news a sustained price of $10 is possible, taking our market cap to $12 billion or so, but it's doubtful a price above that could be sustained, and even that price would only be sustainable based on the picture being painted for NWBO of its future.tors
Certainly far more than $10 is justified on earnings once we have approval from all the regulators. It may take a little time to get there, but after all regulators have approved earnings in billions will easily be justified, and tens to hundreds of billions as the vaccine's proven to be tumor agnostic and should be used with many solid cancers is very possible. Perhaps as important will be the justified P/E which I believe should be 30 or more with earnings growing dramatically with each financial report. If we're only looking at $2 billion in earnings that's a market cap of $60 billion. Even if our share count rises to 2 billion it's still $30 a share. Depending on when we gain all regulatory approvals, I believe earning $2 billion won't take more than a year or two, that could put it in 2025 or 2026. Of course a partner buying in for double digit billions for a sizable position could accelerate the price substantially more.
Much of this has to do with perception, if we're perceived to have the potential of explosive growth, which I believe is a fair picture as long as tumor agnostic is where we appear to be going, the price can go higher. If it goes substantially above $10 on UK approval alone I'd probably set trailing stop losses and keep them a few dollars below the current price for at least some of my shares. I have friends who tell me I should sell at $2 at least enough to get my money out, I say why? Why take my money out when I still believe the stock is the best investment on the board. I'd say the same thing at $10, $20 or more. Why take money out if you don't need it, and don't have a better place to invest it. I know stocks retrench substantial parts of big gains, so if I sell based on placing trailing stop losses I'd look for the right price to buy back in after I believe the stock has fully retrenched, typically 30% to 50% of the gain. I'm hoping that by the time we're in double digits we're also on the option market. If that's the case I intend to write covered calls slightly out of the money when we've made a really large gain. I'd rather make spending money by writing covered calls than buying and selling shares. Of course this is in the future, but perhaps not more than a year or so into the future.
I hope I'm wrong and that with share prices in the $10's or more that most of us still maintain our positions, but it's rare that rapidly growing companies at prices like that aren't majority owned by Institutions. Certainly Institutions will take any new offerings from the company at that time, but to gain majority ownership, many of us will have to sell them our shares, and I suspect many will sell out, they'll be very wealthy, but can they truly find a better place to put their money. I'm certainly willing to sell at least some of my shares if I really have a better place to invest it, including the tax hit I'd take by selling. If my kids inherit my shares, they get them at a new basis and don't have a tax burden, unless the laws change. I can live very well by writing covered calls and never selling a single share, but only on a small percentage of my total holdings. Of course this money is purely for luxuries, our retirement annuities allow us to live well without the added income.
Gary
I thoroughly enjoyed one of the Flashman books I read, the author does a great job of putting Flashman into situations that otherwise are proper history. It's both educational and fun.
Gary
Chiugray, you may be right, but I just don't understand how the shorts would have an out with good news, if their short positions are growing, the short squeeze that will result from UK approval and other positive news will just increase the losses they'll incur. I know some may not believe that an approval is possible, I just believe that the handwriting is pretty clear on the wall that it will be approved. Shorts ought to be moving to the long side, and if it's the MM's themselves who're short, and they probably are, they'll suffer major losses, but not face the same kind of calls that individual shorts do.
To me, the upside potential is unlimited, the most you can lose on the downside is less than 50 cents a share currently. Frankly with what we know about using DCVax-L with Poly-ICLC and/or Keytruda, if we had a total failure in attempting approval without it, I believe the company would be worth far more than it's trading for today by a BP who'd take it into pivotal clinical trials with these combinations. I don't believe this will happen, but worst case it should be worth more than it is now if forced into a buyout scenario because they can't raise the funds needed to do these trials themselves.
I suspect a partnership can come at practically any time after UK approval, but it will depend on how the partnership is to be structured. I don't believe the company will sell more than a small share percentage in such a partnership at under double digit prices. A major partner, someone gaining say 20% or more of the company will require a share price much higher based on what LP's been quoted to say about it. I believe that was before I ever bought shares, but I believe it's still the case.
Gary
It could be in there, but I certainly don't know where and won't attempt to read every last word. There are few financial reports I'll do more than skim, and only certain parts there. I would hope this gets clarified, but it won't be by me.
Gary
Honestly Meirluc,
I believe that much will depend on how the media responds to a UK approval, and how the company treats it. If we get substantial media coverage, and if LP and others make appearances at Institutional and Brokerage conferences, etc and investors are being well informed about the advancements the company is making, we should skyrocket.
On the other had if coverage is mediocre, and if the company just keeps working, but doesn't tell the world what it's planning to do, then the bashers can hold down the share price growth, at least for awhile. Don't get me wrong, we should be in the $2 or so range, but claims from bashers like, the FDA will never approve, will stick unless the company has given us a plan for approaching the FDA. I'm fine with it not happening until the EDEN is approved, I'd just like to see that's the official position, if that's what it is.
Clearly I hope the company comes out swinging when UK approval comes, but I realize that the regulators abhor hype, so they need to be professional in their approach. I believe that they can get, or pay for, making presentations at conferences that gets the word out to the investment public. Many years ago, when IMGN was in its infancy, they'd routinely appear in BIO Conferences, I believe they paid to webcast from there, but it kept investors informed. I believe the company will pick up analysts, but they must webcast quarterlies and permit them to ask questions. In short, whether they can immediately upgrade to a major exchange, or not, they need to act the way they'd be expected to if they were on a major exchange. If they hold up in their shell, then the bashers can hold us down until more approvals actually occur, rather than in anticipation of what the company says will be happening as we advance into the future.
Gary
I agree with you Biosect, but the fact that we don't officially acknowledge that something is happening is hardly any better than the ostrich that puts its head in the sand when threatened. We really need to take on the threats, but few are willing to do it. Fortunately we do have Posner and LP who're willing to fight for us, and perhaps it will make a small change.
I believe in our democracy, but we're far from perfect. It can take years here to get the necessary permitting, etc. to build something that in China might be built in under a month. We need to make a lot of improvements, but we're still far more creative than places where people are not free to think for themselves.
I really believe our greatest breakdown is in politics. I don't care what party a politician is from, their job is supposed to be doing what's best for their constituents. That should mean they're working to get things done which requires compromises. Instead we have politicians who have allegiance only to their party line, and total disregard for doing what's best for the country. We can spend decade on issues like aliens, minimum wages, national debt, etc. without passing any meaningful legislation.
I hate to point the finger at attorneys, but the truth is we've become so litigious that costs go through the roof to avoid the possibility of being sued. A retired Dr. friends wife broke her arm in France. She was treated by walking into a hospital where they screwed the bones together and she was discharged, largely able to resume her vacation. She walked everywhere, never used a wheelchair, and her life was hardly interrupted. Here here husband assured me she'd have been cast, as the use of the screws could possibly lead to infection, she'd have been handicapped for months by the case, then had to go through physical therapy because of not using her arm for months. All this because in using the screws, which eventually were removed, the chance of infection was a greater possibility, and that could lead to a suit. Walking in a hospital could result in a fall, potentially another suit. During all my hospital time in treating the leukemia I was encouraged to walk the halls for exercise, yet when I check out, or need to go to another area for something, I must go in a wheelchair, or the entire bed moved, rather than just telling me where to go and letting me walk there. The fear of suits is infecting much of what we do, including all sorts of issues in clinical trials.
The benefits seen in our trial I believe were clear by 2015, if the clinicians and regulators had spoken with one another about what they were seeing and experiencing. By a year or so after adding Poly-ICLC and/or Keytruda the benefits there should have been clear. If people could just use their senses the approval of products like DCVax-L ought to have occurred nearly a decade earlier, and with 1.7 million fewer pages generated because the regulator should have seen, this works, nothing more than that should be needed to approve it. On a personal note, I'd not heard of NWBO at that time, so I'll benefit from all the delay, but frankly it shouldn't be this way. If the regulators seeing a benefit can't call something approved, authorize an EUA so the company can be paid for its use until the formal approval can be granted, or a determination made that something is better and it's use should be curtailed. Again, we don't do such things because someone might be hurt, and someone would be sued. It doesn't matter that hundreds of thousands have died of GBM in the nearly a decade that an EUA could have been issued and now, and many of those people might be alive today, but a few people might have sued if an EUA had been authorized.
I think our legislators and regulators might change things dramatically if they were the ones with the deadly diseases. I believe that Dr. Padzur's attitude has changed some since his wife died of cancer. It's not just the FDA that needs to change, they all do, but at least in the UK they did make DCVax-L available, but at a high cost.
The right to try program could work, but only if the price charged was agreed on without requiring proprietary information from the maker, and if insurance had to pay at least as much as if the patient was receiving SOC and other authorized treatments toward the experimental product. All who choose experimental treatment need to relinquish the right to sue the maker of the product, or regulator that authorized its use.
Gary
Many years ago all my trading was through a full service broker, I paid commissions on all trades unless it was shares from a stock offering, and I believe that markets back then were far fairer. I stayed in contact with that broker even after he retired and I went to Fidelity where commissions were much lower at the time, and became free. We discussed what was happening in the markets and why things like shorting and hedge funds that make money bringing others down were legal. The answer was simple, they were legal because if we made them illegal here, all that money would move somewhere offshore where they would be legal.
We didn't make them legal because they were the right thing to do, we made them legal because if we failed to do so it would simply end up in business leaving the US and going elsewhere. The only way to end such practices is to do so worldwide, and that simply won't happen.
I'm elderly, I doubt if all the ways we screw up the planet will have a great influence on my remaining years, but honestly I wonder if even that will be true for my kids, who perhaps could live another 60 or so years. Of course a WW3 could practically end it for all of us, but barring that I expect it won't be long before our oceans are flooding deeper into the population each year rendering certain areas uninhabitable, or requiring new seawalls to be built that can only last so long. We can slow it down, somewhat protect against it, but I frankly don't believe that we can totally reverse it. I suspect in just a few centuries the planet will have a very different look. My house, which is about 120 ft. above sea level and a mile or so from the ocean will be much closer to being waterfront property, if it's not already underwater. I suspect that California will be far more tropical, seawater temps will go into the 80's, and while this may make swimming in the ocean better, it will also bring in hurricanes' and tropical storms. The changes will be everywhere and frankly many places we currently live will only be tolerable if you're air conditioned almost all the time.
We can slow it down, prepare for it, but I'd be very surprised if we can turn it around. The key is first not making it worse, reducing how much we pollute, then trying to make it better. Things like solar, wind, electric cars, trucks, trains, and planes, and ultimately fusion power will be a tremendous benefit, but that alone is just a good start, there is a lot further to go.
Gary
Meirluc,
I'm only saying that the MM's, who are suppose to maintain balanced trading, are the only agencies who are authorized to have a naked position, but their job is to not maintain it. I'm totally against naked shorting, but I'm saying it's not being policed essentially at all.
Back in 2008, things were so bad with bank failures that Christopher Cox, the head of the SEC, actually said that for a certain period of time naked shorting on bank stocks would be prosecuted. Can you imagine having to announce that at some point I, the authority, do actually intend to enforce the law.
We're supposed to be a nation of laws, to me, if a law isn't going to be enforced, it should be stricken. I'm for reasonable enforcement, if all cars are driving at 85 you don't ticket one, but if one is driving 85 and the remainder are 75 or less, ticketing the 85 is the right thing to do. In our case I believe it's true that our price is being manipulated far more than the average company, those doing it should be punished. I hate to say it, but agencies like the SEC don't seem to care, especially when it comes to OTC or even worse with Pink stocks. We need people like Posner to keep the MM's in at least a little control.
If we ever really want to achieve fairer markets we need to take a step backwards, widen the bid and ask so computerized trading can't profit on $.0001 differences, or even $.001. Years ago 1/32nd of a dollar was about the smallest increment between bid and ask, and often it was as much as an eighth or even a quarter, that's of a dollar, not a penny. Markets were under much better control and not dominated by computerized trading. Of course back then computers the size of a good sized room had less power than our phones. I just think we've made changes in the way we do thing because of computers because we could, not because we should.
We have made hedge funds, companies looking to bring down other companies, into a major industry, it ought to be totally illegal, but it isn't. Some of the highest paid executives are hedge fund managers, it's not salary, but bonuses on what they earn that make the position so lucrative, but what they earn is often based on how they bring other companies down to make their profits.
We're now at T-59.
Gary
I'm certainly no expert, but if you go for Complete MA, isn't it still very possible that the regulators will approve with conditions anyway. The only way I would think you'd go for Conditional is if going in the only way you think you can gain approval is by offering conditions you'll meet on the regulator granting such approval. I.E. if you know you have to run additional trials, concede it up front.
In the case of many products, new trials will be needed post approval for label expansion. I see no reason not to say that if it's already acknowledged to be the case.
Gary
You may be very right that someone else would have done better, however if in time he gets the job done, he'll still be credited with the success of the company. He had been at IMGN before, and probably reacts like nearly all IMGN's CEO's have acted. I was there for decades not because I liked the management, I didn't, but because I believed in the technology. I opposed the buyout, but clearly management had the Institutions behind them and sold out at the first opportunity to do so and make a nice gain. I profited nicely, but still believe it should have been worth substantially more if they waited longer to establish a revenue stream for Elahere.
My point is that in most successful biotech's there are times when management is put down terribly, but if approvals are gained they're toasted as heros. NWBO is my biggest holding, it's heavily bashed and is going after the MM's for spoofing. Many put down the CEO, but frankly I believe that many others would have thrown in the towel long ago, so I very much support her. I believe we'll see UK approval in the next two months, the other regulators including the FDA by next year at the latest. It's worth looking at, it's vaccine which is personally made from the patients tumor will be shown to be tumor agnostic in time, if it's not acquired no telling how far it can go.
Gary
I certainly don't know, but I believe that with the recent weakness in the price the shorts are working their way out of their short positions.
As long as the substantial bashing continues I think it's clear that a substantial naked short position still exists, and if as suggested it was ever near 2 billion shares it cannot be eliminated very quickly, but nonetheless I suspect that they're working their way out of it. If most the bashers go away, I think we can assume the position has largely been cleared.
If we gain UK approval, and bashing continues, while I don't believe it can be very effective, they'll be struggling to clear their short positions at what clearly will be much higher stock prices. Griffith and others are not fools, but if Posner is capable of determining that they're closing a major naked short position it should strengthen her position in the spoofing trial. It should also work to get the SEC looking at the actions of the MM's.
Over short periods it's completely legal for MM's to have naked short positions as they're supposed to balance demand and supply and may do so under the guise of maintaining this balance. To my knowledge they're supposed to work their way out of such positions, but there seems to be no consequences for them not doing so. Many years ago a company I was invested in went on a Russell index. After hours the day they went on the exchange millions of shares traded as Institution who had to have shares of companies on that Russell index loaded up with shares at the market closing price. Simultaneously a multi-million short position was established, that's legal, but I really don't believe what happened thereafter was, that short position never was significantly diminished, it remained for a couple years when the company came off the Russell, then it disappeared. I don't know if one, or many MM's had maintained that short position for years, but clearly it was a naked short and effectively they'd created hundreds of millions of dollars worth of stock that they company didn't see a penny from. I cannot say how much better the company may have done had this not occurred, but it clearly was happening and the SEC or others never took an interest.
Let's hope that Posner is able to put this all together and in time the SEC takes an interest, but not until after she settles the case for NWBO as the last thing I'd want is the SEC delaying Posner's actions.
Gary
Doc, I don't believe that pseudoprogression was an issue with those on the SOC, I believe it was purely for those who got the vaccine who were thought to being progressing, but who actually were getting better, IE pseudoprogressing. Those on the SOC who never crossed over were simply too sick or passed on before they had the opportunity.
This scenario creates K-M curves which show patients on the vaccine progressing before those on the SOC do, but it's because their pseudoprogression was called progression and that call was never reversed, even though the patient continued to improve, and may in fact be living today. It's rather like a totally incorrect call in a sport activity, once the call is made it becomes official no matter how wrong it is.
I'm frankly uncertain today if a new trial were established whether progression would be a legitimate goal because they now have an acceptable way of differentiating between progression and pseudoprogression during the trial. I don't know if some sort of intrusive activity, like multiple needle biopsies of the tumor, would be considered acceptable for differentiating between progression and pseudoprogression. If some sort of scan cannot make this determination, I believe the only goal may be overall survival, which is the gold standard, but clearly takes longer, and costs more.
By the way, by my count we're at T-59 for UK approval.
Gary
I still believe that we should have a position in Zena based on our holdings in EPAZ,. Does anyone disagree?
Gary
I understand what you are saying, but the great CEOs are the ones who like Missling took on a fledgeling biotech and took it to success. Are you really certain that Missling can't do the same.
Every biotech I have ever invested in had the same complaints about management, but in time they either got better and gained approval, or theey were replaced or went out of business.
If they get the regulatory filing in they'll be potentially closing in on success, I think it's worth waiting for.
Gary
I've seen little of Oregon, but I'd hazard to guess that Newport, Oregon is a beautiful place, buy not a harbor like Newport Beach in CA. I gather there are few harbors until you reach Washington, but some great salmon fishing in the streams that run to the ocean.
Gary
On the subject of Coretec, I believe we need to see a quarter or two in the new organization before we really know how this is going to work out. I'm considering purchasing more, but haven't made up my mind. I welcome others thoughs.
Gary
I agree with you completely on plastics, you can practically walk on the plastics that have accumulated in the gyre areas of the ocean.
We live near Marina del Rey and I've been in charge of our yacht club's cruise to Newport Beach for years, do you live near Newport. Sounds like we have a lot in common. I've helped with cleanup in the marina too.
I suspect that microplastics have contributed to the rise in cancer and other diseases, what's really needed is something that digests it harmlessly, but I don't think that currently exists. Personally I've had 3 notable cancers in my over 80 years, leukemia with stem cells was the most serious a decade ago. I don't know if anything is due to plastics, but it's clear that it can't be good for any living thing. It's sad that we have politicians who fight cleaning up the man-made pollution that's adding to our health and climate woes.
Gary
If they removed sufficient cancer and properly preserved it they could make DCVax-L. The way the announcement was made it sounded like they failed to find the cancer during the extensive surgery, and if you believe it, it was after she was released from the hospital 2 weeks later that cancer was found. If that's true, I would think their was very little cancer in what was removed, but frankly it doesn't sound like what they're announcing really happened that way.
I doubt very much that they would use DCVax-L even if they had sufficient material properly preserved unless it previously had been successfully tried in the compassionate use work that's been done in the UK on at least a couple patients with the same form of cancer. Of course we don't have an accounting of what has been done in compassionate use, but Dr. Ashkan and others no doubt do.
The fact that the King and Princess are both being treated for cancer ought to bring added attention to work being done in cancer there. I doubt it will accelerate the approval of DCVax-L, which could come in the next 60 days, but when it's approved it may get more attention. JMHO.
Gary
The UK target for completion of the trial is approximately 60 days. I believe that it is now possible to gain approval any day and conshisider this to be T - 60.
Gary
I believe that the latest guidance not only permits you to go to Phase 3, if the protocol is essentially unchanged those in the Phase 2 trial becomes part of the data for Phase 3.
Gary
John, I'm for anything that helps to clean up the planet, but I believe the place we can make the biggest difference in is being ignored, the oceans. I've only had a basic oceanography course, but in it one thing was clear, something like 80% of our oceans have virtually no life, and therefore no photosynthesis at the surface because all the nutrients are down 400 feet and no upwelling is occurring. I believe that simple artificial upwelling units could bring nutrients to the surface and sunlight could do all the rest. Besides plankton, turning CO2 into carbon and oxygen, it would be easy to also set up kelp forests, and then establish fish farming in these areas with plentiful nutrients, plankton and kelp. In some ways it would also tend to counter global warming as colder water below would be cooling the warmer water at the surface.
Someone more knowledgeable than me needs to look at this, but it really doesn't require much energy to pump water from 400 ft. or deeper to the surface, I really think something like the duct off dryers, but over 400 ft, long could do the job. A small compressor could send air down to an airstone perhaps 25 or so feet down and just keep the water coming like in an aquarium, I just don't know how large an area the nutrients would spread out to, but believe it could be substantial. It would take many artificial upwellers, but they could be solar powered but if I'm right our oceans could deal with many of our climate problems and be generating a lot of food as well.
Gary
Based on the FDA guidance in a Journal article they authored, no control will be needed in further such trials.
I believe in the next few years you'll see most, if not all new trials against terminal and vary serious diseases use historical data to establish a base to be improved on with all patients getting the experimental treatment.
Gary
I believe you could be right, but it can't happen until after at least UK approval. I believe the share price would need to be at least in the $3 range and would suspect that we'd need to authorize more shares at an Annual or Special Meeting in order to gain the authority to do such a buyout or merger. Oncovir, as a privately owned company, wouldn't need to gain any shareholder approval, but I believe NWBO would, but it ought to be a sure thing if they have to put it to a vote.
The key, as always, is approval and developing a revenue stream, the ownership of Oncovir would build that revenue stream faster, and if thoughts of a buyout come true, it would be at a dramatically higher price.
Gary
If this is completely correct, approval could come on virtually any day over the next few months. I believe that others have shown that some UK approvals have come in as little as 3 months so we're now officially in that window. Could you imagine what would happen to shorts if virtually any market day the company announced UK approval. I'm uncertain if they would announce mid day, or before the bell after they know, but regardless, I believe based on current share price trading would be halted based on an imbalance in orders and when trading resumed the price would be more than a double, perhaps even 4 to 5 times the current price when it opens.
Perhaps this wouldn't have happened if the share price wasn't manipulated so low, but the reality is, it was, and now anyone still short the stock is in for a rude awakening. The short squeeze itself will send the share price higher than without it, but such prices won't be sustained unless other positive news comes on the back of UK approval, and that certainly is possible.
I believe that as soon as approval is announced the company will announce either a webcast to discuss it, or schedule an Annual Meeting, which I believe they must allow at least a couple weeks, they might very well do both. It's possible a webcast is announced with the announcement of an approval and trading could be halted until after the webcast if it were scheduled before or shortly after the market open.
Personally I'd love to see an announcement after the close, as someone living on the West coast I rarely awaken at the open. I'd like to be awake and listening in on the day approval is announced. Of course it would also be a thrill to wake up to say a price of $2 or more a few hours into the market day, I'll take it either way. I believe after the company is notified, be it good or bad news, they have some discretion on how they announce it within some limited number of hours. I would hope that the company already has a plan of action for how they'll keep NWBO in the news after approval has been announced.
Gary
Thanks John,
At the time I would think it was all about the company without Core Optics, it should get even better now, but of course the investors at that time only will own 20% of the company. I really believe if the battery technology is utilized by many battery makers, that side of the house could be worth more than the Optics side in time, but right not it's the Optics that are bringing cash into the company.
I'm intending to purchase the 2025 Mustang Mach E because it will have the improved battery and Tesla plug, as well as styling changes and other improvements from what I've read. I doubt the coretec media could be included in the battery, but would be thrilled if it were. I suspect it will be the 2026 or 27 model years before some of the biggest improvements in battery tech will be available on the market, and it will continue to get better. The question in my mind is whether they offer a car with 600 to 1000 mile range routinely, that keeps battery weight heavy, or look to lighten the cars, maintain ranges of 400 to 500 miles with charging to 80% in 5 to 10 minutes. I frankly think if I could rely on 400 miles and a 10 minute charge as long as most places like rest stops and fast food restaurants had high speed chargers.
I believe that all the automakers will profit nicely while converting from gas to electric power, but service requirements will be far lower and that will hurt dealerships, most like Tesla may give up on traditional dealerships. For most drivers the batteries will effectively be lifetime batteries.
I've never leased a car myself, but if the Govt. still offers a $7000 discount if you lease, but not if you purchase an electric, I'll lease than buy it out of the lease, perhaps after just a month or so. This is an incentive that should be changed, but a friend just leased a Mach E to get the $7000 discount on the price, not available if they purchased. I'm very much a senior, so I'm thinking my next car will be my last new car, but who knows, maybe leasing and getting newer whistles and bells 3 years later might be a nice way to go if money's of no concern.
Gary
Thanks for your earlier research on share count, but I really believe all that any of us can do is either go along for the ride, or sell. Of course we can also choose to add, frankly I continue to think about that.
The good news, from your analysis, is that the company doesn't need to take dramatic actions to deal with what's been agreed to in the terms of the merger. With currently authorized shares if they wished, even a small R/S say 2 for 3, would bring the total above what's needed. It can easily also be done with a small increase in the authorized shares.
I believe the real question is, how much do they need in earnings to justify a major exchange listing with say 1.7 billion shares outstanding. If we look at a P/E of 10, we'd need to be making $170 million annually, at 30 it's roughly $57 million for a $1 share price. $1 could move us to the AMEX exchange, but if we want the Nasdaq or NYSE it's 4 times that, or more. Is it possible, most definitely, but we really need to know what Core Optics is contributing, and sell one of the major carmakers/battery manufacturers to go for our battery media.
I don't know what others thoughts on our battery media's potential is, but I believe it offers billion dollar earning potential in time. How quickly can that happen, if we can make product available, very quickly.
This only is saying that IMHO it's possible to move the company to a major exchange without a R/S if the business is there to be making hundreds of millions annually. If that's not possible, and a major exchange listing is demanded, then a R/S is most likely the vehicle for getting there quickly. The key is convincing the investment public that it's the right move so the company isn't punished for doing so.
Gary
Thanks Margin Buu,
Many of the posts about Mr. Sarma make it sound like he's got major influence in biotech in India. Other than the fact that he came from there, I don't see it in what's publicly available about him. No doubt he has contacts in India, which certainly could be a good thing, but unless nothing is public about it, he doesn't appear to have relationships with BP's or biotech's in India.
Clearly he's quite wealthy, owners of sports franchises are in a unique club of their own.
Gary
Everywhere you look T-cells keep cropping up with benefits, whether it's CAR-T or modified T cells it's big news. Of course there has been some problems as well, like curing one cancer, but apparently initiating others. The administration of CAR-T can be dangerous as well, a patient I met hit 107 before they brought his fever down.
We may not get precisely the same reaction as CAR-T, but CAR-T is short lived and does have negative side effects. We on the other had generate substantially more of the patients T-cells and that increase is sustained. We really need more data to know this is happening with all the different solid cancers we treat. I'm no expert, but I believe your own T-cells in greater numbers can't help but fight all diseases in your system, not just the cancer specifically. Many cancer patients don't die of the cancer, with their weakened systems they often die of pneumonia. I'd suspect that the greater T-cell population would work to fight off that pneumonia.
I've often said that our vaccine is not a monotherapy that will cure cancer, or any other diseases for that matter, but I believe it's one that will prove to be one of the treatments that leads toward a cure. We know in GBM the addition of Poly-ICLC and/or Keytruda make it far more effective, but neither are effective without DCVax-L. There may be others that should be added, or that could be more effective than these two, the point is, you only know by trying.
I believe that very few experts would argue that increasing the output of your own T-cells isn't a good thing. If it's proven that we're doing that in many forms of solid cancers no telling how far our success may go.
Gary
I note that this is your first post on NWBO, and only your second post in years, but I'll hope that you know what you're talking about, and will be more active in the future. I was wondering if with over a decade of ownership our new board member had ever posted here, I hope you're correct that he has, even if not too recently.
I took advantage of the share price and got another 10K this morning. I certainly don't know how low we may go before we turn around, but I don't think it's much further. When we do, I'd not be surprised to see our price double or more in a matter of days, perhaps even one day on the right news.
Gary
I certainly don't know, but believe that they're trying to make everything happen by March 31st so the next quarter begins with the merger complete and will offer a clean view of the company when quarterly results come in for the 2nd quarter, late July or early August. I tend to believe that it's likely we'll have a R/S, but hope it's just a small one, in the 1 for 2, 3, 4, or 5 range, if they can keep it at that level and take us to a major exchange in time, we'll have done exceptionally well. I'm hoping that their target for such a move is by the end of the year, that gives them the time to grow the earnings to justify that price.
Gary
I've recently seen NWBO doing much the same thing. I believe that they've worked closely with the 4 regulators involved with their Phase 3 trial, but in choosing the UK to go after first they were choosing the regulator most likely to approve the quickest. They're a much smaller company than Anavex, and they've used contractors to do much of the work. I would suspect that it's the case here as well, and likewise they're going to the first regulator they believe will get the fastest approval in each indication.
I think it's a positive that it's the FDA they're speaking with on RETT's, far from a guarantee, but an indication that they believe it's possible. The FDA isn't about to tell them that if they submit, it will be approved, but they may encourage them to submit so that they can review it in greater depth. If they suggest doing further trials they're essentially saying that a submission would certainly fail. It's very possible that after reviewing an NDA they'll ask for further trials, but it's also possible that they'll conditionally approve, with confirming trials required while they're being paid, and of course it's possible they approve with no conditions. The question is what they're told by the FDA.
Many years ago IMCL, the developer of Erbitux, was telling the world that all was well with their Phase 3 Trial with the FDA, while the FDA was telling them of shortcomings in the trial. It resulted in a $3 billion partnership with BMY before they announced the FDA had rejected their filing and insisted on further data. This is the case that put their CEO and Martha Stewart in jail for insider trading, but ultimately Erbitux was approved. It changed the laws so the FDA could speak out if their position is being misrepresented. Generally few companies say little about what they're being told by regulators. I believe the others pretty much follow the FDA so you don't want to risk saying something, and having a regulator correct what you're saying. Better to say nothing until you can say something official, like our product was approved.
Gary
You'll see her when she is ready, but not a day before.
Gary
They still have to get EDEN approved, but that appears to be just a matter of time.
Gary
With worldwide cryogenic shipping possible in a matter of days, it would be possible to operate from a single site. On the other hand, with the EDEN Unit it would be possible to operate from thousands of sites that already have cryogenic and other required capabilities. It is really up to the company as to how they choose to operate.
Gary