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I don't trust the MMs with market orders ever, I have seen them drop the price substantially to get stock cheap and take it right back up immediately. I don't know if the investors can ever recover from the way they manipulated them.
Gary
I believe that we all have our happy place. I'd like to see a million in NWBO in my account, that would make me happy, but I think that it will go much higher than that, hopefully this year. Where is your happy place.
We're at T-55, early next week I think that we'll see the next UK report on approved products in the last few weeks. I doubt we'll see NWBO'S name there, but it will not be long before we do. I hope to be happy then, or possibly shortly thereafter.
Gary
We're at T-55. Awareness is growing that we're heading toward approval.
Gary
I agree with you and so does the company in what they're saying, but people feel quite sure the UK filing is for brain cancers, not tumor agnostic.
Frankly I doubt we could deliver in sufficient quantity if we got tumor agnostic up front, let's deliver on brain cancer, add some others as off label treatment and build capacity to meet the coming demand.
As for DCVax-Direct, if it's injection into the tumor is essentially making the equal of DCVax-L in the tumor, I wonder if the trials for it ought to be combined with Poly-ICLC and/or Keytruda to improve its performance from the get go.
If the FDA and others would allow negotiations on what's charged under right to try, without gaining proprietary information companies aren't willing to give, patients wouldn't have to wait a decade or more to get great products because trials and approvals are taking that long. It seems that the potentially millions who could benefit from experimental products would at least have a choice. It's sad, but they don't seem to care about the millions who can't get the products over the years.
Gary
Karlchen,
I'm of the belief that they can go for a tumor agnostic label with a single trial that's targeting several different cancers, though I don't know this would be a fact, nor do I know if they could list a variety of therapeutics to supplement the DCVax-L which experts in the different cancers may wish to choose for maximum benefit. I don't know, but believe that Poly-ICLC and/or Keytruda may not be the best choice for all cancers.
I believe that Drs. will choose to do some off label treatment, but gaining insurance coverage will take substantial evidence. I don't know if it couldn't be documented in a trial faster, even if the trial is only partially completed and the evidence comes from taking a peek, or the DSMB being open about the improvements they're seeing and ending the trial early.
I suspect that we may do at least a few trials that cost the company nothing because other companies want to prove their product greatly enhances DCVax-L's improved outcome and they're willing to pay for the trials, possibly even purchasing the DCVax-L, or we might co-sponsor the trial by providing the DCVax-L. At UCLA I believe they were doing the trials at no cost to NWBO, but may very well have had funding from other agencies. Where Keytruda and/or Poly-ICLC were used I can't say if they paid for them, or they were provided by the maker.
Gary
Great post Chiugray,
Of course the only way to really know the worth of NWBO is to continue and expand trials with its products. One extreme is that it only works in GBM and DCVax-Direct doesn't work at all. The other extreme is that both DCVax's work, and should be a part of the SOC in practically every solid cancer.
Aspirin has been around for over a century and they still find new ways to use it. I can imagine that 20 years from now they'll find new ways to use the DCVax's and new products to use in combination with it to make the treatment more effective. I suspect that it will take the better part of a decade for all the results on trials that are initiated in the next couple years to be completed and evaluated, but when approved, both DCVax-L and Direct will be used off label based on anecdotal evidence that shows its benefits.
What does this mean wrt a buyout. To me it's saying that the longer the company waits, and the more they learn, the greater the price will be.
If LP sells before further trials have been done with DCVax-Direct it's likely that they buyer would be stealing the company, no matter how much they paid when compared to the earning potential of the products they're receiving.
Gary
My mistake, I thought that if they had a contract that they could build the batteries.
Gary
Perhaps it depends on how you get your CNBC feed, on my phone the trade time reports as the current time and I know I saw trading right after the open, not 15 minutes after. When I go from the list to the more detailed quote it says RT quote.
Gary
What needs to be completed with Endurion, I was of the belief that if a battery maker wished to license the use of it in their batteries they could do so today. Am I wrong about that.
Thanks,
Gary
I didn't look in that much detail, but it's clear they have plenty of room for growth or even taking in an equity partner without needing to ask investors to vote to authorize additional shares. It seems like many here are looking forward to a buyout, short term it's a great gain, but I believe they often occur before tremendous share price growth would occur if the company continued to operate independently. We both observed that in IMGN and frankly I think it's true of many of the buyouts that shareholders welcome.
Gary
I believe CNBC was showing quotes immediately after the open, I don't really think they're delayed on my Android device. It says it's a RT quote.
I trade on Fidelity, but frankly find the CNBC site more friendly for watching many stocks that I don't own in my Fidelity account. I could probably set up something different from them, but CNBC has worked well for me.
Gary
Today would be day T-56, roughly 6 days till the next release of authorized drugs from the UK. While it's doubtful our name will be on it, it isn't impossible. It would certainly be a shock to all here, the longs would clearly be thrilled, the shorts in real trouble. As for the bashers, if they don't have a position themselves, and are only the agent of shorts, they'll just keep doing what they're being paid to do, though I suspect some paying them may stop, others may actually intensify their efforts. Time will tell.
I'll try daily to remind us of the T-number, the time to when we hit the day 150 that's the UK's target for acting on products getting priority review.
Gary
I think we all should be perfectly clear about not wanting a buyout at this time, or for the foreseeable future. Why? Because no company in its right mind will pay nearly as much as LP, and most longs here believe it's worth. The BP's are only too happy to circle like vultures and pick up companies with promising products, but which simply don't have the financial and other support needed to take the product over the finish line and gain approval. Others besides LP might have done this years ago, and investors would have probably seen double the current share price, and at some times that may have been $5 to $10, more recently it would have been much lower than that.
I certainly don't rule out a buyout in time, though personally I would prefer an equity partnership with a BP at the right time, but IMHO either partnership or buyout should be at least in the $20 a share range, and preferably $30 a share or more. My experience says it's very rare to achieve an offer at over double the current price, so that's saying that I don't see such action occurring until we've achieved at minimum a low double digit share price.
This doesn't mean that we cannot partner with a BP, etc. in co-sponsoring a trial, perhaps even permit them to take a tiny equity position, but not the 20% or more of the company that potentially could give them control of the company in time. I believe the potential exists for many trials that include other companies products added to DCVax-L, it's very possible that other companies may pay substantially for these trials, even possibly paying NWBO for the DCVax-L used in the trial, rather than having NWBO paying for part of the trial, it's up to the companies involved to determine how the trials will be structured. Once we have an approval, I would think the company could sell DCVax-L for use by others in trials, but probably limited to where it was approved. As always JMHO.
Gary
As a newer investor I certainly have much to learn, but I sense a great deal of concern from some investors about long term funding. I briefly looked at a few places but couldn't determine the authorized shares. As I see it, if the company is right up against the authorized shares, as long as they justify their actions, I've got to believe shareholders would authorize more shares. If they're not right up against the authorized share limit the company can raise funds without coming to the shareholders.
I know some shareholders dread dilution, I don't as long as I see the reason is justified. Obtaining regulatory approval for products in development is certainly a justification in my mind. Sometimes being frugal, and not diluting, is worse as it's often done by slowing the process to approval. I'd rather see a company dilute if by not doing so approval could be delayed a substantial period of time. Certainly it's a balancing act, but dilution should not be considered the end of the world.
Gary
What disturbs me is the fact that IMGN finally had a wholly owned approved product and each quarter sales were growing. The confirmational trial had great data, and in fact was approved last week. If they held for 6 more months I think revenue, and therefore price would have been dramatically higher. After four decades in business they could have taken another 6 months or so before going out of it.
Gary
Do you know if he's going after the UK as well. I believe both UK and EU's files are pretty similar, of course they were together until Brexit. NWBO is going after the UK as that's where their commercial manual manufacturing is and I really believe they need the approval of their EDEN unit to go much beyond the UK. I expect UK approval in the next two months so I see it as a big opportunity right now.
I have a feeling that Missling is like NWBO's CEO and able to keep it together on a shoestring until he gains an approval. Hopefully it will happen later this year, but if not, I suspect he'll find a way to do what's needed until he achieves that initial approval. IMGN operated much the same way, there was one period that they only had enough to pay people for two weeks.
The best such story was the CEO of FedEx not having enough to make payroll so he took what he had to Vegas and got lucky. It might be a very different world had he crapped out.
Gary
I really was unhappy with the buyout and spent some on just out of the money calls in hope that it wouldn't go through. I did make a nice profit, but after all those years really felt it should have been worth more.
Those were fun days, I've not heard from Allen or LarryMacc for years. Ed occasionally kept in touch, and of course who can forget the Cheesebeast.
I don't know if Mitch is still around, if he is I think he's well into his 90's.
Gary
Did you forget to use your other ID?
By the time a deal is done with a BP, or anyone else, NWBO should be on, or applying to, a major exchange.
Gary
If a company partnered with NWBO or a major financing occurred, a seat on the board should certainly be a possibility. If a BP were to take a major partnership position, say 20% of the company, or more, they would almost certainly get multiple seats on the board. Effectively such a partnership would give them a great deal of control, especially as Institutional ownership grows. With the support of Institutional owners a BP that owned 20% of the company couldn't be stopped in an issue it brought to a shareholders vote. I'm fine with partnerships, but I really don't want to see major equity sold until we're selling well into double digit share prices.
I know many believe Merck will at some point be our partner or buyer, if so, I hope it's not until we're selling for $15 or more, so they can justify paying $30 or more for the stock. I would not be surprised with the acceptance of the EDEN unit if some agreement were made with CRL and it could involve a small equity position, say 5% or less, where CRL becomes a major commercial producer of the vaccine as well as taking care of it cryogenic storage and distribution. I would hope that CRL would bring in a billion or more but it wouldn't be just for the stock, it would also be for the rights to lease the EDEN's from the company and producing the vaccine for them. On a share basis this might be in the $30 range, but the shares would be just a part of the deal, so you'd have to consider the price per share being lower, but other things considered in the cost. CRL would make their money back many times over with the sale of vaccine they'd be manufacturing, storing, and distributing.
Gary
I haven't been here long enough to honestly judge him, but I believe it would all turn around in his favor if the Journal article came out and a filing was made for approval by at least one of the regulators. I'll take him at his word that these things are in process, however until they happen he's not being seen as getting anything done.
I know he came from IMGN and essentially they way he's operating is how IMGN operated. Investors never like how much time things take, and frankly they often take longer than most CEO's think they will. IMGN's first CEO was Mitch Sayare, he often used soon in discussing when something would happen. When Mitch said something would happen it eventually did, but when he said it would happen soon, soon might be two years later. It got to the point that in our posts we'd spell it backwards in caps, IE NOOS.
Mitch at one point took our phone calls and posted on Silicon Investor, but he got in trouble with the SEC for doing so and that ended. I stuck with IMGN from its beginnings and did get a reward in the end, but they really shouldn't have sold out when the did, on finally achieving success with a wholly owned drug. I believe if they remained public 6 months to a year longer they'd have roughly doubled the buyout price.
I doubt if Missling will be ousted, regardless, I do believe that the company has approvable products. If approvals are gained with all the regulators I believe all will be forgiven.
Gary
That is very interesting, I had thought that they were using multiple cameras with a computer integrating what was being sent. I think that the helicopter views of the vehicle are amazing.
Gary
I think in every stock I can think of at times I've felt like investors were being treated like mushrooms. I frankly liked the marketplace as it existed years ago when spreads were far greater, and people, not computers, did most of the trading. I really liked to look through the Annual Reports back then, they were expensive publications, pleasant to read, gave a feel for where the company is, and where it's going, and wasn't a major publication on the risks of owning stocks. I'm saddened that our Govt. and the SEC insists that so much be said on the risks of owning stocks in general, and the company specifically. I feel much the same about drug commercials that spend more time with what could go wrong than the benefits of their products.
In reality, I believe we all need to realize that much of what our companies are working on has issues that are out of their control. They may know something's happening, like a peer reviewed article being accepted, but they have no idea how long it will be, or how many changes may be deemed necessary, before it can finally be published. If they wish to speak with certain regulators before making a submission, they have no control on how long that may take. The point is, if they talk, they're often proven wrong because of circumstances they can't control, so they choose not to talk.
Gary
SM,
That's what I felt, but Mike, who provided the UK site for announcing approvals made it sound like that's how the UK wants it done, and perhaps the company isn't notified until the UK update is about to occur. I really don't know and while I believe you could be right, no one else chimed in and said so. I feel quite certain that the FDA notifies the company on making a decision, and if not an approval might even discuss what needs to be done with the company in addition to the CRL, but I'm not sure of that. I suspect they might speak with the company if they're approving, but requiring a conformational trial. I believe the UK speaks with the companies as much or more than the FDA, but don't know what I think is true.
In the case of the FDA, I don't know how much has changed since the IMCL fiasco where Martha Steward and the CEO went to prison for insider trading. It was clear in that case that the FDA had corresponded about problems with the trial, but the company openly said things were going well with the FDA and achieved a partnership with BMY on that basis. I believe there is still far more discussion than we realize, but the FDA now will state if what's said about them is a misrepresentation of their position. At the time of the IMCL fiasco, the FDA was prevented from commenting on IMCL misrepresenting what they said.
We should know for certain in two months or less, it should be good times for NWBO investors.
Gary
Thanks JFR,
As I see it, LP is constantly bringing in a tiny stream of money with newly issued shares. Frankly I'm uncertain if they're ATM sales, or permitting or asking friendly investors with options to cash them in for shares. I believe she holds, or is very friendly with investors holding virtually hundreds of millions in options and it backstops her in terms of needing cash on a daily basis. We know that she's wealthy and holding substantial options, but has restriction on how quickly she can sell them.
There is no doubt in my mind that if the company had billions available they'd operate differently. DCVax-Direct would almost certainly be in trials, and other new trials would no doubt be underway to prove a tumor agnostic label. If we had that, we couldn't possibly meet the demand, but the game will totally change once the EDEN is approved.
I don't know if others estimates for manufacturing the EDEN for a few tens of thousands is true, but even if significantly off, it would still be saying that the EDEN can be manufactured for less than what the first patient to get vaccine from it will be charged. In short, if we had the approval and the manufacturer who could manufacture tens of thousands of them a month, the need for the vaccine could easily pay for all the EDEN's being made. For now, we can only strive to get it accepted for commercial production. I don't believe that money is preventing that from happening.
Clearly in the future, after approvals, NWBO will have choices to make. Do they want to grow as a company, and take on much production themselves, or stay essentially as they are, and contract for essentially all they're doing. I would suppose that even the design of new trials could be contracted out, if that's what they really want to do, but I would think they've had the time to design the trials already, with approvals and revenue coming in, and much higher stock prices, hopefully it won't be long before they can get them started.
If you're right about a new funding vehicle, that's a positive. I suspect that after one or more approvals some contracts, or partnerships, may be announced, though it may not come until we have the EDEN and perhaps a filing with the FDA or other regulators.
As I've stated, I believe we're at T-57 today, but I believe the odds are pretty close to even that by T-30 we'll have an approval. If I'm right about that, I don't know that we'll truly get a runup to approval that's near what would occur if it didn't occur until nearly day 150. If it's correct that news only comes from the UK at the beginning and middle of the month, I'm suggesting that odds are even we'll have an approval by the mid-April report, roughly 3 weeks from now. No guarantee it will happen then, but I really believe the UK knows our vaccine very well and won't hesitate to approve it well before their 150 day self imposed deadline.
I have us closing up 3 cents today. Each 15 day increment between UK announcements has roughly 10 trading days. I don't know that we could average 3 cents a day, but if we could we'd be at roughly 80 cents by Mid-April, $1.10 by May 1st, and $1.40 by mid-May when we hit the 150 day mark. I'm not suggesting this will happen, but perhaps it will be something close to this. I'm still of the belief that we should see $2 or more on approval, so unlike some stocks that go down on approval, I still strongly believe we'll move up.
Frankly I'd be fine if we only averaged 2 or even 1 cent a day from now to approval, it just makes the post approval move that much bigger. I certainly would think we'll be somewhat higher by approval, time will tell. Where we go after approval is largely in how it's perceived by the media, and how the company approaches it. I cannot remember the last time LP appeared at a Institutional or Brokerage conference, if that doesn't change post approval it may be slow growth with gradually increasing earnings and regulatory filings, but if only a week or two goes by between LP presentations, I believe we could see the movement to a major exchange by Fall, and perhaps double digit prices by the end of the year.
Gary
The problem with comparing earnings and stock listings is that earnings aren't reliant on shares outstanding. The Nasdaq looks at a $4 share price to list, and $1 to keep a listing, but you can have up to a year to get back above $1 if you do go below and are warned by the Nasdaq. The point is, it doesn't matter what the market cap is.
A company with 50 million shares outstanding needs to have a $200 million market cap, I.E. a $4 share price to be listed, whereas a company with 500 million shares outstanding needs to have a $2 billion market cap. The Nasdaq, NYSE, etc essentially are encouraging marginal companies to do reverse splits to stay listed, or for companies that want a listing to do the R/S to get the qualifying share price.
The sad part is that R/S's almost always initially result in a drop in the market cap as they're perceived as being very negative in spite of all the arguments for them. Personally I'd rather see the company take the time to build up the market cap to meet the $4 a share rather than R/Sing to get it. I believe if the company were selling for say $.60 a share, if they did a 1 for 10 which should take them to $6 they'd actually be lucky to achieve $4, so the R/S could cost investors over 1/3rd of their equity.
If the company really wants to move off the OTC, I believe the AMEX requires $1 to be listed. If a small R/S were used to achieve that, I believe that's far more tolerated than a much larger one. A move to the Nasdaq could come some time later as share price increased to $4 or higher.
From what people are saying about earnings from Core Optics, if true that they're earning double, or triple digit millions annually currently, I really believe a few quarters of reporting such earnings will result in at least over $1, and depending on the actual earnings, perhaps even over $4. I really think we need to see what we have, and what we can add with new sales, before pushing the R/S. I hope they give it time to see. Of course we're currently not discussing what the existing company could bring to the table, but we should. Having our battery technology incorporated into any major battery makers mass produced batteries could be huge, I have no idea how close we may be to such an agreement, but hopefully that's in the cards as well, and that could put us on the Nasdaq as quickly as other listing requirements could be met.
Gary
Back over 25 years ago, when I was working, we had an expression, we never get the time to do things right, we always get the time to do things over. Sadly there was some truth in that statement. It works when you can go into the field, make fixes and then revise the plan, which could have been better had more time been permitted to develop it.
It isn't true when you're making a submission for drug approval, you need to spend the time to get it right in the first place. Of course what you view as right, and how the regulators view it may be different, and you may be permitted to make changes, but clear errors need to be eliminated before a submission. When it comes to different opinions, clearly the opinion of the regulator has to be accepted as correct, even if others disagree with it.
When you go to the IRS for advice and follow it, in tax court if they disagree, it's the tax court that's correct and the fact that IRS employees said otherwise just tells everyone our laws are so complex that even the IRS doesn't fully understand them. Differences of opinions with the regulators is no different, the regulator is always right.
I hate to say it, but much the same is true of peer reviewers for a Journal, you don't get published until the peer reviewers are satisfied with the product. You can disagree with their opinion, but if you can't change it, do it their way or it won't get published.
Gary
In most companies there are limited time periods when executives can purchase on the open market because of the inside information they're privy to, it's one of the reasons they get stock options, but there are times they can buy or sell. After retirement he should be free to trade as he wishes, but frankly I'm uncertain if he must report his transactions for a certain period of time because he was a corporate officer.
We're now at T-57, based on the UK reporting approvals twice a month the next time they should report is around day T-50. While a decision from them this early is doubtful, but not impossible. By day T-35, roughly the next time they report I believe the odds are near even that we have a decision. The trading today may be an indication that investors are starting to think about approval coming.
Gary
I'd like to know more about what's happening in Germany. Are they actually using what's essentially DCVax-L that they've made themselves, like UCLA does, or is it truly something else. A friend of mine is a nephrologist and a Dr. friend of his was diagnosed with GBM and has been treated there with a vaccine made from his tumor, and he's doing very well. I really don't know more than that, he didn't know the name of the Dr. in Germany that's treating him, but whatever it is, it seems to be working.
I know it was the German's who acknowledged the benefits they were seeing with DCVax-L and insisted that all in the trial receive it when they came out of the halt. I don't know how much the changes the Germans' wanted caused the halt, but I think it was certainly a part of it. It wouldn't surprise me if they developed a way of essentially make it themselves if it wasn't available to them until it's approved.
I hadn't been aware of it being available in Germany until someone here mentioned it, but I heard about someone getting treated there just last Friday. I'm hoping it's essentially DCVax-L they're using, even if they don't call it that. If it's not approved there I'm amazed that the claim that it's free to German citizens, but if it's true it sounds like it's a great program there.
Gary
If we take your 1.5 billion shares and want to determine what's required to get $4 share price. Let's assume a reasonably best case of a P/E of 30. The market cap is share price times number of shares, so that would be $6 billion, with a P/E of 30 they'd have to be earning $200 million a year to justify a $4 price. Does this approach sound reasonable.
Of course it's possible a P/E of only 10 would be justified, then we'd need to be earning three times as much, or $600 million a year. Frankly I have no idea what Core Optics is earning, but I do believe that if they're doing reasonably well, and if someone licenses our battery technology to manufacture their batteries, it's very possible that more than $200, or even $600 million could be earned. I don't know that they're earning that today, more likely something like $20 to $60 million, which with the same P/E figures would put us at perhaps $.40, still a big improvement over today's share price.
Who would complain if after the merger we immediately had a price between $.10 and $.40 without a R/S. To me, this would be a great place to start. There are a whole lot of electric cars coming out of South Korea and we'll have great contacts there. We've already spoken with Ford, I'm sure that others are aware of our battery media as well. The question is, do we get a big payment up front for licensing the use of our technology, plus a small royalty for each vehicle produced with it, or do we go for a larger payment for each vehicle made with our medium, but little, or nothing up front. I believe that it's possible to license what we own either way. I would hope we don't grant an exclusive license to any one company, though clearly they'd pay more for it, but if the company's right, in time it could be worked into the battery of every electric vehicle, and perhaps a lot of other battery powered items like laptops and cell phones. My point is, between the two major technologies here potentially earning billions a year is very possible, it may take awhile to reach the Nasdaq, but it can be done without a R/S and in fact might come out of just one big contract.
Gary
Zadie, I believe what you're saying is true, but I also believe I heard that when it comes to biological products there are requirements that they be made in the US. If this is the case, the Sawston facility couldn't be qualified for US commercial production. That would mean that if a substantial manufacturing facility had to operate manually, a very expensive facility would have to be built either by the company, or a contractor, presumably CRL. Individual clean rooms are dramatically more expensive than large cleanrooms that can house many EDEN units. I believe the Memphis CRL facility is already able to make some DCVax-L manually, but not in numbers required to be considered for commercial production. They can probably handle many EDEN units without further expansion. Other CRL facilities are very probably well suited to taking on some EDEN units if necessary.
I don't believe that either NWBO nor CRL want to go to the expense of building manual cleanrooms so commercial operations can start a few months prior to producing with the EDEN. If I'm wrong about biological products needing to be made here, then perhaps Sawston could do the job, but I suspect very few batches of vaccine would reach our shores unless they greatly enlarge the Sawston facility. We know the company intends to prove the EDEN units in Sawston, I really don't see them building a whole lot more tiny manual production clean rooms there.
Gary
I believe it's been clear that the British are working to be faster than our FDA which sets the FDUFA date 6 months after they accept a BLA or NDA. For the UK it's 5 months which equates to 150 days. Both agencies frequently grant approvals well before the 5 or 6 month deadlines, but if they're not going to approve it's often not stated until essentially the last day. In reality, it seems like each country has their own way of doing or expressing things, but essentially they're very similar.
To me it's sad that a trial is run under the auspices' of four regulators but they can't get together and agree to approve the product, or not. Unless one or more are willing to accept the work of another NWBO must go through applying to all four regulators. After that I suspect they'll still need to ask other companies to accept it, but most will do so on the strength of the others approvals.
I would hope that testing and acceptance of the EDEN unit doesn't have to be done four times, but I don't know that to be a fact. It's a shame that we can't do something as a world. How many countries developed their own Covid 19 vaccine, I can't say if any were better than ours, but I really wonder if working together we couldn't have built a better one and done it faster.
Gary
ILT, I really have no expectations of the Judge, my expectations are based on Posner and her firm taking this on contingency. If NWBO sees nothing she sees nothing. It's not impossible that it could happen, but her record seems very strong and I like where she's coming from. Certainly the MM's aren't just going to roll over and die, but I believe if she gets past all the delays and the case is clearly going to court, she'll come away with money, and so will the company. I'm not saying it will, or won't go to trial or verdict. In many cases a settlement is made during Jury deliberation. An old attorney friend who's no longer with us had a client take a settlement against his advice during jury deliberations, the jury was about to report and would have awarded over a million more than the settlement. Of course if you take the settlement you get the money now, whereas if the jury issues a judgement it could be years if it's appealed.
In speaking with my attorney friend he indicated that the jury award is really just the beginning. In some cases the court will award more, as a juror you really never know who will receive what. I was once on a jury for wrongful death of an 8 year old, it was a civil case and we actually had an attorney on the case. The attorney agreed that a payment was due, but once the jury went above $1 million she clearly thought it was too high and didn't participate in the ultimate amount we awarded, which was over $4 million. Of course we don't know what was paid, or whether they appealed, but I'm sure the mother received something substantial, and so did her attorney, who also had a medical degree.
Gary
Mike, I've never seen anything similar to what you've shown from the UK from the FDA. I believe that good or bad they notify the company
that would make next Monday the first day we'd possibly see something. I don't expect it then, but anything is possible.
I wonder how many people in the UK know of a decision at the time it's made. I've got to believe it's a fair size committee that reviews the filing and while it's possible a single person, like Dr. Padzur here in the US, make the decision, I have a feeling the entire committee gets the word, perhaps unofficially, but with reasonable certainty. I really wonder how well they monitor the accounts of friends and relatives of all these people to be certain no one is trading on inside information.
We've all seen stocks go down after approvals, but those stocks generally are up dramatically in anticipation of it. Those stocks make new gains once substantial revenue figures come in, but often it takes a couple quarters. The same could be true here if before the UK decision is announced our share price grows dramatically, thus far it's gone the other way, but no telling where it is if approval doesn't come until nearly day 150. On the other hand, if we get approval say by day 120 with no substantial increase in share price by then, we should fly. I lost on some options when IMGN initially got Elahere approval, but went down, but clearly made money as it sold out for roughly six times that price about a year or so later.
Gary
ILT,
I would think that Posner would look at companies in comparable situations. As I see it, we're on the brink of an approval of a product with blockbuster earning potential many times over annually. At this point I believe other such companies would have market caps in the low billions, at least $2 to $4 billion, if that's a fair assessment, couldn't Posner make a case that the difference between that and the under $600 million market cap we currently have is largely caused by the MM's actions.
Frankly very few of the companies I've followed have nearly the upside potential of DCVax's, especially if we get tumor agnostic labels. That will clearly take time, but the same is true of many blockbuster products, like Keytruda, where new uses continue to be found years after it's initially approved. I believe DCVax-L's potential to be far greater than Keytruda with a tumor agnostic label, without it it's still a multi-billion dollar product in brain cancer alone.
I don't know if this is a legitimate legal argument, but that's how I'd see it. Of course if the court agreed to this argument, and let's say they nominally agreed the $2 billion would have been a fair market cap, or roughly a $1.4 billion difference from where we are, and where we should be, they should award that much for the MM's actions, but shouldn't they also add a penalty for the MM's actions, and how high might that go when you look at the wealth represented by these MM's.
Gary
Don't forget Will Rodger's advice "Buy good stock".
He went on to say if it goes up, good, if it goes down, better, buy more. Remember you already determined it was a good stock.
By the way, for those waiting for Missling to discuss the data, as I understand it the data has been submitted to a Journal for peer review. Beyond what's said in top line data statements companies don't discuss the data until it's undergone peer review by either being published in a peer reviewed Journal, or presented at a major technical conference where it's peer reviewed. If that's not yet happened, Missling is acting no differently than the CEO's of other similar companies.
It's sad, but after trials end and the data's quantified it often takes many months before it is peer reviewed. Many conferences require Abstract submissions many months before the actual conference, so while the conference may be months after the trial concluded, an abstract couldn't be submitted in time so the next appropriate conference may be the first where it can be presented. Journal peer reviews also often take many months, and no telling how many revisions, but eventually they happen. It's probably been six months of more since a preliminary submission to Nature was somehow leaked on NWBO, the article is yet to be published. The company has no control of how long these things take to happen.
Gary
The decision to run additional trials will depend on what's to be gained with them. If they're required for approval or for confirmation by the regulator, certainly. If they're required for label expansion, it will be subject for debate, especially if they believe that off label use will eventually meet all the same end users, perhaps not.
It's also possible for one regulator to approve, and another to say they want additional trials. Once sales revenue becomes available additional trials required by some regulators should be money well spent.
Gary
You may be right Tryn, but in the past a single trading halt seems normal, multiple trading halts caused by the same MM's that Posner is suing would be something the SEC really should take an interest in. I suspect the more the MM's screw with NWBO the more Posner will screw with them if it does go to a trial.
I frankly believe that whether it goes to trial or not will largely be decided by how many zeros are in the offering from the MM's. I'd also add that it wouldn't surprise me if some of the smaller MM's agreed to individual settlements to avoid what could be the outcome in court, and Posner and the company agreed to these settlements.
Frankly the winner of the election in November could even have an influence on the MM's decisions as they may believe the SEC under one President may be less vigilant than the other. At this time the SEC isn't involved, but the more attention the suit gets, the more likely that they could become involved. I suspect the company will take Posner's advice on whether or not settling with any one or all of the MM's together, of course this assumes an offer to settle.
The Chinese have an expression, "May you live in interesting times", we're certainly doing that.
Gary
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