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Our current market cap is only $570 million. With a submission to Europe in the fourth quarter of this year, by this time next year we should have an approval or be very close to it. I believe that with approval the very least our market cap should be is around $2 billion, but it could very well be $5 billion or more depending on how other things are advancing. To put it another way we should at least be four times our current price, and perhaps ten times or more. I certainly believe that if by the time we get European approval we've already also applied to the FDA and others we'll be at the higher range of what I've suggested, and perhaps substantially higher if other news is positive on other indications and perhaps even additional filings to gain approval for them.
Do others here agree with my assessment. If you do, I believe we have a great deal of upside potential before we actually file, and as we approach a decision by the regulator. I'd expect the share price will be dramatically higher than it is today. With each month or quarter, we should be moving toward that price.
Gary
That's an after-hours price, the close was at $6.74. The high for the day was $7.24 so as I understand it, if we trade below that on Monday we don't have a gap, but I'm not a technician. I've never believed that every gap must fill, but most do in time.
Gary
Dstock, it's always been clear that we're represented by some of the best in the industry. I'm sure if we examined the MM's defender's they're also very talented. The key is the judge. I believe the decision will be not to dismiss the case, but I'd be very surprised to see these highly talented attorneys go against one another in court. It certainly would be interesting to see it happen, but I just don't see the MM's opening up their books and permitting an examination of what they've been doing. I don't know if they'll ever divulge who paid what, but they cannot prevent the overall amount showing up in the financial report from NWBO, and of course Posner's firm will report a substantial gain.
It would be nice if the SEC questioned why the MM's would pay so much, but I doubt if they'll dig into it. They might if NWBO were on a major exchange, but they pretty much look at the OTC's like it's the Wild Wild West. Only the Pink's get less scrutiny from the SEC.
Gary
Karl, the only way Griffin, or anyone else, can be jailed is if the SEC or Judiciary joins our case or takes up one of their own based on what they're learning from our case. I'm guessing that little will be learned because they'll settle before disclosure. If I'm wrong, then others, like the SEC, can see what NWBO is fighting.
I suppose that if the case settles, even if confidentiality agreements are imposed, it's possible the SEC might want to take a look at what the MM's wanted to hide, but I wouldn't hold my breath in thinking this will happen.
Gary
You may be right, but I believe CRL could be a CDMO for NWBO and I believe they recognize the potential of DCVax-L and could make a deal where they're well paid for making it, but not paid to contract to do so. In fact I still believe that they'd lease the EDEN units, and pay NWBO to do so. CRL would make plenty of money as demand for DCVax-L grows, and so will NWBO.
Gary
Many years ago I played routinely, but not that well. At our club there were two elderly gentlemen, I'd guess they were near the century mark, who were fascinating to watch. They'd rally with one another, never stepping more than one step to hit a ball, and could do so for several minutes without missing. When approached by younger players they'd still not take more than one step, but their returns would land inches from the corners and they usually could reach the returns. They would run players from corner to corner, it was a beautiful thing to watch.
I haven't played in many years, but am in awe of the way they play today. Years ago in the men's game, rallies generally were very short, a good first serve won most points. Today's players make contact with practically everything, it's almost impossible to count a player out of a point. In short, the players are simply far more skilled.
Gary
I certainly hope it closes by Wednesday, but the same was true last month. If all concerned wish to go another month I doubt if they'll have much trouble in doing so. I doubt if the stock will make any substantial move either way until the merger is completed. Hopefully the news that's released once that happens will result in a big move up at that time.
Gary
I don't know where James River came from, I believe it should be Charles River Labs, CRL which is a massive company with a $12 billion market cap. I believe that they have the resources to supply most of the world with our products if we lease them the EDEN units needed to do so.
Gary
Underpar, no one seems certain, but if the UK goes by final validation, then roughly August 7th would be the 150th day, if there has been no RFI, that would be their goal date, not 210 days figuring they requested more information and the company took the maximum 60 days to deliver it. Interestingly August 7th is around the time their second quarterly should be out, it will be interesting to see what their guidance is there. It would be even more interesting if they scheduled a webcast to discuss the quarterly, not something they normally do, but something many other companies do.
I really don't care precisely how long it takes, within reason, as long as the answer is approval. I frankly wouldn't even mind if it were conditioned on further trials, as I see that happening anyway, though I hope it can be in combination with Poly-ICLC, Keytruda, etc.
I frankly wish the others took an approach similar to the FDA. I don't care how long they review prior to accepting, or rejecting an application, but once accepted, it would be good if they stated their goal for evaluating it as the FDA does with it's PDUFA dates. As is, everyone is just guessing when the 150 day, or any other goal date, begins.
Gary
If the FDA never deviated from the rules, the trial would not have proceeded with their concurrence. This, and perhaps other trials, is resulting in rule changes, many that have not been totally formalized, but exist in the FDA written journal article that will permit more trials against deadly diseases to use historical information and not require control groups. That ultimately is how DCVax-L is to be judged.
The FDA is changing, while I believe it has a long way to go, it is far better than it used to be.
Gary
During the Manhattan Project there were scientists who believed the slightest possibility existed that they'd begin a chain reaction that wouldn't stop when the A-bomb was first exploded, but they proceeded anyway and didn't end the earth.
When DCVax-L initially went into trials no one knew about pseudoprogression. When they learned of it the choice was to either end the trial right then, and design a new trial that took it into consideration, or to work with the regulators to redesign the current trial, and proceed. I'm not equating the Manhattan Project to NWBO's actions, but in both cases the decision was to proceed in spite of the risk of failure. The atom bomb almost certainly ended World War 2 faster and with fewer lives lost than if the US invaded Japan. NWBO's approval should prove to be a new paradigm in the treatment of solid cancers. In terms of overall benefits, it should actually save many more lives than would have been lost had we chosen against the atom bomb and invaded Japan.
Gary
The people at the FDA apply common sense regardless of what their written rules say. They are not going to consider approving a product where they know product won't be available for American's to use for a substantial period of time.
Gary
In roughly two weeks we should get the next quarterly report. I don't know if the company will once again make a statement about having any more information requested from them, or not. If they do, and if they say no information has been requested, I believe that by roughly day 200 they won't be requesting anything more from the company.
I still believe approval could come any day, possibly even before the quarterly, but regardless even Fall ends this year a Winter begins about December 21st. I really don't know what LG based his remarks on, perhaps he has inside information on how quickly the British are working, but it would surprise me if that's the case. I really believe the regulators work in secrecy and those assessing what they're doing are just guessing, but their guesses may be based on their knowledge of prior actions of the regulators in approving similar drugs.
Clearly the British have a 150 day goal, but only occasionally make it. The US generally takes 6 months after accepting the application and probably achieves that 80% of the time. If the US isn't going to meet the PDUFA date they generally reschedule it in advance, and they'll generally meet or exceed the newly scheduled date.
We are now at the point where if we were asked for information, and we took all 60 days to answer, we'd be at the point where they should act, if they were on time. I don't believe that happened, but at the quarterly we may get some indication.
Gary
Let's apply some common sense to this issue, the FDA isn't going to approve a product where virtually no product will be available because sufficient production capability doesn't exist where it's already been approved. Sawston in manual mode can't meet the total UK demand, how can it possibly be considered as being a production facility that American inspectors will view as meeting American commercial production.
Gary
I know you're not the only one saying this, but saying 2025 is saying the British need a year to meet a 150 day goal. I simply don't believe that will be the case. Perhaps 200 to 250 days, but not 365 plus. In this case I'm speaking from submission as they could take less than a year and do it in January from the date of initial validation.
I'll be very surprised if we don't have the approval by September, but remember fall starts by September 21st.
Gary
Doc, I think it's premature to discuss potential revenue in 2025. I believe your figure is based on only manual productions, I believe many here believe the UK will approve the EDEN this year and once approved many of them could be rapidly deployed provided they have the cleanroom space, and I believe they're in construction of the large cleanrooms, so by the end of the year the EDEN's could meet the rooms they're intended to be operated in and capacity could be a multiple of what's available with manual production.
LP is playing her cards very close to the vest. I don't know if people suggesting that the UK is already working on EDEN approval really know, or only are speculating, but I do believe it's possible.
As for the discussion of 2 to 6 months for approval based on LG's comment about Fall, remember Fall begins around September 21st, so it's less than two months. I still believe the UK will act before than, we'll see if we get any new guidance in a couple weeks when results are released for the second quarter. I frankly don't know how LG or even LP, or anyone else, can know with certainty how quickly the UK regulators will act. The regulators are well past the 150 date, if LP reinforces the fact that they've still not been asked for information I suspect the we can conclude that they won't be asked for anything more. By September we'll be at roughly 250+ days since the submission was accepted, the UK normally acts in less time than that for priority reviews, a product fighting deadly diseases would certainly get priority review.
Gary
If you know that it will be two months, you're actions may be wise, but if it's next week, next month, etc you could very well pay ten times or more for the shares if you wished to buy them back. They would still be a bargain given where the company could go in time, but I doubt if you'd buy as many as you sold if you had to pay ten, or five, or even twice what you sold them for.
I'd be very surprised if the day we gain approval the price doesn't go above $2 giving us a market cap around $3 billion. If mass media coverage is big it could go much higher as emotional buying kicks in, but the approval in the UK ought to be worth at least a $3 billion market cap.
Gary
That had always been the case between SGEN and IMGN. SGEN was higher for decades, and finally, the buyout occurred.
Rumors of a buyout never seem to end for certain stocks, and sometimes, they occur.
Gary
Too long, it's taking too long. That's a story I've heard many times in the better than a half century that I've been involved in stocks, especially biotech stocks. In IMGN the CEO said "soon" so much, and nothing happened, that investors writing about it spelled it backwards, NOOS, to emphasize it. Fortunately everything he said would happen did, but eventually might have been a better word. In some cases his soon translated to an action that took well over a year.
I actually believe LP hasn't been overly optimistic about how quickly things would happen, she doesn't speak that frequently, but when she does it seems to be an honest appraisal of what's happening. In my mind I think she would like to surprise the street with events happening quicker, but that's in my mind, it will only be the case if things go very well.
The key isn't how long it's taking, the key is how good it is. The JAMA Journal seemed to take forever, the company had no control, but wasn't it worth it in the end. Much the same can be said about so many things, they're all the building steps to tremendous success.
It's my hope that on initial success NWBO doesn't do what IMGN did, sell out. I know many would like to get paid big time, and a buyout would do that, but at what price. I really don't care how high it may be, I believe we have the potential to go far higher will be there in the not to distant future. A buyout after all regulators have approved and we're well into additional trials for both DCVax's should bring a huge price if the trials are going well. That's at least a few years off, but shouldn't investors want to know if both DCVax's have benefits in many solid cancers. What does that do to the share price. If that is in fact the case, I cannot imagine a buyout offer that isn't at a triple digit share price. I frankly doubt a BP can afford it, but if they can, fine.
Gary
While I agree with you that nothing is certain, I still think that we have a sizable short position, and while they may be trying to unwind it, volume has not been great enough to do so.
I believe that volume on the day we gain approval could go into the hundreds of millions of shares, much of it computer driven. The shorts squeeze should be a thing of beauty for the longs.
I suspect that the MM's are short and they don't have to meet calls the way investors do, and it will just be buried in the books.
Gary
DMB, I only remember the EUA being used in Covid 19, but perhaps it's been utilized elsewhere. It's my belief that when the regulator, FDA in our case in the US, sees adequate indications of efficacy and safety, even if a product is still in trial, an EUA could be issued permitting the product to be sold and covered by insurance. It wouldn't be permanent, but proof of efficacy could be added by those taking it under the EUA by including data from its use in a Phase 4 trial which is easy to input unless something unexpected is observed.
I believe all the way back when they had the halt the regulators may have seen sufficient evidence that an EUA could have been granted then. I'm not sure all the regulators would agree, but the German's pushed for all to receive the vaccine, no more placebo's, I believe they could have done it in Germany and sent everyone else a message in doing so.
If it were up to me, tiny companies like NWBO could provide promising Phase 1/2 data to the FDA and they would conduct the Phase 3, so they're observing the results themselves. In doing so the FDA would gain a small royalty on sales to pay for their costs and fund other similar trials, which may fail. The difference is with them running the trial, when they see enough they simply declare the product approved. No need to develop millions of pages, and years of such development because the people looking for benefits are running the trial. This wouldn't be mandated on all drug developers, but at the proper time they could make the choice. I believe most companies with solid Phase 1/2 data would make this choice as approval could be much shorter, and clearly cost less, but they would be paying an adequate royalty to the FDA for every sale.
Gary
Thank you Doc, you clarified what I was trying to say. I don't believe that since FlaskWorks was acquired there has ever been a plan to build virtually thousands of tiny cleanrooms, and even with those numbers they'd need more in very little time. If there were no EDEN, perhaps such a plan would have been developed, but there is an EDEN and they're putting their faith in it.
Gary
I've never heard of a product intended for a deadly disease that wasn't granted priority review by any regulator, I don't believe that's the case here. Depending on where you start from, we're in the sixth or seventh month of the five month approval process. The UK doesn't clearly define where the start is, submission, initial validation, final validation, take your pick. The UK could say they're not yet to day 150 and who can tell them they're wrong.
If they operated like the US FDA on acceptance they'd establish the equivalent of our PFUDA date, no doubt they'd call it something else. It seems that the EU, Europe, and perhaps Canada all would rather keep people guessing. They may keep the heat on the regulators in the US to meet a date, it seems more casual elsewhere, even if the goal is to do it faster than the US.
Gary
We're in agreement. In the back of my mind I remember a regulation I heard about prohibiting products made with blood products being exported or imported into the US. I may be wrong about this, or it may no longer be in effect, but if it is, you couldn't apply with commercial manufacturing in the UK.
I've always believed that the EDEN was the key to filing with the FDA. What is the good of gaining approval if you cannot deliver the product, they need more capacity than Sawston can provide manually, and I really question if it has the capacity needed with it being built out completely with EDEN's. I still believe that CRL will become our CDMO for the US, Canada, and perhaps other nations. When the EDEN is approved I think we'll learn of licenses being granted to CRL to lease EDEN units and a contract to be a CDMO for NWBO.
Gary
Gunny, while I agree with you as to our potential, but look at the size of the industry we're talking about. I don't know, but I suspect that 10% of what we could supply to the entire industry would almost certainly lead to a double digit billion, and perhaps even a triple digit billion dollar market cap. It won't happen overnight, but if by 2030 over 50% of the cars being delivered are all electric, and many more are plug-in hybrids, you can see an awful lot of batteries, even the straight gas or diesel cars may have optics from the Core Optics side of the house. No telling what other products will have tremendous sales as sales in South Korea continue to grow, and sales in the US are initiated. No telling just how high we may be at the end of this decade. When I figure market cap in a rapidly growing company, I believe a P/E 30 is fair.
Gary
You may be very right, during almost all of the trial the UK was part of the EU, so it's possible that they could even piggy-back off the UK approval, likewise Canada with it's close relationship with the UK. Production will still be the problem. I don't see building any more tiny cleanrooms, though it's possible, they're expensive to build and I expect will be near obsolete by the time they can be completed and certified.
Others clearly disagree with me on the EDEN being required for US approval, the company doesn't come flat out and say it, but if they could have gained approval without it, I believe they'd have sent a BLA to the FDA first.
Of course there could be another way to do the work manually, I doubt it would ever be tried, but UCLA makes the vaccine themselves. I would suspect that hundreds to thousands of research facilities and hospitals have the same support equipment that's utilized at UCLA. If we licensed many of these institutions to make DCVax-L and taught them how, that could lead to distributed production. I don't believe it will ever go this way as long as the EDEN unit is viable. Only a total rejection of the EDEN could result in such a solution. I don't know if making the vaccine requires some sort of secret sauce to be added to each batch, if it did, then NWBO could totally control making the vaccine in a distributed way, but if not, anyone could rip them off, but if it was detected they might pay dearly for doing so.
I've been told that there may be another way of making the vaccine manually. A device that's sealed and has it's own controlled air supplies and gloves built in to manipulate what's inside could be used. Perhaps a few such devices could be installed in each of the small cleanroom. If you could get a few of them into each room production could be doubled, tripled, etc based on how many fit in a single room. An additional benefit would be having one person able to manipulate all units in that room, and perhaps even the other rooms, as that person isn't being exposed to the contents of the device. When I was a patient at City of Hope I once was transported between buildings underground and passed rooms with such devices in them, people were manipulating what was inside through heavy gloves in transparent plastic chambers. What's unclear to me is how you initially place all the material into the room, and how you remove the vaccine when it's completed. Frankly even if you could put 3 such units in every tiny cleanroom, I doubt if Sawston would have the capacity to serve all of the UK for very long, but it would be triple what's possible today.
Gary
I know of many drugs who's approval was delayed because of problems at the commercial production site. Clearly that was with mass produced product and it required mods to the equipment producing the product, but clearly their has to be an inspection of the production facility. What facility would NWBO have inspected? I don't believe Sawston would qualify with existing manual production, it's limited capacity isn't sufficient for the UK alone, that's why they're building the large cleanrooms intended for the EDEN units. It's really not clear to me that blood products are permitted to be made elsewhere, if I'm right about that, even Sawston with EDEN's may not make compliance, but I don't know this is the case. If it is the case, we'll need US production, I suspect that CRL will become our CDMO for the US, and perhaps much of the rest of the world, but they'll do it only with the EDEN unit.
Gary
Doc, what you're saying is true. However, ask yourself this, if they never found FlaskWorks or found any other way to automate the process, I would suspect that at somewhere in the $250K to $350K per patient they'd be able to build and staff as many tiny cleanrooms as needed. It would take far more space and require far more people, but I believe it still would be very profitable in the end.
As I remember it, DNDN had planned to make Provenge manually. I don't believe the problem there was that they couldn't meet demand, I believe the problem was that at the price, they had almost no demand. There were other therapeutics deemed to be at least nearly the equal of Provenge. That will not be the case with DCVax-L, especially when it's combined with certain other therapeutics. 50% or greater survival at 5 years is a ten fold improvement on the SOC. I know, that's not what the Phase 3 shows, but we know it's what UCLA is achieving in earlier stage trials. As long as UCLA can do this with products that are already approved for other diseases, they can be used off label with DCVax-L with no further trials. Additional trials will probably be run by the developers of those drugs to expand their label, and NWBO may be paid to support those trials. Of course I don't know this, NWBO may have to pay, but I believe it's possible that they'll be paid.
Other trials, like DCVax-Direct or DCVax-L in other forms of cancer will almost certainly be paid in part, if not fully, by NWBO. Post approval revenue should permit this, though I'd suspect at higher stock prices they'll do an offering and Institutions will take every share they're willing to issue.
Gary
RD, I'm still hoping for 2025 and believe that the EDEN can be approved by the end of the first half of that year. If I'm right about that, and if NWBO is working on everything else needed to submit to all the regulators, I think it's possible for some, if not all, approvals by the end of 2025.
Of course this is all based on the EDEN unit, with over 5 months left in this year I wouldn't be surprised if it received UK approval this year. I understand that both Sawston and London have been working with the EDEN for some time, I don't know how much of this work has been done under observation by the regulators. If they have been involved, perhaps we're closer than we think, if not, we'll have to wait. I suspect that there will be a great deal of pressure on them if once approved the demand for DCVax-L is far greater than can be produced manually in the Sawston facility. I'd not be surprised if the tumors already properly preserved in anticipation of approval will overwhelm Sawston before any new patients are added. I believe that Sawston has also been providing DCVax-L for the compassionate use program, I don't know who will have the priority once the UK approves.
We're going into the eighth month of what was supposed to be a five month approval process in the UK. Clearly the answer from the UK could come any day. I can't say it's still not months away, but we know of nothing preventing it from happening now. I wrongly thought the British normally met these deadlines, but clearly they don't. Our FDA on the other hand does seem to meet its PFUDA dates most times and they leave no one guessing about what that date is, it's one thing I believe they excel in. I do believe they're improving, but there is much to be improved by all the regulators in bringing down the cost of drug development, and clinical trials. There is something dramatically wrong with 1.7 million pages in an application for anything. I know I take a simplified view of things, but to me the information in the peer reviewed JAMA article ought to be sufficient to gain approval.
Gary
The problem is that we don't yet have commercial production capabilities that the FDA would approve. I certainly could be wrong, but I don't believe that the current capabilities at Sawston would be acceptable to the FDA.
They may file when they are confident of EDEN approval in a few months, but it is more likely that they would wait until they are certain.
Gary
DD, the 10 month period noted for the FDA may be an average, but it's not an FDA target. PDUFA dates are established on submittal, products worthy of priority review get dates 6 months after acceptance, others get 12 months. Products intended of deadly or disabling disease almost certainly get priority review. The FDA does a pretty good job of meeting their PDUFA dates, but certainly does delay sometimes, and often rejects the filing and establishes what's needed to cure the problems they see in the application. Sometimes the application can be refiled in a matter of months, but often additional trials are required and no new NDA or BLA can be filed until needed trials are successfully completed.
Sadly over the decades I've seen many blockbuster drugs which obviously should have been approved delayed, often by years, because the FDA insisted on more in spite of the fact that the product was clearly of benefit. In every case which I felt that way the product was ultimately approved if the developer could afford the effort. In a very few, the failure to gain approval put the tiny biotech out of business.
Gary
I have an investment in AVXL, too. On their board, he gets more criticism than LP gets here. He's not a good speaker because of a very heavy accent, English is not his primary language. I do believe that the company will succeed, but because of their science, not because of him.
Companies on major exchanges and selling for several dollars are simply invited to many conferences, it's rare for a CEO of a penny stock to get an invite to anything of consequence until they do something that rates banner headlines. At that time, they may no longer be a penny stock.
Gary
Dmb, it may be politics, but frankly I believe the regulators are hearing from the not only the politicians, but also the public, to reduce the cost of developing drugs. I believe the streamlining the regulators are doing is a good start, but frankly they have a long way to go.
I believe that if regulators see with their own eyes that a product is clearly of benefit, with no further paperwork they should be able to issue an EMU that applies until they can review a proper filing and act, or at least for a limited number of years. Any product on an EMU should be sold at a fair price, but each use should be logged in a Phase 4 database which should establish it's efficacy. If negative side effects are seen, it can result in mods to how it's used, or it can be removed from the market. In our case, years ago an EUA would have been possible, the company would have had to build many small cleanrooms, as the EDEN was too far off, but it would still have been very profitable.
Gary
The first time it happened to me I took much of my holdings out of Fidelity and put it elsewhere where I still had margin available. The last time it happened I had very little margin, but rather than making the call, I sold some out of the money calls to eliminate the tiny amount that I'd taken. When IMGN was $5+ I'd had perhaps $50K available in margin, and used a few K, when it suddenly went to over $20 they took all margin away, even the $50K available when the stock was $5 was allowed when it was $20. I called Fidelity at that time and spoke with brokers, with their managers as well, I was assured that none of the broker who made that decision could be spoken with, the decision was made by a group that don't speak with regular investors about their actions.
I really can't say how many companies this happens with, or how often, I only had it happen with IMGN, but heard from others who'd had it happen with other companies, and with other brokerages. My point is, the brokers, like the MM's, can influence the share price with their actions. Today, if brokers who allowed investors to take naked short positions in NWBO, if those brokers acted in a coordinated way to say all shorts had to be eliminated the short squeeze would be magnificent even at these low prices, which wouldn't remain for long. I don't believe any routine investor can do a naked short, but if you're a big enough client, anything may be possible. Of course no brokerage want to destroy the relationship with their biggest customers, so they won't independently act against them. They do have rules, and if their short positions are deeply in the hole the rules force them to have their customers eliminate their short and we get a big, beautiful short squeeze.
Gary
Does it mean anything to you that Judge's he appointed couldn't find one case where he was right about being cheated in the election. Not one win in something like 60 cases, many in front of Judges he appointed. What does it take to admit he lies.
Gary
Much of what you say is true, especially if you look at the statistics through 2019, but he was President through all of 2020 and if you look at the economy at the end of his term, he was a disaster with some of the biggest deficits in history. 2024 minus 4 doesn't equal 2019 as much as the Republican's would like to say it does, look at the figures at the end of 2020.
While you're at it, look at the statistics on energy production, you'll find our production is the biggest in the world now, and we're producing the most energy we've ever produced.
Look at the facts, not what Trump says, if you want to know if he's lying, watch his lips, if they move, he is.
Gary
You may disagree, but I don't think you can prove any of my statements wrong.
As for Trump's business acumen, he went bankrupt several time, including Casino's. He ran a charity that was determined to be operating illegally. He fronted a University that was forced out of business and I believe had to refund to many students. He cheated all sorts of contractors out of what he said he'd pay. His tax returns are constantly under review as he attempts to pay nothing in spite of being a billionaire. He'd been sued by many, and lost many of the suits. He's still claiming he won the election in spite of all courts rejecting his claims, often by judges he appointed. How much more need I say to see that he's a bully who worships dictators, and would really like to be one.
Gary
Thanks ILT,
Frankly it's been many years since many who would have invested in NWBO would consider it again. I'm speaking of a large percentage of investors who won't buy penny stocks, and many in that class consider anything under $5 a penny stock. This of course also includes probably over 90% of Institutional Investors. Some investors and Institutions won't buy OTC's at any price.
I don't see Institutions buying on emotion, unless they're essentially computer traders who're buying, and selling, perhaps many times in the very same day. The Institutions that buy, and hold will come in when the price is stably trading at a few dollars or more, many not till $5 or even $7 is achieved. Many brokers won't allow margin trading on NWBO even at $5 or more instantly, but eventually it will gain that status, and some investors will use it to increase their holding as well. On more than one occasion Fidelity suddenly stopped permitting margin on IMGN after it made a major move up, this forced sales by some investors in spite of having far more equity than before the move. I don't like it when brokerages take such action, how can you say you allowed full margin when a share is $7 and no margin when the price is $20, but they do and in their own way they were holding the share price down by their actions. When brokers take such actions you can move to a different brokerage, but often they act together in this manner. I don't know if major Institutions use margin, but I suspect if they do they're not affected by the decisions of brokers the way individual investors are.
Frankly I expect that when we're stable at $5 or more and on a major exchange the company will conduct offerings priced slightly below the current trading price. The purpose is both funding the company, but also to meet a heavy demand by Institutional Investors who want to establish large positions which provide stability to the company. Even if the company doesn't need the funds at precisely that time, they'll still agree to do the offering that will go entirely to Institutional investors. Individual investors may not like this, but in the long run it's for the benefit of the company, and us investors. In time I'd also suspect they'll ask to raise the authorized shares, perhaps to as much as 3 billion shares, that would give them the flexibility to either take in an equity partner, or acquire a company, like Oncovir, for instance, in exchange for shares. Nothing like this should occur before $5 or more is seen, and we're on a major exchange, but in time I'd bet it will happen unless there is a buyout.
Gary
A win, or loss is based on approval. Precisely what day, week, month, or even year that approval occurs doesn't matter as long as it's an approval. If a company fails on one attempt, but still has other shots on goal it's only a failure if all it's shots fail. A shot can be defined almost any way you wish. Some companies have many different products in development, that's what IMGN did until first they gained approval on Kadcyla, but it's Roche's drug, but finally they gained approval on Elahere, which they developed and owned. I often put down CVM, for at least a few decades they've had one product, they keep trying that product against different targets, it keeps failing and they just turn around, select another target, and use a good search and replace program on all their prior press releases and insert their new target for the abandoned old one. Perhaps some day their cure will find it's disease and they'll have great success, meanwhile they do reverse splits and issue a lot of new shares along with PR's that are confident that this time their technology works on the newly selected disease. I will admit that I invested in it many years ago, it was called CVM even back then, but they used the symbol HIV, and of course the target back then was AIDS.
I believe our first full shot, DCVax-L, will be a winner and it won't be that long before we know it. I say full shot because I wasn't in the company at its genesis but believe they had others, like DCVax-Prostate and I'm not certain they didn't have it before DCVax-L, but it was the first they determined to take into pivotal trials, so it's their first real shot. I frankly don't know if in the future there is a place for DCVax-Prostate, of if DCVax-L and/or Direct will fill that role without a separate product being brought through trials.
I certainly believe the company will be developing, or acquiring new technology, as in their recent agreement. New products will either build on the success of the DCVax's, or perhaps improve on them, and ultimately replace them. Almost nothing is absolutely forever, but some products are good for over a century, like aspirin, while others last a decade or two before improvements lead to better versions that ultimately replace the earlier versions. A decade from now we might see improvements on the DCVax's by others, it won't matter, we'll be wealthy beyond our expectations far before then.
Gary
There is almost nothing a CEO can do to expedite what's demanded by the regulators to approve a therapeutic. In IMGN's case, the regulators could have approved Elahere years before they did, but they insisted that IMGN try the drug in a greater percentage of the patients than it was originally targeted at, when the trial proved that rather than approving the drug based on the benefits by those it was targeted at they said, there weren't enough of them, go run more trials. The did allow a smaller trials to reach an approval, but wanted a larger confirmational trial which eventually showed the same thing. By the time the confirmational trial was completed, the company had been sold for a low ball price IMHO.
In short, companies are at the mercy of the regulators, and the regulators are generally thought to favor the BP's over the tiny Biotech's. LP has done an amazing job getting the company to the brink of tremendous success. I believe we'll achieve that success well before she either sells, or retires from the company.
Gary