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I have us at T-49 today, just 7 full weeks to 150 days if the UK takes it to the end. I see all sorts of speculation on what NWBO will be paid for each patients vaccine post approval, and frankly, unless figures come from the company, and the regulators, it's meaningless speculation.
Until NWBO provides guidance on how it intends to take on worldwide commercial manufacturing, preservation, distribution and sales of the vaccine, nothing is really known.
I'm of the belief that the longer a patient to benefit from the vaccine, the more NWBO will be paid, but I could be completely wrong about that. NWBO's agreement with CDMO's could be to receive a fixed amount when the vaccine is initially made, and nothing th ereafter. My thinking is that more would be paid initially when the entire batch of vaccine is made, then a lesser amount for each dose, but again, it's just my thought on the matter. I would also speculate that if experience suggests that the more doses of the vaccine that's given the smaller the doses will get in order to stretch it out to many years. It's very possible that the benefits of the vaccine can be sustained with a dose that's a tiny fraction of the initial dose. This is purely speculation on my part, perhaps completely wrong, the point is, none of us really know.
What do we know? I believe that we know the vaccine is sustaining lives, but we can't yet say it's curative. We know that only so much vaccine can be made, and the volume made could vary with how much of the cancer you're working with in the beginning. If we have one dose remaining, can that dose be expanded on to make more? I know that some organic compounds can be duplicated, I don't know if this vaccine can be.
Give it time, we'll get answers, but only when we've received approvals and the company has determined how they intend to make the vaccine available eventually all over the world. Of course one possibility is for the company to be bought out, in that case they'd have no say on how things are to be done, and all of us should be far wealthier, but no longer speculating on what will happen.
Gary
Whether you're a short timer, or long timer, if you're not short the stock, and have a position, I believe that we're at T-50. At 50 more days we're at day 150 from when we submitted to the UK. Some newer guidance from them could have them acting a month sooner, but being conservative we'll know by mid-May. I believe that if you're long, you'll be very pleased with the results.
Could it happen sooner, absolutely, how about tomorrow, possible, the point is, we don't know, all we know is, it's getting one day closer every day.
I expect that once it happens, we'll no longer be manipulated the way we were today. Share volume will probably be ten times or more what it's been recently, and if we do nothing more it can be the ride of our lives.
Gary
Hope things work out for you, where are you being treated. At City of Hope they do a lot of experimental work on products they develop themselves, I'd suggest getting in contact with them if you want a second opinion on your treatment. They now own Cancer Centers of America but I don't know if they do as much experimental work there. Their home base is in Duarte, CA which is in the suburbs of L.A.
Have you contacted NWBO about getting involved in a trial when Direct returns to the clinic. I doubt if they'll give you much information, but perhaps they'd have something to suggest.
Gary
Smokey,
I actually believe that if you inject it into the tumor before it's been operated on, the vaccine can work it's way into the mets. Once you surgically remove the cancer the mets can't be found, so you can't inject them until they've grown large enough to find with the appropriate scanning device. My sister was thought to be cancer free for nearly a decade, then tumors the size of a rice grain showed up in many places. She was treated surgically and with chemo but eventually succumbed. I had hoped for Direct to go into trials as it may have saved her. Thing is, I believe if before her initial surgery she could have been injected with it, the mets would have died out instead of taking a decade to reach a size where they could be detected.
After surgery chemo and radiation are used in the hope of killing off all the mets, they can never be certain if they get them all. My wife had breast cancer almost 30 years ago, while I'm sure some of the treatment has improved, I still believe they still use chemo and radiation after surgery, and I don't know how much, if any, pretreatment is used to pretreat the mets. DCVax-Direct could be an ideal treatment for most solid cancers.
Gary
I agree, maybe we'll get he word tomorrow, it's about the earliest I thought was possible. Some tomorrow it will be true.
I'd love to see the bashers and shorts reaction to reading that the approval was announced before the market opened and trading has been temporarily halted on big trade imbalances. I'd not be surprised to see an open above $2 and don't believe anyone here who's long would sell any shares at that price.
Gary
JFR, in reality DNDN developed Provenge many years ago and did get it through the FDA for prostate cancer. Unfortunately it was very expensive and not that big an improvement on the SOC and they went bankrupt as I remember it. They've come back I believe but demand is small, but they should be credited with being first. Our vaccine is far more effective and while the initial approval will probably be brain cancer, the tumor agnostic will certainly be discussed and off label use will become common and covered by insurance with sufficient anecdotal evidence.
The key is still gaining acceptance of the EDEN unit. Frankly I don't know if the EDEN unit could make Provenge, but it's a possibility, if it's price were lower perhaps demand would be greater.
I really can't say that vaccine alone will be curing cancer, but in combination with other therapeutics many more cures will be achieved. We often speak of cancer like it's one disease, we know it isn't. I believe that our vaccine will be more effective than many that don't actually use the tumor to make them, but rather pick specific targets, and mass produce vaccines intended for those targets. Certainly it costs more to make each batch of vaccine for a single patient, rather than mass producing for many, but with the automation we'll be able to achieve with the EDEN, it should be the superior product and therefore sales should be greater even at a higher price. Of course I could be wrong about this, if the generic vaccines achieve the same sort of T-cell responses, they could surprise.
I just heard of someone who had a bone marrow transplant, but I really don't know if any marrow was actually transplanted. Bone marrow was truly transplanted years ago, but it was the stem cells in it that were doing the work. I had stem cells for leukemia, I doubt if any marrow was processed at all, though it's the choice of the donor, it's faster and more painful getting the stem cells out of the marrow, the other choice is spurring extra stem cells which can be harvested, like doing leukapheresis from the bloodstream. It takes longer, but has little pain involved. I was told most people do it that way. I don't know if any disease actually requires the marrow to be transplanted, and when the stem cells are transplanted they don't target them into the marrow, they just put them through the same catheter that other IV liquids come in through. It was somewhat fascinating watching my blood counts come up after the transplant, for a few days there was virtually no count, then gradually the numbers came up a little higher each day. In my case on day 19 I was allowed to go home by a substitute for my Dr. who headed the Dept, but would have held me longer. Initially I had to return twice a week, as they're very concerned about rejection, then once a week, now after nearly a decade I'm still there quarterly as I only recently came off pill chemo.
I actually hope that DCVax-Direct is eventually found to be the answer in certain cancers, without surgery. If it's proven to provide cures to people with inoperable tumors, why not use it before surgery and if the tumor dies out completely, hopefully in time the bloodstream will eventually dispose of the dead matter. I don't know that this is possible, but as I understand it one of the longest living patient from the trial of direct had pancreatic cancer and was still alive the last time the data was updated. I certainly don't know if anyone from the trial is still alive, and if they are, do they still have observable cancer, or are they deemed to be cured. It's a shame that NWBO didn't have sufficient funds to bring both products through clinical trials simultaneously. Hopefully later this year DCVax-Direct will be back in the clinic.
To me, one of the saddest things about the way we develop new drugs is the time from genesis to approval. The preclinical work can take a decade before it sees the first patient in Phase 1, then a decade or more as it moves into a pivotal trial, then years to develop a BLA or NDA and finally at least 6 months to review it. I actually took a drug where in Phase 3 they ended the trial early as they recognized it was saving life in the form of leukemia I had, that was Gleevec. Decades before I remember following it and saying it was a miracle drug for the maker as remissions were sustained as long as people took the drug. Without stem cells I'd have done that, but even after them I was kept on the third generation of Gleevec because it was still possible to come out of remission. My original oncologist actually didn't want me to get stem cells on the initial remission, as that too is risky, but I was shown reports indicating a high percentage coming out of remission and spoke with the head of hematology at UCLA about a much younger patient who they didn't think they'd get into a second remission. You must be in remission to get stem cells. I met the head people at both UCLA and City of Hope and decided on COH, but I'm sure UCLA would have been fine as well. I liked the fact that COH specialized in cancer while UCLA treats everything. I really liked the feeling at COH, I'd be willing to bet that back in the Phase 1/2 period for Gleevec it was seen to work, why shouldn't it have been discovered and approved back then. Many products can be seen to be miracles, yet nearly all must go through a couple decades in development, there should be a better way of handling this.
Gary
All the bashers seem to be getting pretty desperate today, perhaps they know the end is near. I have us at day T-51 on the 150 day target, but the UK is trying to take a full month off that, as I understand it. Fact is, an approval could come in any day, we're in the window that the UK has previously acted in.
With tomorrow being the first day of the quarter, we could have some Institutions buying in with the hope that by the end of the quarter we'll be over their minimum, if not they'll sell and the fact they had stock in NWBO won't be acknowledged at all, or at least not until we're above their minimum at the end of a quarter.
We've seen guidance from the UK that they're shooting for a month less, if that's the case we're only 3 weeks from the new target date. I really wonder how many of the 1.7 million pages actually see the light of day in the 4 months they're targeting at.
Gary
I certainly agree that combinations are the keys to a cure. I've also thought that after DCVax-Direct is approved, it might very well be used prior to surgery in order to hopefully get vaccine into the mets before removing the shrunken tumor to make DCVax-L. I know Directs intent is going after inoperable tumors, but if it's effective there, it could be effective in pretreating all operable tumors as well. In certain cases it might be found the tumor completely disappears so no operation is needed at all.
Of course all of this is speculation, it's got to advance further into trials before we'll really know how valuable Direct is in treating cancer. If they find that T-cell count goes up dramatically after it's introduced the benefit could be really dramatic. I would guess that we'll need at least 4 years to achieve approval after trials are resumed.
Gary
I know you didn't ask me, but I believe if after a couple of audited quarters have been filed if we're above $1, but well below $4 I'd prefer to see a listing on the AMEX rather than a R/S to get on the Nasdaq. On the other hand, if revenue is growing and new contracts are anticipated, I'd wait and hope that in another quarter or two they can go to the Nasdaq without a R/S.
Let's see if tomorrow leads us to an announcement that the merger is completed, if so we'll have the entire second quarter in the merged configuration, that's a positive in my mind. If it occurs, and the price isn't up dramatically, I will probably increase my position.
Gary
I've always thought 100 was a good goal, but really the key is living an enjoyable life. At our yacht club there are many who've gone beyond 100, some have great lives, other just live. Some much younger people are far worse off, Alzheimer's, Parkinson's, etc. they do as well as they can, it often takes far more out of their significant other than it does them. The wife in a couple we've known for probably nearly 50 years remembers things we did decades ago, but she doesn't remember she saw me 5 minutes before when I went to the bathroom. Her husband doults after her and she really has no idea how much he does for her. They have a beautiful 70 ft. fishing machine, but she now fears going to sea in it though she used to love it.
My wife is going through a similar situation with her brother who's now having both mental and medical problems. He's given her his power of attorney, but he's calling all sorts of Drs. and trying to find the fountain of youth. It's sad and it's driving my wife up the walls. He's staying in a convalescent home that's blocks from his own home, if he could walk and go up stairs he could return there and have daily assistance, which he has anyway, but it's hard to say if he'll ever return there. Fortunately he's got insurance that will cover him for many years. It's sad, but he often calls my wife to call the home he's living at to get assistance in changing his clothes because he's soiled himself and they've not gotten to him yet. At times he wakes up at 3 a.m. and calls, my wife patiently tells him to go back to sleep, but of course it destroys our sleep. I've had enough problems that she's helped with, but I try not to demand anything, her brother has all sorts of demands. She's starting to realize she can't meet them all, and can't possibly try to do it.
Gary
I'd be 93 then, I really wouldn't mind if we're slowing our rate of growth if NWBO is still around then, and so am I. Even if we only had 10 years of exclusivity, I suspect that anyone with a reasonable investment in NWBO who hangs on to it will be wealthy. I have more than a reasonable investment, but I think many have much more than me.
Out of curiosity, does anyone think that even if more tumor may be surgically removed the vaccine may be more effective if more of the tumor is left in the patient, as long as sufficient tumor is taken to make al the vaccine they'd want to make. I know it sounds crazy, but if the tumor becomes the host for additional T-cells perhaps more of it in the patient might work better.
Many years ago IMGN's first drugs were not humanized conjugate of ricin, it was a large molecule and patients were becoming resistant to it in one or two doses. The company would never consider working for it's approval, but when refractory patients were given the IMGN drug and became refractory to it, they were no longer refractory to the SOC products they'd been on, often for years. I certainly don't know, but it's possible patients could be kept alive indefinitely by using the SOC until they're refractory, then a dose or two of the Oncolysin, IMGN's drug. There were definitely people in that trial whose lives were extended substantially, but IMGN developed what they believed to be far superior tech. It took perhaps another decade of more before Kadcyla was approved, but rather than wait for their revenue to increase from royalties on growing sales, they monetized it so others earned the revenue as it became a blockbuster drug. Finally they developed Rayaldee which they wholly owned and on success, sold the company. Frankly it made me sick though it was reasonably profitable. ABBV estimated it would be bringing in earnings of $2 billion a year, they stole the company for just over $31 a share. it should have been $40 to $50, or more. Plus they have other drug in their pipeline whos early stage trial data looks good. If I could have taken ABBV shares I'd have done it, but it wasn't an option.
Gary
Where we are today is based on what we represent today, while we've been manipulated down dramatically by the MM's etc. until our technology has the respect garnered by approvals a few billions is as much as should be anticipated. Once we have approval, then extending the lives of out patents is huge as that's the time we'll be able to supply the vaccine exclusively.
The end of patents certainly won't end the sales, but it will allow competition, if someone wants to jump into the mix. We'll have the advantage of many EDEN units, and if they too are off patents they could be copied, but anyone wishing to compete would have substantial costs. If we want to keep them out of the business, we're positioned to be cost competitive, it's doubtful they can make the vaccine for less than we can. While our profit per patient may be lower, the numbers may be so great that we simply may not be growing as fast, but we'll still be growing.
How long has Aspirin been off patent. In spite of much higher prices, I suspect Bayer is probably still making more from aspirin sales today than any other time in their history.
I wouldn't mind competing at all if we're the ones supplying personalized vaccines for patients with all types of solid cancers. It will be the investment of a lifetime if the company isn't bought out, and still a great investment if it is.
Gary
Any thoughts on Moderna wanting to partner, or acquire, us. They paid for both the article and video to be created, I wonder how much influence they had on those preparing both.
Of course neither was digging deeply into what we're doing, or how the EDEN would simplify production of vaccines really made from the patient, but at least it brings some attention to what's being done. Approval in the UK will bring a whole lot more.
Gary
Thanks Fluteman,
While this doesn't name us, it's showing what we do. It's only a part of something larger, but sponsored by Moderna, I don't believe it's the Nature publication many here are expecting that covers DCVax-L in greater depth. I still believe that what we do will be more specific to any cancer we make the personalized vaccine for, but Moderna is sitting on billions to attempt to prove their technology before NWBO can prove theirs in a variety of solid cancers beyond the brain. Ours should work better, but theirs could be approved faster with the funds they can put into it.
Gary
I'm on Hydrocodone-ibuprofen and probably should have taken more of it, as it's gotten more painful. I really don't think it's doing very much. I can take it every 4 hours, but waited for 9 hours, so I need to take it somewhat faster.
Whether I'm on meds or not, I tend to play Devil's Advocate, I don't mind criticism if some of it sounds stupid if it creates discussion that I, and perhaps others, can learn from. If it's ignored, no harm done.
I frankly have no idea whether shorts or bashers are really working for others, or are actually short themselves, perhaps both. I believe that some longs get so frustrated with companies that they post like shorts, but actually will invest more if the stock is down. When IMGN was bought out, many of the longs there for decades were unhappy about the price, in spite of the fact that we all had nice profits. There is a big difference between having a nice profit and a really big profit. At roughly $3 in NWBO I'll have a percentage profit that's the equal of what I made in IMGN over many decades. I believe I'll see that or more before the end of the year, and it will be in a tiny fraction of the time I was in IMGN. I frankly wouldn't get out of NWBO at $3, or $30 for that matter, if I believed the potential is still great, IE it's still a really Good Company. That's not to say I'll take no money out, but would prefer to do that by writing covered calls, rather than selling stock. Once we're on a major exchange I feel reasonably certain that Options will be made in NWBO, and selling options on say 10,000 shares, a tiny percent of my portfolio, can bring in enough to take a nice vacation, etc. I paid for most of my solar system and heat pump with selling IMGN out of the money calls, most closed worthless, but I did give up a few share. I also bought more NWBO with it and converted all the IMGN in our Roth IRA's to it, and right now the gain is less than had I stayed in IMGN, but that could change dramatically in just days or weeks if we're right about UK action.
I know I'm wordy, some like it, others don't. Feel free to ignore what you don't like. At my age and retirement status I have little else to do.
Gary
I'm listening to at least the beginning of the presentation, but doubt I'll listen to the entire 3 hour presentation. The one thing I found very interesting is that with all T-cells coming from the Thymus, and capacity normally diminishing with age, what is it that our vaccine is doing that suddenly increases T-cell levels in the tumor. Is the Thymus producing dramatically more, which sounds like a big positive, or are the T-cells normally found in the body somehow being concentrated in the tumor, another positive when it comes to curing cancer, but not as big as if the Thymus is suddenly greatly increasing its production. Over time T-cells are needed throughout the body, so we need to not diminish them too much everywhere else.
I don't know if Dr. Bosch, or anyone else who discovered the dramatically higher T-cell counts in the tumor have determined if they're there because of dramatically increased production in the Thymus. If this is the case, and if making DCVax-Direct can cause the same reaction, even if not injected into a cancer, say into fatty tissue, if T-cell production increased, it truly could be beneficial in many diseases beyond solid cancers, and perhaps in blood borne cancers as well. I know CAR-T, or modified T-cells have been used at City of Hope for many years, I met a patient who received his own T-cells modified with a disabled HIV virus 3 days after I had my stem cell transplant. He actually got his own stem cells the day I received mine, then the modified T-cells 3 days later. When I happened to meet him, about 2 months after the transplant, he was coming in every couple weeks, while I was coming in twice a week. The reason was he received his own cells, while mine were from a donor, in his case, rejection wasn't a problem. I still have dermatological issues as a minor problem caused by the DNA difference even though I had a 12 point match, which is as good as it gets.
As you all know, I'm not an expert in the medical feel, I'm purely looking at this as a layman, but I'm curious what others here may think, or if you actually know that our vaccine is spurring T-cell production in the Thymus of people of all ages that the vaccine is being given to.
Gary
I still like Will Rodger's advice on purchasing stock, it's as simple as such advice could be. "Buy good stock."
He went on to say that if the stock went up, good, but if the stock went down, better, buy more. Many people in NWBO have been in the company for over a decade, they made the decision that it's a good stock, and while they paid far more in the past, I believe that most of them have brought their average price under $1, and many are even profitable today.
Personally I've only been in a few years, on Thursday at the open I was up overall, by the close I was down a bit, that's not of concern to me. I have more shares than I ever believed I would when I first invested, on many occasions I've said I didn't anticipate buying more, but as the share price weakened, I wanted more, and I got it. Remember, I decided it was a good stock before I bought my first shares.
I suspect that Monday I could be up to break even again, or more, but that's of little meaning. I'm hoping the stock remains independent and in 20 years or less my kids will inherit many millions each from NWBO alone. I believe they'd get a new tax basis unless the laws change, but regardless, they should be set for life. I would hope that some of my other investment do well, but I doubt if any have the total potential that NWBO does, if it isn't bought out.
Clearly the bashers here don't believe it's a good stock, at least not yet. It's not too late to change your mind. If the long investors are right, it's a good stock, you'll either be losing a lot yourself, or the people paying you to be negative will. Now is probably as good a time as there has ever been to go from short to long.
Gary
I should add, always looking for ideas, feel free to make suggestions.
Gary
If NWBO does what I expect it to in the next month, or perhaps less, and gets UK approval for its personalize vaccine for brain cancer, which should be tumor agnostic in time, I'll be in a very concentrated position there. I won't sell, so it will become even more concentrated unless this or a few other companies I'm in make even bigger gains. I had the same situation in IMGN until it was bought out. I still have a lot of dry powder that I'm looking to invest more conservatively, perhaps in real estate on Starker exchanges on property I have in Lake Tahoe.
Gary
Does anyone think that there is a possibility that Canada would say a UK approval is good enough for them. There are still substantial ties between the two countries. I haven't been there since Charles became King, but when I was there while Elizabeth was Queen from everything you saw it was as if she was their Queen. If anyone will accept the UK approval, I think it would be Canada, but time will tell, perhaps others in the EU may be interested as well. I know the FDA will insist on approving a BLA that's developed purely for them.
Gary
I agree that the potential is there by growing revenue. I just hope that they're not impatient and try doing it with one or more reverse splits. I also think that there should be no embarrassment if they worked first on reaching $1 and going on the AMEX, then building to over $4 and moving to the Nasdaq. Once we get financials for a quarter or two, especially if we gain some battery contracts in that time, the share price could easily reach the $1+ range. Let's hope that on Monday the merger is considered as happening so the second quarter will be a complete quarter for the company including all parts of the company. I would expect a PR would be issued if this happens, but it could actually have filings made that day, but not announced until everything was accepted, if that's not already the case.
I was just reading about anticipated changes in the 2025 Mustang Mach e, which I seriously am considering. They're still not clear if they're upgrading the battery, which I had been told the were to the one that's faster charging, and can routinely be charged to 100% without damage, because of the ferric compound added to the battery. I know that'll have the Tesla plug and have Tesla chargers authorized for charging, but I really want the faster charging battery. I might even choose not to take the extended range battery if the standard battery has the better technology, which I believe it has today. I really liked the Genesis GV70 electric, but the front plug won't work in my garage because of an overhanging shelf, and I also want something with hands free capability on the highways. Most cars will have it in time, but right now it's Tesla, Ford, and GM products to my knowledge. I know the others have adaptive cruise control, but it's not the same.
It would be great if by the time I'm buying the investment I've made here would more than pay for it, at $1 a share without a R/S it would a few times over.
Gary
Flipper, I wish we could simply ignore the data from the Phase 3 trial and realize what will be achieved once Drs. understand what can be achieved by adding Poly-ICLC and/or Keytruda. The improvement to 50% or more living 5 years of longer is undeniable, and I can't believe the regulators aren't completely aware of it as well.
I really don't believe that insurance companies will fight to not add these treatments as off label when evidence of the benefits are clear. That shouldn't require much more than what UCLA has already done, and perhaps some anecdotal data from the UK and Germany. I really don't know if Dr. Ashkan will ever put together a summary of all patients treated under compassionate use, all the different kinds of cancer, and what other therapeutics were added, but if he does, I believe it would be quite a presentation. I've seen posters thinking perhaps 1000 patients have been treated this way, but have no idea how true that is. I do believe that many cancers, beyond brain cancers, have been added to the collection of cancers that have been treated, the tumor agnostic label shouldn't be that hard to achieve if the data's as good as we think.
Gary
It never fails to amaze me how much of the old and disproven garbage can be dredged up, and how longs get pulled into denying something that was proven wrong many years ago again. I don't know how many times I've seen the story on the progression failure, which is completely explained by patients on the vaccine doing better, but having progression called because they had pseudoprogression, but that couldn't be differentiated.
If people must answer these people, why not just say, disproven 2015, or whatever year you believe that was the case.
This should all be over in a few weeks with UK approval, that's all it takes to make all their claims disappear, but of course they'll say the FDA won't follow the UK, give it time, and qualify the EDEN and they most certainly will. We're at T-52 if it's a 150 day count, but T-12 if they're targeting for 120 days.
Gary
If the Endurion technology becomes incorporated in most batteries, including the solid state units, the company will be huge if it isn't bought out.
Gary
Again thanks all.
It's been awhile, but last data I saw on Phase 3 Oncology products had over 70 percent approvals. Someone might want to see if that is still about right.
I obviously have some pain where they went in, but not in my legs, as long as that continues it will be great.
Gary
I mentioned Silky Sullivan in an earlier post, if you've never seen him race, I'm sure somewhere on U-Tube he can be found. Look him up and see the similarity with how NWBO is running the race.
Gary
Thanks for all the wishes, while surgery started late, all seems to have gone well, didn't get home until after 8 but it's a pleasure not having leg pain, the pain from where they did the surgery will of course be with me awhile, but that's why they invented pain pills.
For all the Christians, have a very Happy Easter.
I now have us at T-52, I truly believe that once we're at 50 or less the approval could come on any day.
Gary
I view us more like a horse named Silky Sullivan, he routinely went from the back of the pack to win. Most exciting races I have ever seen.
Gary
PS. Still waiting to be taken in to the surgical suite.
HL,
I agree with you about not knowing the direction management will take. The last thing the FDA and SEC want to see is hype, but a properly designed PR campaign can easily be done without appearing to hype what the company has developed. I hope they approach it that way.
I'm off to back surgery, more later.
Gary
Believe me Angelo, I'm thrilled with the possibilities in solid cancers, even brain cancer alone would make this a great investment. I'm just curious about how some people believe the technology can work with other diseases. I do believe other diseases can benefit from personalized products, and perhaps the EDEN unit can do it, but that's not what NWBO's all about. Cancer is what they're after.
Gary
This is a pay me now or pay me later situation, if the longs are right. Now, before UK approval you can pay in the $.50 cent range, after UK approval it's possible the decimal point could move a place to the right if the media coverage of this new paradigm in cancer treatment receives the right sort of publicity. If the shorts are right, hard to say if the company survives to do more trials.
Note the early phase trials at UCLA, recognize that with Poly-ICLC and/or Keytruda they're achieving 50% survival at 5 years or beyond, but only when they're combined with DCVax-L. If additional trials were ever needed this would totally blow away anything happening in GBM, the regulators can read all about it from the Phase 1, IMHO it would be malpractice not to treat a patient with this off label, but if the regulators want to be deaf, dumb and blind they can ignore it and demand additional trials before an approval.
Gary
I think the question in many of our minds is, when the market opens on Monday, will the merger have occurred.
I believe it's possible, but certainly don't know that it's a fact. It would be nice to start the quarter with the merger completed and operating the entire quarter in the format of the new organization. I don't know how much will be revealed if it occurs, but hopefully we'll not have to wait for the quarterlies to learn everything pertinent.
Gary
I picked up more shares back then too, today I rounded up to a nice number to work with.
Gary
I believe all Institutions have charters that indicate where they're supposed to invest. I believe that some aren't restricted by the exchange, but are restricted on price. Few can invest below $4 or $5, but there are OTC stocks at those prices. There are probably a few Institutions who can invest now, but very few. Meanwhile, Institutions buying at or after the first of a quarter, and selling out before the end of a quarter routinely invest in companies that have nothing to do with their charter.
The best scenario for say a biotech charter that's not supposed to invest below $5 would be investing in a company like NWBO in the beginning of a quarter, and having the company exceed the $5 level during the quarter, they could book a major gain and keep the stock in their portfolio. That's the only way it would be seen there.
If they ever wanted to change things they could, electronically every Institutional buy or sale could appear, but by law they don't, and when they do have to report it's half way through the quarter following the one they were reporting on. If in the next quarter NWBO went above say $5 and had substantial Institutional buyers who kept it into the third quarter, it would be mid-August before we knew it.
Gary
I too picked up some shares today. I don't know precisely when the approval will come, or what price we'll be at the close the day before, but I believe that when approval is announced we'll see the Mother of all Gaps, and it's a gap that never will be filled. If the share price doesn't improve dramatically between now and approval I certainly believe the gap could be to a market cap in the $2 to $3 billion range, perhaps even higher if substantial media attention surrounds the approval announcement.
Today it was pointed out to me that when a company receives news from the FDA they must release it within 4 days. I don't know if identically the same applies to the UK, but if it does, the question is, do you release immediately, or do you work with major media outlets to plan a release on a given day with stories flooding the press and the airways with information about the new paradigm for treating cancer. I frankly don't know if such a major PR campaign can be engineered in this way, but if it can be, I think it would be worth doing. If it were done, a gap that takes the market cap over $5 billion is very possible, and the share price by the end of the day could be close to $10 or possibly more.
Is a market cap over $10 billion justified on approval for the UK? Probably not based on UK revenue immediately, but undervalued if based on it's potential as a new paradigm in the treatment of many solid cancers. I have seen cures for mice take a company from $1 to over $100, but of course it came back down to earth and didn't ultimately work in people. I believe that the DCVax's will work in people because it's made from the people it's being used in. It won't necessarily be curative itself, but it will make existing, and new treatments work better, for some, that will be a cure, for others, a longer life. Perhaps as or more important, at least to some, it will add no negative side effects, and may be able to eliminate certain treatments that have some of the worst side effects. It will take years, perhaps even decades to learn all the best ways to use it. We all should know that aspirin has been around for over a century and they still find new uses rather routinely.
There are people suggesting that other diseases can be benefitted with NWBO's personalizing technology. I frankly don't know how. Sure, without a tumor it would be possible to make DCVax-Direct with leukapheresis, but what do you inject it into. As I understand Direct, it's effective because it's creating the vaccine when injected into the tumor. Where do you put it to fight other diseases, or blood borne cancers for that matter. I believe much can be done with personalized medicines, I just don't know that it can be done in the same manner in the EDEN unit.
Gary
JFR, I agree, in fact if there were any Institutions who didn't belong in NWBO today's the day they had to be out, Monday's when they can get back in. I expect we may get more than normal Institutional buying Monday because the stock has till June 30th to meet the Institutional requirements, or they'll sell again by that date.
Frankly I don't know why Institutions don't use market cap rather than stock price to determine what they can, or can't invest in, but the same thing can be said about exchange listing. A company with 25 million shares outstanding and a share price of $4 can get on the Nasdaq, with a market cap of $100 million, and stay on it with a $1 share price and market cap of $25 million while a company with nearly a billion dollar market cap, but over a billion shares outstanding can't get on, or stay on an exchange. In the case of NWBO, they'll probably need a market cap over $5 billion to get a $4 share price required to list on the Nasdaq unless they're permitted to relist at a lower price, as they were on the Nasdaq before.
The exchanges by operating this way are encouraging reverse splits, whether they're intending to, or not, and it's rare that market cap is maintained through a reverse split. I much prefer the company not doing the reverse split as long as eventually, with approvals, they should easily be able to list on a major exchange without it.
Gary
Thanks TTsr,
Monday figured to be day T-50 with the 150 day path, while I believed that approval would probably come by day T-30, IE in a little over 20 days, now it's starting to look like only 10 days. I don't know if my number is correct, or we're truly at T-50 today, so a 4 day difference from what I was thinking. Regardless, if the new shorter period is to apply, approval should come no later than April 10th if they meet the schedule in the UK.
It seems like the shorts are possibly making their last stand with today's trading, the bashers have spent years trying to persuade the investment public that DCVax-L cannot possibly be approved anywhere. If substantial gains aren't forthcoming in the next 10 days, we'll truly get explosive growth on approval.
I keep saying I don't intend to buy more, but I'll almost certainly buy again before the close.
Gary
Thanks to all for their best wishes, I feel confident that the surgery will have big benefits. At 81 you have to expect some aches and pains, but I didn't want to live with what I've been experiencing for many months over the rest of my life.
Last week I purchased at $.47, so at $.60 we were up $.13, retrenching such a gain by 30 to 50% is quite common and I believe we're positioned to move higher next week. Monday is T-50 and should be the day the UK releases the last couple weeks approvals, while I doubt we're on the list, anything is possible. I've still not heard from anyone certain about whether the company will be informed of approval when it occurs, or only when the bi-monthly list is revealed and furthermore, if they are informed, can they release the information, or must they hold for the official UK release.
For all of the Christian faith, have a Happy Easter.
Gary
Today is T-54, with tomorrow being a holiday we certainly shouldn't have any news before Monday, T-50. Even if we are down a bit today, it's been a good week.
On a personal note I am having minor back surgery tomorrow and hopefully will eliminate the pain I have when standing and walking.
Gary
Bob,
As a new investor I know very little compared to the rest of you, my numbers came mostly from reading others posts, but I believe they make sense. If once quarterly earnings are in and the share price reflects the financials I'd be thrilled to be starting in the $.50 cent range. The way the business is being described, it could grow very rapidly. DOD contracts take time and a ton of paperwork, but they can be very lucrative.
I originally invested for the battery technology, it still sounds like it could be a huge winner, but I had the impression that if ordered the material could be delivered and would work with little or no modification in most battery manufacturing. Now it doesn't sound that close, but perhaps that's more because of lack of funds, not the technology. If that's the case, I'd hope that with interest from one or more car/battery makers it won't be that long before it's being used in many electric cars.
I believe between these two different, but related technologies, with just a few new contracts that Nasdaq listing could be in place without an R/S at all.
Gary