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We're now in a period that's somewhere between 10 and 40 days of a UK decision, the fact that our share price isn't moving up dramatically has to make us think the bashers and shorts have certainly created major doubt in the investment public. Certainly it's not impossible for the UK to not make a decision in this time, they can always do so, just as the FDA often does, but I really don't believe that they intend to do so. As a long I certainly believe they will approve, but like every decision of a regulator, nothing is a guarantee until it happens.
I've had a few friends considering buying in, or buying more, they've asked my thoughts and I certainly have been clear about the fact that a decision should be forthcoming shortly, but I can't say exactly when. If you don't invest before the decision, if it's positive, the way I expect it to be, you'll have to pay far more for the shares. If I'm right, and they don't buy, I know they'll congratulate me for sticking to my guns, and some may invest at the dramatically higher price, while others fret about another missed opportunity. I believe by no later than the end of May we'll know something, but that something might be that we have a further delay. I don't believe the price goes dramatically lower on any delay that doesn't require an additional trial, which would be years of delay. Some additional information, which can be provided in months, is practically an assurance of approval after those months. While I don't believe that will happen, I believe that somewhere in the 1.7 million pages we submitted, it's all there, but of course I could be wrong. If we've not received something by the end of the full 150 day period we were targeting at, I believe the company should explain why. I don't know that they'll do anything, I'm only indicating what I think they should do. If I remember correctly, my T-number is now 41.
The MM's have apparently once again taken control at the end of the trading day, we were up a minute or so before the close, but they managed to bring us down at the end of the day. Amazing how they can do that day after day.
Gary
If you look at her other companies that recently had their approval I believe that you'll find that most have market caps at $2 billion plus. I believe that our vaccines potential is far greater than most of the others, so a market cap in the $3 to $5 billion is very possible on initial approval. It will grow as additional approvals occur and revenue grows.
I think that we agreed that today is T-41. Only 11 days it we're on there faster
Lykiri,
I don't know what Ashkan does or doesn't do, but aren't the patients also under the care of their own Drs. If so, couldn't those Drs. be adding POLY-ICLC to the treatment.
Gary
It's true that Poly-ICLC isn't approved in this application, but it has been FDA approved in another application, you'll find it here:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174192543
This should mean that Poly-ICLC can be used off label with DCVax-L or any other disease that a Dr. wants to prescribe it for with the patients agreement. Given the trial results developed at UCLA I doubt if Drs. will have much trouble getting insurance approval to use it in combination with DCVax-L in brain cancer. Other cancers will probably require more anecdotal evidence.
Gary
I'll admit to lazily picking a date that was in the middle of a range posted by someone else, if T-42 is more correct, I'm happy to go with that. I also wasn't the one to discover the earlier goal the UK indicated they'd target to, but have referred to it enough that people are crediting me for finding it. If T-42 is the correct date, but T-30 is the new target date, that would be saying we're 12 days from the targeted decision date. That too sounds great to me.
Many here were very critical of the company when they missed on making their initial filing date, than even more criticism when it was further delayed. I believe it's very possible that the reason we're not seeing RFI's now is because of the changes that were made then. I believe that NWBO has been working closely with all four regulators all along and no doubt that has resulted in substantial delay as changes made awaited the acceptance of all four regulators. If one regulator wanted a change, I don't believe they proceeded until all four agreed to whatever the change was. Clearly it takes much longer to get 4 agencies all agreeing to the same thing, but I believe the payoff will come now as approval of DCVax-L will fly through the UK, and through the others as all terms they want in place are ready as well.
It's my belief that adequate commercial production is available, it can come from either the acceptance of the EDEN or substantial expansion of manual production capability at Sawston, and perhaps elsewhere. I'm unsure that the FDA may not require production capability within the US. The company may not speak about their plans frequently, and there are some things that cannot be announced until some preceding event occurs, but they have planned well for the future, and we'll all be well rewarded as they proceed with their plan.
I'll predict that once the UK approval is announced, then the Annual Meeting will be, and then we'll get at least some of the future guidance we've been eager to hear. I would expect that once again we'll appear at the Expert's Theater at ASCO, and perhaps there is a possibility that UCLA will be presenting info on their trials that add Poly-ICLC and/or Keytruda to DCVax-L in a peer reviewed presentation. Clearly it's an early stage trial, but with approval of DCVax-L in the UK anticipated UCLA may have considered the submission of an Abstract. If not, perhaps at one of the other major conferences later in the year.
Gary
If you look at financials in the link you provided, they dao have some data, where is this coming from?
Gary
It is my belief that all four regulators know DCVax-L far better than most products they're asked to evaluate. Remember, all four agreed to a halt and changes once the trial resumed. All four agreed to change the trial goals from PFS to OS, they understand how pseudoprogression made the PFS goal meaningless. All four agreed when Germany proposed dosing all remaining in the trial, rather than having some in the control group, they abandoned the use of a control group completely, using historical information they had available for comparison.
I would also contend that all four know about the major advancements being made at UCLA, even if no data about it is being provided. I believe that as all four approve DCVax-L they'll also encourage the use of Poly-ICLC and/or Keytruda with it, even if no official action is taken to make that happen.
I frankly wish regulators would take more dynamic actions, if they don't grant approvals where they know of tremendous benefits, grant EUA's until sufficient data exists to make it an approval, and they should work with the raw data, clinicians, etc. and not require anything like 1.7 million pages to gain an approval.
Gary
I simply don't know what the next week, month, or few months may bring. If the peer reviewed Journal article came out shortly and a matter of weeks after that at least one regulator was filed with, I suspect that we'd have a very different attitude about Missling. I don't know that's happening, but I'm unsure anyone here is certain that it couldn't be. Frankly the CEO can only work to get these things done, he does almost none of it himself.
Gary
As I understand it, the 120 day goal replaces the 150 days, it's not added to it.
All these goals are simply targets the regulators are striving to. Our FDA normally shoots for 6 months in setting their PDUFA date for anything worthy of priority review, and that certainly includes all deadly diseases, like cancer. All the regulators can delay without denying, but I believe we're in a good position to get the UK decision on time, or early.
I forget who appeared to have relationships with the UK regulators, but I believed the indication that now RFI was generated in the initial review period, so I believe that we're on track for a very rapid approval.
The only approvals I've been involved with never had the sponsor say anything about discussions with the regulator from the time they filed until they received something official from the regulator. If it wasn't an approval, they announced what was being required, in some cases it was data they could get that wouldn't cause a major delay, in others it was additional trials, and substantial delay. In every case that I believed a product should be approved, it was, but in some case it was after a multi-year delay for the new trials.
Gary
Our numbers are essentially in alignment, but you should add a 120 day assessment possibility, it's real and it could happen.
I believe that our product warrants the fastest possible review period, so I choose to ignore anything over 150 days. That doesn't mean it can't take longer, but if it does it's only because the regulator requires additional information, which thus far doesn't seem to be the case.
Gary
It's my hope that we investors are like teenager's who pretty much believe their parents are dumber than dirt. By mid twenties it becomes amazing how our parents become much smarter. I think the same could be true of our assessment of the CEO, before approvals he'd dumber than dirt, but post approval we'll see him as a genius. This is nothing exclusive to AVXL, it's been much the same in most biotech's I've watched or invested in previously. Likewise, even the most successful CEO's seem to believe that things can be done faster than ever turns out to be the case. Perhaps it could be true that companies could do things faster, but they all must deal with the regulators and they tell time with a calendar, not a watch.
Gary
By my count we're at day T-45 based on 150 days, but the whole process could be shortened by 30 or more days, we could have approval any time in the next two weeks. The basher's are throwing anything against the wall they can fine, but nothing is sticking.
Of course even with UK approval they won't stop. The issues will change to the EDEN not being qualified, and the FDA never being willing to do what the UK has done. In short the bashers will bash until those who're paying them realize it's not working, or move to the long side themselves.
By this time next month we could be a very different stock, we very well might even be at a share price where we can apply with a major exchange once all requirements have been met. It's even possible that we could have new partners or contractors working to initiate new trials, etc. I don't know that it can all come together that fast, but I think it's possible if these things have been set in motion many months ago, but waiting for just one thing, the initial approval of the vaccine.
Gary
A Phase 4 can be done simpley by having all uses of the approved vaccine reported in a database. It would cover all off label use and some assessment of the outcome over time.
We're now at T-46 by my count on the 150 day scale. If the goal is substantially fewer days we're practically there. An approval next week wouldn't surprise me.
Gary
It's easy to see that they have control, all we can do is either watch and wait, or sell out. In that I like the technology they're bringing together here, I'm willing to watch and wait, and perhaps buy more if I like what I'm seeing. I mentioned EPAZ earlier today, and they too are doing some things that are apparently are also under management control. They too are working on improving batteries and drones. I believe if both companies worked together they could really produce superior products.
Gary
There are people on this board who I believe do have such information from credible sources, I believe that they know what they are talking about.
If I am right, we will know shortly.
Gary
Anything is possible, but I believe they really had intended to meet the 150 day criteria and after review have found nothing that's preventing them from meeting the faster criteria. We know that they're in charge, but the fact that no clarification has been requested gives me reason to believe our filing will come through with flying colors. I would not be surprised if we have approval next week.
Gary
Barnstormer, Fidelity hasn't taken NWBO shares for some time, but they are currently taking my holdings in AVXL. I would suspect that when we gain approval the shorts will be in a world of hurt on NWBO. They may be able to borrow shares short term, but they will be in a squeeze and forced to make margin calls in a matter of a few days. It should be very interesting.
I really believe that we'll have an answer from the UK before the end of April.
Gary
As a new investor here, and in another company CRTG, I see both companies in the midst of major changes themselves, but also see where there are synergies where these two companies should get together to make one another products even better. I certainly welcome others to take a look and see if you think I'm right.
Gary
We're at T-47 based on a 150 day approval period, but if they're trying to get it done in less time, we're roughly 2 weeks away. If as many believe that company has 4 days after they're notified, they could be notified any day. The question is, do they announce immediately, regardless of when they're notified, or do they stage it for better timing.
An old stock broker once told me that it's best to issue good news early in the business week, that way brokers have the most time to work with their clients. A week later it's no longer considered news. If you agree with this, I would think that if they got the word on Monday or Tuesday it would be released immediately. Wednesday would be questionable, and Thursday and Friday would almost certainly await a release before the bell on Monday, perhaps even Saturday or Sunday with a webcast announced to discuss the approval before the bell on Monday.
I certainly don't know what tact the company will be taking. I would hope that they've pre-planned their moves and it's just a matter of time until they execute that plan. I would hope that many things are tied to their plans, things like the Annual Meeting, discussing new trials, etc. Who knows, even one or more partnership may be pending this approval.
We really don't know if 150 days, or less is the goal, but regardless, after all this time it's not much longer. Don't let the shorts and bashers set the agenda.
Gary
I have a feeling that 5 to 20 days are as much time as we'll need. As to the posts being down, I think the longs are showing contentment with their positions, and the shorts/bashers are coming unglued. Try not answering a basher whos asking about things that have been answered many times in the past.
The question we ought to be discussing now should have to do with where the market cap should go with UK approval. Much may depend on what we're told about other future approvals, but I believe the UK alone should bring a market cap of at least a few billion.
Gary
On the 150 day format I have us at T-48. In the shortened format approval could come virtually any day in the next couple weeks. I still believe that we will average $.01 to $.03 right up to the day before we get approval.
Depending on what reaches the media when we get approval, I think that we can be in the $2 to $5 range at that point.
Gary
I tend to believe that most things we do can be simplified. I cannot believe that 1.7 million pages are required to gain approval of a drug and frankly think that if all the key people were brought together for a matter of days it could be done with almost no paperwork at all. I know this sort of thing will never happen unless something was done in the manner the Manhattan Project was done, but I've got to believe that things can be streamlined dramatically without losing integrity.
A lack of trust is largely what's behind all the documentation and red tape that turns simple things into complex ones. If key people were taking full responsibility for the actions of their companies, or agencies, trust could be restored and perhaps things could be simplified.
Gary
Sorry to hear about your ex-wife. The sad think about people like KG is that they're not all bad, or good, they do often give lots to charity, but at the same time pick companies to oppose. I wish I felt the half billion KG gave to Harvard wasn't influenced by tax benefits he'll get for doing so, but I suspect that tax benefits have a great deal to do with charitable giving.
I suspect that if there were no tax advantages to owning luxury aircraft, yachts, homes, etc. there would be far fewer of them built. I suppose it employs a lot of people, but I really believe the money can be spent more constructively elsewhere. When multi-billionaires like Warren Buffett openly state that they're paying lower tax rates than their secretaries you know it's the case. No one can blame them for using the law to their benefit, the problem is in the laws.
If it were up to me, all tax codes would be eliminated and much simpler laws, without loopholes, would replace them. To many companies earning billions annually are paying nothing, or nearly nothing.
Gary
In the US the reason that compassionate use or right to try has remained unsuccessful is largely because companies refuse to provide the proprietary information required to be paid for what they provide. I believe the money they could charge would be what it's costing the company with no profit permitted. I cannot say what was agreed to in the UK, but I suspect that the authorities insisted that any overage collected in the figures the UK authorities agreed to be paid had to be spent on expanding the capability at the facility. NWBO only received back the monies they spent to support these patients, and Advent was permitted to build additional capacity with any funds that remained from the treatment. If at the initiation of a trial the regulator and developer reached an agreement on a fair price to charge without divulging proprietary information. Profit or loss shouldn't be the prime consideration as no real profit is achievable until all the R&D costs have been recovered, as well as the actual cost to make the product, the fact that a company takes in slightly over what the actual cost of making the dose is insignificant when compares with all the developmental costs.
I believe that if going into a trial the regulators agreed that $250K would be a fair list price for treatment once approved, charging half, or even a quarter of that price for compassionate care would be something most developers would agree to, and it could be done with no proprietary information being revealed.
I have no idea about what Germany is doing, some people are saying that German citizens can be treated for free, non citizens can pay, but I'm uncertain how much. I'm frankly unsure if it's DCVax-L, or very similar to DCVax-L. If someone knows the details, I'm sure I'm not the only one who'd like to know about it.
I have us at T-49, exactly 7 weeks to day 150, 35 trading days. I believe that we'll gain an average somewhere between $.01 and $.03 for every trading day before approval. I do expect approval before day 150, but certainly don't know how far before. I'd guess our share price the day before approval is announced could be as low as $.60 and as high as $1.50 with no additional news before then.
Gary
I'll disagree, especially when every day the same basic information is posted as news on sites like I-H. I believe for the last few days the PR by the same law firm keeps cropping up here, it clearly has a negative effect. I'm not against legitimate suits, but to me the only way such a suit is legitimate is if it can be proven the company knew a product was failing, but they continued to hype it as headed for approval.
I frankly don't believe that anyone is absolutely certain of either approval, or complete failure of any of Anavex's products. I still believe that benefits are seen in RETT's and the regulators may agree that the trial protocol was flawed. The question is, could they gain an approval with a conformational trial required, or will the choice be to run another trial that can better define the benefits. In many cases the regulator determines another trial is needed, but the sponsor lacks the funding to make it happen, and the product, which might be approvable, is abandoned.
If this law firm can prove that the company intentionally mislead investors I'm fine with a suit. On the other hand if they simply take any failure to be worthy of filing a suit against is not legitimate, and if the attorney's have a history of many such filings, I wouldn't touch it with a 10 ft. pole. We have become a very litigious people and frankly it's harmful to far more than it benefits.
Gary
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