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That may be the case, but in terms of an Annual Meeting the company was supposed to have it in July 2022 and waited till the end of December. My feeling is that they want to be in a position to announcte certain thinbgs, so I think it's better to let them have it their way, but if investors want to go to court it can be forced after 13 months.
They clearly know that we are anxious, but I think we should let them choose when they are ready to speak to us.
Gary
I believe that what's said at the AM may make a difference, but it depends on what's actually said. If multiple approvals are anticipated this year, that would be a big positive, likewise approval of the EDEN unit. On the other hand, if no such guidance is given, if submission to the UK is all that's planned for the year, it will take UK approval to to really move the stock. I expect we'll be somewhere between the best and worst we anticipate will happen this year.
I would hope that any AM will be done as in recent years, people wishing to can attend live, others can participate by webcast in the formal meeting. The advantage of attending is the ability to speak with key people one on one outside of the official meeting, that's an opportunity that can't possibly be done by webcast. We'll probably be asked to send questions, but they won't be answered as questions, rather they'll be consolidated and answered by a statement from LP intended to cover them. Investors won't be completely satisfied, but we'll know much more than we know today.
Gary
Smitty,
Cramer won't speak with companies trading as low as NWBO, I don't think he'll speak about OTC's at all unless they're uplisting already. But I believe that if we got a major story on a national network we'd get a spike up, and yes it would fall, but not to anywhere near what we're currently trading for.
Dr. Liau now has a position with the company, so she ought to be able to openly speak for the company, not just the work being done at UCLA, but I'm not certain that she'd do it. LP is really the one who should be speaking at investors conferences, like the JP Morgan Healthcare Conference this week. In the few years that I've been an investor in NWBO, I can't think of any investors conference she's spoken at. Actually very few of them will probably invite the CEO of a penny stock, but some certainly will, and organizations like BIO routinely have conferences where participants pay to present, it may be worth their money to occasionally make such presentation to bolster the share price.
Of course all this will change with approvals and dramatically higher share prices, we just need to live through the time necessary to make that happen. Year's ago a NY Times article on Judah Folkman took a company, I think it was ENMD, from a dollar to over a hundred on curing mice, but they said if given 2 years he'd cure cancer. It fell almost as quickly as it arose, but now it's gone the other way, sometimes stocks fall on drug approvals until sufficient revenue is seen from sales for them to rise. Unless we go into approval at much, much higher share prices I don't think that will be the case with us. Shorts have cast so much doubt about approvals that I believe we'll fly when it happens, if we don't somehow fly before.
If Cramer ever mentions NWBO it will be because we're already a big success from where we are today. If he hasn't changed his rules, he won't discuss anything under $4, roughly seven times our current price. It very well may happen later this year, but when it does, we won't care that much about it. When we're $4 or more Institutional investment will increase dramatically, by $5 to $7 I wouldn't be surprised if 50% or more of our stock will be owned by Institutions. At that point the MM's won't be controlling the share price, the Institutions will have a big say.
Gary
Flipper,
I think DI has learned from last year's Annual Meeting. On more than one occasion he opined that it would happen in a month or so, but it didn't. I think the company had reason for waiting, but I believe he learned that until they set a date and announce it, he won't give guidance that's easily superseded. As the IR person I tend to believe he's kept out of the loop until decisions are made to avoid him giving wrongful guidance.
Last week I felt like if they had UK acceptance late in the week they should hold till Monday, as we drift lower I'm changing my mind, we need some good news, they shouldn't hold it at all. If they do intend to announce the Annual Meeting shortly after gaining acceptance of the MAA, that they could hold until the following Monday. I view the Annual Meeting as a positive event as it's the one time management gives us a hint of what's happening. I'd certainly like it more frequently, like in webcasts with each quarterly, perhaps some day that will happen. I don't know that it's mandated if we were on a major exchange, but companies I follow that are on them do it every quarter.
Gary
Mike,
I believe you've got it all wrong. You're right that DCVax-L may be used with the cancers their products are aimed at, but you're wrong about those therapeutics not being needed. If those products improve survival, along with DCVax-L, they will be approved and used. It's very possible they'll replace other products, but the point is they're putting more and better tools in the Drs. tool kits.
In some cancers we're probably curing nearly everyone who have it discovered in a reasonable timeframe, those cancers probably won't get DCVax-L, or any of these new drugs. In so many others, the current benefits are clearly not that good, DCVax-L will help, and so will some of the new drugs you're citing that are under development. Curing cancer is like solving a big puzzle, DCVax's may be one of the pieces, but many other pieces are needed to solve the puzzle.
Remember, for each additional day, week, month or year that a patient lives because of DCVax's, that's also so much longer for them to purchase products from the BP's. The BP's make far more than high priced oncology drugs, your toothpaste is probably made by one of them as well. Of course if their high price oncology drugs work with the DCVax's, they'll sell a lot more of it because the patients living longer, and the treatment is used much longer.
Sure, in time one or more of these BP's may want to purchase the company, we should all be wealthy by the time that happens, if it ever does.
Gary
I've heard that before, many people follow Cramer, I haven't for years, but I believe that unless NWBO price goes above $4, Cramer won't touch it. I follow the news far more than any financial network, but over the years I've gathered that very few, if any, discuss stocks trading on the Pinks or OTC's unless there is major news, and normally a huge move in the share price. If things have changed there, let me know.
It's painful to trickle down day after day, but I believe we'll turn around big time once acceptance of the MAA is announced and the company starts to open up about other things, hopefully holding an Annual Meeting in the not too distant future.
Gary
Frankly it's much the same at NWBO where I have a major investment, if you don't know about it, it is a company worth checking out, potentially it's vaccine, made from the tumor itself in solid cancers, may be of benefit in nearly all solid cancers. The company really only discusses long term goals in the Annual Meeting, it does all required financial reports, but little guidance is provided until things are achieved, or about to be.
Does the company do a webcast Annual Meeting and issue quarterlies in a timely way. I know things are very loose on the Pinks, NWBO is on the OTC, hardly much stricter, but slightly. The goal for both should be getting on a major exchange and if EPAZ did get a major DOD contract, it could happen almost instantly.
Before I retired many years ago I worked in engineering for the Navy, I know a little bit about DOD contracts. Their biggest problem in getting a major contract may be the fact that they're so small. If the Govt. want their equipment enough, there will be a way around the problem, but it could be rather convoluted.
As for issuing more shares, NWBO does it almost every day, it keeps the lights on. I frankly am one investor who isn't all that concerned with dilution as long as the ultimate earning potential is in billions. I believe that's possible with either of these companies, in the case of NWBO it will come with approvals of their vaccine, in the case on EPAZ it could come with one, or many, DOD contracts. I know they're doing many things unrelated to drones, I have little idea of the potential in these other areas, but I gather that if what they develop is broadly accepted, it too could become a major revenue producer.
I frankly have never been in a sub-penny stock that went to double digit dollars, but did get into one which I know was once as low as $.03 that went to over $20 before crashing back to earth. I'm sure some sub-pennies have done it, just not any I've heard of, or been in. A friend, who's into drones, that I told about the stock invested. He felt if it reached a cent he'd be out, I said why? If it reaches a cent, a nickel, dime, or dollar I suggested to him, look at it's potential at that point. If the potential still looks good, why cash out. Perhaps take some cash out, but only if you either need the money, or want to put it somewhere that you believe the potential is also as positive. You can tell, I don't trade much, not if I believe in where my money is. Some tiny investments go belly up, but others move up, and I invest more.
Look forward to learning more about this company.
Gary
I believe Dr. Liau wants the same thing, and I think both Drs. and many others see DCVax-L being part of what they believe will work to approach 100%. Of course 100% will never be achieved in all patients, worldwide it probably isn't even diagnosed in many people who die of it, but over time the goal of 100% will always be there. I'm sure there are other Drs. who feel the same about achieving cures in virtually every form of cancer, but for now, each small improvement is a step in the right direction. The reality is, the DCVax's may prove to be a step in the right direction for many cancers, in some it may be a giant step, in others a small one, but potentially in any solid cancer the patient may be better off with it than without it.
Certainly, we'll never see DCVax-L used after surgery in every cancer, or DCVax-Direct being used in every patient with inoperable cancers, but if we see it in even a small percentage of the patients with some solid cancer we'll achieve share prices that today are hard to imagine. I tend to look at everything that's approved as something in the Drs. tool kit for them to use. Not all Drs. will use the same tools for specific cancers, but I believe the longer the DCVax's are around the more they'll be used as new synergies are found for using them with different cancers. Poly-ICLC and Keytruda may, or may not, be of benefit in many other cancers, other existing therapeutics may be, and of course new tools will be added to the kit routinely.
I believe that we know that ultimately most of the new tools come from BP's, but often they're acquired, not developed there. No telling if NWBO will remain independent, or folded into a BP. What's most important is that the vaccines will be available for patients, as for investors, we can do just fine either way as long as if it comes down to a buyout, we're paid a fair price for what we're selling. If before a buyout it's established that our vaccines are truly tumor agnostic, that fair price should be in at least triple digit billions. The question is, will the company hold out that long. My disagreement with IMGN is that they're selling out too early.
Gary
I'm a new investor, but have been in others that did reverse splits, they rarely do well.
I liked what I saw about the drone, I was especially interested in the possibility of them getting a DOD contract, I believe the drone has the potential of bring used by all except Space Force, and even they might find things they'd like to do with it. Military contracts that run into the hundreds of millions or more are very common, if they like this drone, no telling how big the contract could be.
I would like to know more about what the company's doing in other areas, but I invested based on what I read about and saw in videos of the drone.
Gary
I will have to disagree, in many cases DCVax-L will be added to the existing SOC, in some cases certain existing drugs may be dropped while others are added. In general people living longer are going to buy more products from the BPs, so at least the smart ones will welcome the vaccine to the market.
Gary
Every now and then you say something that is correct, even if you don't tell the full story. In the case of trials at UCLA and elsewhere in which NWBO is not a sponsor, the company can't really say anything until the sponsor has had peer reviewed presentation of what they are doing and the results. Even what they say about their own trials is limited without peer review.
That is what professionals do. A document was seen here yesterday that was clearly labeled as not yet peer reviewed, when it has been, with whatever changes are needed and issued, then the company should be able to freely discuss it.
Gary
Good seeing you too, are you holding any IMGN still. I'm outspokenly against the buyout there and not only strongly said so, but also invested in a lot of cheap out of the money July Options. If they either get another offer, or investors, mostly Institutions, turn down the buyout, the options should be very profitable. If the buyout goes through as is, I'll probably be buying much more ANVX. My other major biotech investment is NWBO, it's due to make a big move any day as they've applied to the UK and should get acceptance announced shortly. I expect substantial positive news from them in the next couple months.
As for ANVX, I would hope that management announces that they'll be filing for approval in spite of an anomaly with the control group. In NWBO's case the control was completely removed from their Phase 3 trial by the cross over design of the trial. Patients who's parents think they're doing better because they reacted slightly to a placebo shouldn't be the judge of long term improvement, or not. I'm a believer that when you have good historical information about patients, all should receive the experimental drug, then you can really judge if patients are getting better over time. The FDA and other regulators are working on making historical data an option on many trials, while the final documentation isn't out, the FDA has written a Journal article on it and I don't believe NWBO is waiting for the final document, I believe they're waiting for approval of their EDEN unit, it automates the production of their personalized vaccine.
From what I've read, if you remove the control, RETT patients are doing better, I believe the regulators can deal with that, do an approval like they did with IMGN's Elahere, but either require an confirming trial, or even better, track all who get the drug for awhile by having a Phase 4 in which all use of the drug is reported by the physician administering it. I'm speaking of a simple input unless some problem is noted, that would require further documentation.
Gary
Yes, that's exactly what I think. If you look at Clinical Trials, I believe all the trials show UCLA as the sponsor.
I can't say if either Poly-ICLC or Keytruda is supplied for the trials at a discount, or for free, and we know that UCLA has been permitted to make the vaccine there, but all credit in Clinical Trials appears to make it UCLA sponsored, and we know that UCLA has gotten substantial NIH grants, so it's likely that the trials are at least in part using that money.
I believe the same is true of the other trials that have been cited, they're being done at a single clinical site and that site is named to sponsor the trial. In such a situation, I believe it's possible that if these trials lead to approval some tiny royalty stream may be a part of the arrangement, I really can't say. I know at City of Hope they've actually developed some of the largest selling drugs, like Herceptin, which they've licensed to BP's in return they see a small royalty stream. I'm just thinking the same may apply to clinical sites not being paid to run clinical trials, but I certainly could be wrong about that.
UCLA and Dr. Liau have been involved in the development of DCVax-L, I've got to believe that on approval they'll see a small royalty stream from its sales. As DCVax-L starts to be applied to other large trials, I'd not be surprised if UCLA remains the lead clinical site for these trials because of their knowledge of the vaccine, however, unless some trials continue in brain cancer, I'd think Drs. from other depts. would be the lead clinicians as the trials would be with patient in their area of expertise. I'm sure that Dr. Liau would work with any of them based on her experience, but ultimately if you're being treated for pancreatic cancer, you want a Dr. who's an expert in pancreatic cancer.
I believe that virtually all the lead clinicians and institutions that employ them like to be associated with clinical trials successes, they won't hesitate to present positive data at major conferences or prepare Journal articles as appropriate. UCLA may not say their vaccine is DCVax-L in such presentations, but they've made it abundantly clear that it is, with NWBO's permission.
Gary
Gary
I have no specific knowledge of what will be happening, but I believe our time has come. I believe that Nature gets us off to a good start, but the news will be almost purely DCVax-L related, beginning with the UK acceptance of the MAA filing. If I'm right, by this time next week our share price will be substantially higher.
Gary
I think we all need to realize that if others, including UCLA, are running trials with DCVax-L, whether it's made by the company, or produced by the sponsor, with NWBO's okay, it's the sponsor of the trial who'll discuss results. If as UCLA has done they specify their dendritic vaccine is DCVax-L, once results have been officially presented by the sponsor, then NWBO can discuss them. It would be different if NWBO was listed as a sponsor, or co-sponsor of the trial, but that doesn't appear to be the case in either the trial in Germany, or recently disclosed here, and it's certainly not the case in the UCLA sponsored trial. It was the case for the Phase 3 Trial for DCVax-L.
It should be noted that Merck also isn't listed as a sponsor in the trials utilizing Keytruda. I would expect as either registrational Phase 2's or Phase 3 Trials begin, all companies who's products are considered a part of the trial should be co-sponsors in such trials which ought to be done at multiple clinical sites. Given their experience I'd not be surprised to find that UCLA was the lead clinical site, and with her working relationship with NWBO, I'd be surprised if Dr. Liau was announced as the lead clinician. In fact, if the trial is aimed at one or more other solid cancers, the lead clinician could be from an entirely different department.
It's my belief that any new registrational or pivotal trial will take at least a few years to arrive at a conclusion with an exception of having the DSMB halting early for efficacy, recommending early approval, or futility, trial failure. If anecdotal evidence is strong, the trial may not be necessary for patients getting the drug, off label use will be permitted and covered by insurance if sufficient data exists to justify it. I've never seen precise figures, but it sounded like over 100 in the compassionate use program in the UK used DCVax-L for a variety of solid cancers. That's a fair amount of anecdotal evidence.
Gary
Thanks Laker's, lots of good information there.
Do you live in L.A., I've been here all my life. After winning the tournament the Laker's are falling on bad times, hopefully they'll work their way out of it. The Clipper's on the other hand are playing well.
I'm more of a football fan and the Ram's have always been a favorite. I'm thrilled with how far they've come this year. If the right Ram team shows up, I think they can beat anyone, but they have been inconsistent. We'll see what team they bring to the playoffs.
Gary
CNBC has 775+ million OS, I wonder why the disparity. Personally I don't fear over a billion shares outstanding. One of my biggest investments is NWBO, it has 1.7 billion shares authorized, and well over 1 billion outstanding. If their personalized cancer vaccine is approved for all solid tumors, and it's not bought out, the company has the potential of reaching a trillion dollar market cap, right now it's under $1 billion.
I can't say that Epazz has this sort of potential, but when I first heard of it yesterday, and read about the niche their in, I'm of the belief that they could have that sort of potential if they get a major order from the DOD, etc. I showed what got me interested to a friend who's into drones, he was amazed by their drone. I know it's just a part of their business, but it's one that looks like it could explode in the near term future.
If the Govt. or foreign allied govts. like their drone, a one million order could grow to far more if they can deliver on them. No doubt they'd need to build additional manufacturing capabilities to answer such orders. If Epazz isn't acquired by a much larger company no telling how large it could get. Much the same is true with NWBO.
Gary
I'm new here, but as I understand it they have other successful Rett trials and the negative in this trial may have been purely a judgement call not a scientific measurement that had the control perceived to be improving, the placebo effect. I don't know that the company can't file based on the combined trials, as I understand it, the patients who remained on the drug also continued to show benefits. I hate to see a product dropped on the observations of those on the placebo.
I still believe they have a shot at a conditional approval in which they can sell the drug, but also must run confirming trials.
Gary
I'm a new investor, but where do you see 3 billion shares. When I look at financials I see 500+ million, not 3 billion.
I certainly want to learn more about the company, at current prices I took a flyer on a few hundred thousand shares, if it's going somewhere I'll probably add more.
Thanks,
Gary
Nothing we say will make any difference, but what they do will. Give it another week or so and I think we'll know what is happening. That goes for the MAA as well.
Gary
Thanks, I've rarely used AI, but clearly it does explain things well, as long as the information it has is correct, it's great.
I believe that we should be getting the confirmation of validation any day now, personally I'd rather see it on a Monday or Tuesday for greatest impact.
Gary
Reg,
The EDEN unit is the unit being developed by FlaskWorks, which is wholly owned by NWBO, that's about the size of a printer and will make DCVax-L in an automated manner in a disposable cassette that will be provided by St. Gobain's Glass. In the UK they have sufficient manual manufacturing at Sawston to have that facility certified for commercial production in the UK, and perhaps elsewhere.
Ultimately once it's approved the EDEN unit should take over commercial production everywhere, but we've not had an update on the progress they're making toward that approval since the last Annual Meeting, over a year ago.
I'm still of the belief that the company wants this prior to the other regulatory submissions, or at least by the time their production facility must be inspected as part of the acceptance process. The company has not stated that, some believe Sawston is adequate with manual production for initial approval and that's certainly possible.
I do believe that nearly 99% of what was submitted to the UK will be in submissions to the other regulators, so it shouldn't be a monumental task, however the UK did approve the production facility first. The submissions to the other regulators would need to include information on the commercial production facilities, and the regulators would inspect those facilities as a part of the overall acceptance.
The UK has far more experience with DCVax-L because of its compassionate use program where patients have paid for the DCVax-L and it has been used in several other cancers besides GBM. I don't know if anyone outside the company and its contractors know if in approaching the UK they're including data from compassionate use, and other early phase trials that did use DCVax-L in other cancers in attempting to get a tumor agnostic label. Achieving such a label with a regulator would be a real game changer, but it certainly should be considered a long shot if they're trying it at all.
I really can't say when they'll hold an Annual Meeting, clearly it's late as the last one was held the end of December in 2022. That one was nearly 18 months from the prior one, but to call it a meeting for 2023 I would think they need to hold it shortly. It seems like in the OTC they're very loose with what companies are permitted to do unless shareholders take legal action to force their hand. I would rather have the company choose when to do it than force the issue, but it could be forced if shareholders take them to court as I understand it. I believe the Annual Meeting will provide guidance on when the company intends to approach the other regulators, and perhaps also when additional trials are anticipated to begin. Also it certainly should update the status of the EDEN unit.
Gary
My experience is that most companies don't announce submitting to regulators, they announce their acceptance. Far less risk in doing that as if delays occur investors are not concerned because they don't know a submission was made.
I believe that NWBO will announce acceptance because DI previously said so.
Gary
Doc Logic,
I'll have to disagree about the partnership being a mandatory. Don't get me wrong, there will very probably be other companies that co-sponsor trials with NWBO, but I don't see them taking a position in NWBO, so I'd consider that a collaboration, but not truly a partnership. I say this because I don't believe that LP will agree to a partnership in which the partner has a serious ownership position in the company at under $20 a share, and no BP's going to pay substantially more than twice the current share price.
I believe that we'll have a many things happening before we reach a share price around $10. To begin with, beyond the acceptance of our MAA, we should have an Annual Meeting soon. At the Annual Meeting, I would think we'd get an update on the status of the EDEN unit, and some sort of guidance on when the company intends to approach the other regulators. We should get some news on the planning of new trials with both DCVax's. In short we'll learn a lot about what's planned to happen in the future, then we'll get approval from the UK, and with all of that our share price should grow. Perhaps at this time we should start new trials, and there we may have co-sponsors who're paying at least some of the costs.
I believe that this would be quite a bit of news, and should certainly bring our share price to the $5 range, or more. If by that time we're filing with one or more of the other regulators it could go substantially higher, if we're using the EDEN for commercial production, higher still. In short if all this has occurred it may be very possible that our share price is in the $10 or greater range, then we could be ready for that equity partnership with a BP. It won't happen overnight, but it could be this year. Let's see what's revealed when the company holds it's Annual Meeting, we should get some idea how close we're getting to this sort of success.
Gary
When they closed the mall the first thing they did was tear down the parking structures, it's a totally different place than when it was a mall.
Gary
We pass the structure frequently, used to shop there, it had already undergone substantial change since it closed as a mall. From the artistic renderings shown on the news in LA I'm not sure if they're tearing down a lot of the new structure that's already been created when they were making it into office suites. It should be a great facility, I wonder if Dr. Liau and some of the staff will be moving there for research, while maintaining patients and surgical treatment to the hospital at UCLA. It's probably a 10 minute drive from one place to the other if traffic isn't too heavy.
So much outpatient surgery is being done in surgery centers, I wonder if that may be the case here, as long as patients can go home the same day. Many years ago, when my wife had breast cancer surgery, we went to UCLA at about 6 a.m. and were headed home by 11 a.m. I'd never guessed that it would be done so quickly, but as soon as she could walk they wanted her out.
Gary
At one time I was told that companies had something like 3 business days to issue PR's when events that rate them occur. I don't know that this remains the case. If it does, if the company was notified tomorrow or Friday of acceptance of the MAA, what would be best for the stock, an immediate issue of a PR, or holding to before the bell on Monday, when good news is most effectively issued.
Personally I believe the company is planning to announce a number of things, acceptance of the MAA, an Annual Meeting, Proxy, etc. so the question is do you do it strategically over a few weeks, or all at once. I rather like the idea of keeping NWBO's name in the news by having something positive happening early in the week for a few times a month rather than dumping them all in a single PR, even if that is possible.
I think we all know that we'll get acceptance soon, I think we know there will be an Annual Meeting announced shortly, then we'll see a Proxy, the meeting itself with a progress report on what the company has done, and plans in the immediate future. My point is that we know it will happen in time, but others, people who've never heard of NWBO don't. I believe we'd best be served by well timed releases that potentially reached many new potential investors than a single dump at the earliest possibility, even if we have to wait a couple days to get the best impact to the announcements.
I believe the DI is knowledgeable about how to do this for maximum impact, but I believe he'll do what he's told, so if it comes out Friday after the close, it would be clear to me that he's not being allowed to do things with the maximum impact. There are probably still a lot of senior people on Wall Street on vacation this week, by next week almost everyone has returned from their holiday's. I'd rather see a release before the bell Monday than something in the next two days.
Gary
Found this on AVXL I-H site, they have reason to believe their RETT's drug that missed in a trial criteria still has substantial hope, some of the reasoning is in here:
https://scholarlycommons.law.wlu.edu/cgi/viewcontent.cgi?article=4358&context=wlulr#:~:text=Under%20U.S.%20law%2C%20there%20is,new%20drug%20to%20be%20approved
I didn't get into it in depth, but clearly many things in here could apply not to just approval in GBM but toward tumor agnostic as well. I believe a much broader approval than we believe is possible, but confirming trials would be required to make it permanent and all inclusive.
I believe the document is considered current, but don't know that to be a fact.
Gary
My mistake, I saw someone say the British weren't working today because of it.
Of the major industrial nations in the world, I know that we have the fewest national holiday's. Funny, some of the days that people spend the most on, Halloween, Mothers and Fathers Day, Valentine's Day etc. get no time off work. I'm reminded of Scrooge feeling cheated for giving Xmas off.
I believe that much of the world is going to 4 day work week of either 32 or 36 hours, the US will probably be the last to do that as well. Toward the end of my career we went to a 4 day week with 10 hour days, the weekends were nice, but in Winter getting to work before sun came out and leaving after it set was really a drag during the week, especially if I didn't get out during the day.
I wish we could deal with the alien issue and realize we need substantial numbers of them. Many countries intentionally import a lot of workers, both skilled and unskilled, to deal with issues where sufficient citizens aren't available. We bury our heads and make believe we don't need them, but would complain like crazy if we couldn't buy fresh fruit and vegetables, meats, etc. because there weren't people to harvest them. Musk may create robots to replace many of them, but I'd rather have people, and 32 hour work weeks, and I believe we can still be the worlds leading economy, people employed in the leisure industry will need to grow as people will have so much more time off. What we have at the border is wrong, but if we allow more in to fill the jobs they won't need to come in illegally.
People elected to public office should put the good of the community they're serving above their party, it's not just Congress, it's govt. everywhere. Also, soliciting funds and electioneering should be illegal until a couple months before the election, and ideally funding should be public funds, but very limited, mostly supporting debates and town meetings not 24/7 commercials with essentially no error checking on validity of what's said. It may never happen, but one can dream.
Gary
Flipper, I think the question may properly be, did they do a rolling review on the MAA, make suggested changes, so at most what they may be seeing are some changes they hadn't fully reviewed, or is much that's in the MAA new to them. If in fact the rolling review has been done all along, than acceptance could come very rapidly, if not, perhaps it will take awhile, and they may even be asked to make some changes before acceptance.
I'm one who believes it's been under a rolling review, but I can't be certain of that. If we do gain acceptance in the next week, or so, I think it's because they've largely already reviewed it. If that's the case, I also think it could lead to approval in substantially less time than the 5 months they allow themselves. Today was Boxer's Day in the UK, so tomorrow would be the first day something is possible, but I'm not expecting it that fast, but anything is possible.
Gary
I'll certainly admit that I may have missed something previously, but I wonder if anyone saw that if you wanted to submit a proposal at the Annual Meeting, which will only be held if the buyout isn't approved, it had to be submitted by December 28th of last year. I'll be the first to admit I don't read that much of the financials, etc, I skim them, so I could easily have missed such notice. Did anyone remember seeing this, and is it common with other years.
The company is clearly working to get this done with the very least interference from investors. It's clear that at least a few legal firms are seeking to prevent this from happening, at least in the manner currently proposed. I have no idea if any of them have the support of one or more of the major Institutional holders, without that it no doubt will pass as they wish.
There is just over 4 weeks, but hopefully it's sufficient time to get an additional proposal, or for ABBV to up the ante to avoid a shareholder veto of the agreement.
Gary
At some point you trade in the $2 to $5 range before moving up. How long we stay in the $2 to $5 range will depend on what's happening while we're there. By the time we've filed with all four regulators, I believe we'll be above that range, and by the time we have approvals from all four $20 or more is very probable, but that will take time. For now, I think most investors would be happy to get into the $2 to $5 range in the next few months.
Gary
You can put down LP all you wish today, and some will agree with you. In six month, if we have approval in the UK and the price is $2 or more, very few will agree. When it's $5 or more, no one will agree.
No one, but shorts, like being down, but it's far better than being out. I suspect that if many others had to deal with what LP has dealt with, NWBO would be out of business, investors would get nothing, or perhaps a few cents a share in a buyout. She has positioned the company for tremendous future success, just give it time to occur.
Gary
I could be mistaken, but I believe that if a filing is rejected for changes, most companies would make the change, resubmit it, and say nothing until it was accepted. I don't know that most companies announce submission, but even if they do, when acceptance is delayed investors just assume that some changes are being made and wait to hear of an acceptance. Of course it would be very different if a complete rejection was occurring, but I believe that would be very rare if the company and regulator were working together at all during the trial.
In the case where IMCL's BLA was rejected, and Martha Stewart and the CEO were jailed for insider trading before announcing that additional trials were being required. IMCL knew of the FDA's problems with the trial, but didn't have to divulge it until the FDA officially rejected them. During that time they sold BMY on partnering Erbitux with assurances that things were well with the FDA. At that time the FDA's hands were tied, they couldn't criticize their views being improperly stated. After this case the rules were changed and if the FDA's position was misrepresented, they could say so.
If they ever wanted to make a Biotech version of the movie "The Sting" all they'd have to do is do a picture of what IMCL did to BMY in the partnership for Erbitux. Of course in the end it became a blockbuster drug, so it took longer than BMY figured, but ultimately it was very profitable.
Gary
When no money is attached to what's being called a milestone, almost anything the company wishes can be called a milestone. If there were a partnership, and if at specified points money was paid by one partner to the other, those payments would truly be defined milestones that are achieved as they're truly material events.
I believe most companies announce the acceptance of a filing for approval by regulators, but the filing, and acceptance of something like an IND to permit a trial to be started is something many companies don't announce, unless they are truly milestones in a partnership and they're receiving substantial money. Investors frequently discover new trials in the Clinical Trials database for trials that haven't been formally announced.
I believe we'll get a PR for the acceptance of the UK filing once the company is notified. It could be this week, or next. The question may be, do they also announce an Annual Meeting, or are they waiting for something more before it's announced.
I for one certainly learned how secretly discussions could be held in the recent IMGN buyout offer. Many people were speaking about a buyout at some point in the future, but none had any idea that it was coming so shortly, and for so little, so fast. The same thing can be said for partnerships.
Gary
Buyout vote scheduled for January 31st.
https://ih.advfn.com/stock-market/NASDAQ/immunogen-IMGN/stock-news/92927342/form-defm14a-definitive-proxy-statement-relating
Sorry that more financial information won't be available before the vote, but management clearly wants this to happen, so they're forcing the issue ASAP. I can only hope that Institutions tell them no.
Gary
We're essentially in the same place. I've invested more in NWBO than any other stock I've ever bought, but with the buyout IMGN is worth much more than NWBO.
Something I do believe that all of us need to do when discussing future prices, look at the Market Cap. I'd make the assumption that 1.5 billion shares are outstanding. IE a $20 share price represents a $30 billion market cap. While that may sound high, a billion in earnings could give that with a P/E of 30, certainly a possibility, or it would take $3 billions in earnings at a P/E of 10. I frankly believe that in time our earnings will go to tremendous numbers of billions, but it doesn't happen instantaneously.
If we're not bought out, and when we gain a tumor agnostic label, I've got to believe our sales will quickly go into double to triple digit billions, earnings will certainly go into double digits, for purposes of discussion let's say we reach $30 billion in earnings and lets say we're still at 1.5 billion shares. That's $2 a share, P/E or 10, $20 share price, P/E of 30, $60 share price. I believe that we'll justify that P/E of 30, but it can't be taken for granted. All that I'm suggesting is that earnings take time to grow, but our potential, with a tumor agnostic label, is almost unlimited over time, a trillion dollar market cap in a decade wouldn't be out of the question if anywhere near half of all solid tumor patients are getting one of the DCVax's. If we remain independent, just give it time. If we're bought out after a tumor agnostic label, but not that much in earnings, it ought to be at least $30 billion, or $20 a share, and it ought to be more than that.
Gary
Now up to 40K, going for 50 and plan to stop there.
Gary
I agree, in time trials covering all of this will happen, the question may be what is first.
By the way I rounded off my position today with more shares than I'd have dreamed of a year or so ago.
Gary
JT, some suggestions you've already received are certainly possibilities, I do believe it's also possible to initiate things on their own in this way. If the trials are totally new trials, those requiring filing new IND's, having the IRB and lead clinician totally formalize the trial protocol, it could take the better part of half a year to do so, IE major new funding may not be needed until later in the year, when approval in the UK occurs the share price ought to be substantially greater and revenue should be routinely increasing.
I have no idea the status of new IND's, etc. or if the company is looking to expand existing trials at UCLA, or elsewhere, transitioning them into registrational Phase 2's or even Phase 3 trials. I don't know if the company can take over, or co-sponsor existing trials which they currently have no position in.
Hopefully our share price will be substantially greater once the UK accepts our filing, that would give the company a little financial flexibility to issue a few million shares to initiate new trials. No doubt, they'll need more, but perhaps not till after UK approval and at that time they should be in a much better financial situation. I would certainly expect that others who'll benefit from their products being utilized in new trials will also participate in trial costs, but I don't know that they'll pay NWBO for the right to do so, though it's certainly a possibility.
Gary