Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I'm certainly no expert, but if you go for Complete MA, isn't it still very possible that the regulators will approve with conditions anyway. The only way I would think you'd go for Conditional is if going in the only way you think you can gain approval is by offering conditions you'll meet on the regulator granting such approval. I.E. if you know you have to run additional trials, concede it up front.
In the case of many products, new trials will be needed post approval for label expansion. I see no reason not to say that if it's already acknowledged to be the case.
Gary
You may be very right that someone else would have done better, however if in time he gets the job done, he'll still be credited with the success of the company. He had been at IMGN before, and probably reacts like nearly all IMGN's CEO's have acted. I was there for decades not because I liked the management, I didn't, but because I believed in the technology. I opposed the buyout, but clearly management had the Institutions behind them and sold out at the first opportunity to do so and make a nice gain. I profited nicely, but still believe it should have been worth substantially more if they waited longer to establish a revenue stream for Elahere.
My point is that in most successful biotech's there are times when management is put down terribly, but if approvals are gained they're toasted as heros. NWBO is my biggest holding, it's heavily bashed and is going after the MM's for spoofing. Many put down the CEO, but frankly I believe that many others would have thrown in the towel long ago, so I very much support her. I believe we'll see UK approval in the next two months, the other regulators including the FDA by next year at the latest. It's worth looking at, it's vaccine which is personally made from the patients tumor will be shown to be tumor agnostic in time, if it's not acquired no telling how far it can go.
Gary
I certainly don't know, but I believe that with the recent weakness in the price the shorts are working their way out of their short positions.
As long as the substantial bashing continues I think it's clear that a substantial naked short position still exists, and if as suggested it was ever near 2 billion shares it cannot be eliminated very quickly, but nonetheless I suspect that they're working their way out of it. If most the bashers go away, I think we can assume the position has largely been cleared.
If we gain UK approval, and bashing continues, while I don't believe it can be very effective, they'll be struggling to clear their short positions at what clearly will be much higher stock prices. Griffith and others are not fools, but if Posner is capable of determining that they're closing a major naked short position it should strengthen her position in the spoofing trial. It should also work to get the SEC looking at the actions of the MM's.
Over short periods it's completely legal for MM's to have naked short positions as they're supposed to balance demand and supply and may do so under the guise of maintaining this balance. To my knowledge they're supposed to work their way out of such positions, but there seems to be no consequences for them not doing so. Many years ago a company I was invested in went on a Russell index. After hours the day they went on the exchange millions of shares traded as Institution who had to have shares of companies on that Russell index loaded up with shares at the market closing price. Simultaneously a multi-million short position was established, that's legal, but I really don't believe what happened thereafter was, that short position never was significantly diminished, it remained for a couple years when the company came off the Russell, then it disappeared. I don't know if one, or many MM's had maintained that short position for years, but clearly it was a naked short and effectively they'd created hundreds of millions of dollars worth of stock that they company didn't see a penny from. I cannot say how much better the company may have done had this not occurred, but it clearly was happening and the SEC or others never took an interest.
Let's hope that Posner is able to put this all together and in time the SEC takes an interest, but not until after she settles the case for NWBO as the last thing I'd want is the SEC delaying Posner's actions.
Gary
Doc, I don't believe that pseudoprogression was an issue with those on the SOC, I believe it was purely for those who got the vaccine who were thought to being progressing, but who actually were getting better, IE pseudoprogressing. Those on the SOC who never crossed over were simply too sick or passed on before they had the opportunity.
This scenario creates K-M curves which show patients on the vaccine progressing before those on the SOC do, but it's because their pseudoprogression was called progression and that call was never reversed, even though the patient continued to improve, and may in fact be living today. It's rather like a totally incorrect call in a sport activity, once the call is made it becomes official no matter how wrong it is.
I'm frankly uncertain today if a new trial were established whether progression would be a legitimate goal because they now have an acceptable way of differentiating between progression and pseudoprogression during the trial. I don't know if some sort of intrusive activity, like multiple needle biopsies of the tumor, would be considered acceptable for differentiating between progression and pseudoprogression. If some sort of scan cannot make this determination, I believe the only goal may be overall survival, which is the gold standard, but clearly takes longer, and costs more.
By the way, by my count we're at T-59 for UK approval.
Gary
I still believe that we should have a position in Zena based on our holdings in EPAZ,. Does anyone disagree?
Gary
I understand what you are saying, but the great CEOs are the ones who like Missling took on a fledgeling biotech and took it to success. Are you really certain that Missling can't do the same.
Every biotech I have ever invested in had the same complaints about management, but in time they either got better and gained approval, or theey were replaced or went out of business.
If they get the regulatory filing in they'll be potentially closing in on success, I think it's worth waiting for.
Gary
I've seen little of Oregon, but I'd hazard to guess that Newport, Oregon is a beautiful place, buy not a harbor like Newport Beach in CA. I gather there are few harbors until you reach Washington, but some great salmon fishing in the streams that run to the ocean.
Gary
On the subject of Coretec, I believe we need to see a quarter or two in the new organization before we really know how this is going to work out. I'm considering purchasing more, but haven't made up my mind. I welcome others thoughs.
Gary
I agree with you completely on plastics, you can practically walk on the plastics that have accumulated in the gyre areas of the ocean.
We live near Marina del Rey and I've been in charge of our yacht club's cruise to Newport Beach for years, do you live near Newport. Sounds like we have a lot in common. I've helped with cleanup in the marina too.
I suspect that microplastics have contributed to the rise in cancer and other diseases, what's really needed is something that digests it harmlessly, but I don't think that currently exists. Personally I've had 3 notable cancers in my over 80 years, leukemia with stem cells was the most serious a decade ago. I don't know if anything is due to plastics, but it's clear that it can't be good for any living thing. It's sad that we have politicians who fight cleaning up the man-made pollution that's adding to our health and climate woes.
Gary
If they removed sufficient cancer and properly preserved it they could make DCVax-L. The way the announcement was made it sounded like they failed to find the cancer during the extensive surgery, and if you believe it, it was after she was released from the hospital 2 weeks later that cancer was found. If that's true, I would think their was very little cancer in what was removed, but frankly it doesn't sound like what they're announcing really happened that way.
I doubt very much that they would use DCVax-L even if they had sufficient material properly preserved unless it previously had been successfully tried in the compassionate use work that's been done in the UK on at least a couple patients with the same form of cancer. Of course we don't have an accounting of what has been done in compassionate use, but Dr. Ashkan and others no doubt do.
The fact that the King and Princess are both being treated for cancer ought to bring added attention to work being done in cancer there. I doubt it will accelerate the approval of DCVax-L, which could come in the next 60 days, but when it's approved it may get more attention. JMHO.
Gary
The UK target for completion of the trial is approximately 60 days. I believe that it is now possible to gain approval any day and conshisider this to be T - 60.
Gary
I believe that the latest guidance not only permits you to go to Phase 3, if the protocol is essentially unchanged those in the Phase 2 trial becomes part of the data for Phase 3.
Gary
John, I'm for anything that helps to clean up the planet, but I believe the place we can make the biggest difference in is being ignored, the oceans. I've only had a basic oceanography course, but in it one thing was clear, something like 80% of our oceans have virtually no life, and therefore no photosynthesis at the surface because all the nutrients are down 400 feet and no upwelling is occurring. I believe that simple artificial upwelling units could bring nutrients to the surface and sunlight could do all the rest. Besides plankton, turning CO2 into carbon and oxygen, it would be easy to also set up kelp forests, and then establish fish farming in these areas with plentiful nutrients, plankton and kelp. In some ways it would also tend to counter global warming as colder water below would be cooling the warmer water at the surface.
Someone more knowledgeable than me needs to look at this, but it really doesn't require much energy to pump water from 400 ft. or deeper to the surface, I really think something like the duct off dryers, but over 400 ft, long could do the job. A small compressor could send air down to an airstone perhaps 25 or so feet down and just keep the water coming like in an aquarium, I just don't know how large an area the nutrients would spread out to, but believe it could be substantial. It would take many artificial upwellers, but they could be solar powered but if I'm right our oceans could deal with many of our climate problems and be generating a lot of food as well.
Gary
Based on the FDA guidance in a Journal article they authored, no control will be needed in further such trials.
I believe in the next few years you'll see most, if not all new trials against terminal and vary serious diseases use historical data to establish a base to be improved on with all patients getting the experimental treatment.
Gary
I believe you could be right, but it can't happen until after at least UK approval. I believe the share price would need to be at least in the $3 range and would suspect that we'd need to authorize more shares at an Annual or Special Meeting in order to gain the authority to do such a buyout or merger. Oncovir, as a privately owned company, wouldn't need to gain any shareholder approval, but I believe NWBO would, but it ought to be a sure thing if they have to put it to a vote.
The key, as always, is approval and developing a revenue stream, the ownership of Oncovir would build that revenue stream faster, and if thoughts of a buyout come true, it would be at a dramatically higher price.
Gary
If this is completely correct, approval could come on virtually any day over the next few months. I believe that others have shown that some UK approvals have come in as little as 3 months so we're now officially in that window. Could you imagine what would happen to shorts if virtually any market day the company announced UK approval. I'm uncertain if they would announce mid day, or before the bell after they know, but regardless, I believe based on current share price trading would be halted based on an imbalance in orders and when trading resumed the price would be more than a double, perhaps even 4 to 5 times the current price when it opens.
Perhaps this wouldn't have happened if the share price wasn't manipulated so low, but the reality is, it was, and now anyone still short the stock is in for a rude awakening. The short squeeze itself will send the share price higher than without it, but such prices won't be sustained unless other positive news comes on the back of UK approval, and that certainly is possible.
I believe that as soon as approval is announced the company will announce either a webcast to discuss it, or schedule an Annual Meeting, which I believe they must allow at least a couple weeks, they might very well do both. It's possible a webcast is announced with the announcement of an approval and trading could be halted until after the webcast if it were scheduled before or shortly after the market open.
Personally I'd love to see an announcement after the close, as someone living on the West coast I rarely awaken at the open. I'd like to be awake and listening in on the day approval is announced. Of course it would also be a thrill to wake up to say a price of $2 or more a few hours into the market day, I'll take it either way. I believe after the company is notified, be it good or bad news, they have some discretion on how they announce it within some limited number of hours. I would hope that the company already has a plan of action for how they'll keep NWBO in the news after approval has been announced.
Gary
Thanks John,
At the time I would think it was all about the company without Core Optics, it should get even better now, but of course the investors at that time only will own 20% of the company. I really believe if the battery technology is utilized by many battery makers, that side of the house could be worth more than the Optics side in time, but right not it's the Optics that are bringing cash into the company.
I'm intending to purchase the 2025 Mustang Mach E because it will have the improved battery and Tesla plug, as well as styling changes and other improvements from what I've read. I doubt the coretec media could be included in the battery, but would be thrilled if it were. I suspect it will be the 2026 or 27 model years before some of the biggest improvements in battery tech will be available on the market, and it will continue to get better. The question in my mind is whether they offer a car with 600 to 1000 mile range routinely, that keeps battery weight heavy, or look to lighten the cars, maintain ranges of 400 to 500 miles with charging to 80% in 5 to 10 minutes. I frankly think if I could rely on 400 miles and a 10 minute charge as long as most places like rest stops and fast food restaurants had high speed chargers.
I believe that all the automakers will profit nicely while converting from gas to electric power, but service requirements will be far lower and that will hurt dealerships, most like Tesla may give up on traditional dealerships. For most drivers the batteries will effectively be lifetime batteries.
I've never leased a car myself, but if the Govt. still offers a $7000 discount if you lease, but not if you purchase an electric, I'll lease than buy it out of the lease, perhaps after just a month or so. This is an incentive that should be changed, but a friend just leased a Mach E to get the $7000 discount on the price, not available if they purchased. I'm very much a senior, so I'm thinking my next car will be my last new car, but who knows, maybe leasing and getting newer whistles and bells 3 years later might be a nice way to go if money's of no concern.
Gary
Thanks for your earlier research on share count, but I really believe all that any of us can do is either go along for the ride, or sell. Of course we can also choose to add, frankly I continue to think about that.
The good news, from your analysis, is that the company doesn't need to take dramatic actions to deal with what's been agreed to in the terms of the merger. With currently authorized shares if they wished, even a small R/S say 2 for 3, would bring the total above what's needed. It can easily also be done with a small increase in the authorized shares.
I believe the real question is, how much do they need in earnings to justify a major exchange listing with say 1.7 billion shares outstanding. If we look at a P/E of 10, we'd need to be making $170 million annually, at 30 it's roughly $57 million for a $1 share price. $1 could move us to the AMEX exchange, but if we want the Nasdaq or NYSE it's 4 times that, or more. Is it possible, most definitely, but we really need to know what Core Optics is contributing, and sell one of the major carmakers/battery manufacturers to go for our battery media.
I don't know what others thoughts on our battery media's potential is, but I believe it offers billion dollar earning potential in time. How quickly can that happen, if we can make product available, very quickly.
This only is saying that IMHO it's possible to move the company to a major exchange without a R/S if the business is there to be making hundreds of millions annually. If that's not possible, and a major exchange listing is demanded, then a R/S is most likely the vehicle for getting there quickly. The key is convincing the investment public that it's the right move so the company isn't punished for doing so.
Gary
Thanks Margin Buu,
Many of the posts about Mr. Sarma make it sound like he's got major influence in biotech in India. Other than the fact that he came from there, I don't see it in what's publicly available about him. No doubt he has contacts in India, which certainly could be a good thing, but unless nothing is public about it, he doesn't appear to have relationships with BP's or biotech's in India.
Clearly he's quite wealthy, owners of sports franchises are in a unique club of their own.
Gary
Everywhere you look T-cells keep cropping up with benefits, whether it's CAR-T or modified T cells it's big news. Of course there has been some problems as well, like curing one cancer, but apparently initiating others. The administration of CAR-T can be dangerous as well, a patient I met hit 107 before they brought his fever down.
We may not get precisely the same reaction as CAR-T, but CAR-T is short lived and does have negative side effects. We on the other had generate substantially more of the patients T-cells and that increase is sustained. We really need more data to know this is happening with all the different solid cancers we treat. I'm no expert, but I believe your own T-cells in greater numbers can't help but fight all diseases in your system, not just the cancer specifically. Many cancer patients don't die of the cancer, with their weakened systems they often die of pneumonia. I'd suspect that the greater T-cell population would work to fight off that pneumonia.
I've often said that our vaccine is not a monotherapy that will cure cancer, or any other diseases for that matter, but I believe it's one that will prove to be one of the treatments that leads toward a cure. We know in GBM the addition of Poly-ICLC and/or Keytruda make it far more effective, but neither are effective without DCVax-L. There may be others that should be added, or that could be more effective than these two, the point is, you only know by trying.
I believe that very few experts would argue that increasing the output of your own T-cells isn't a good thing. If it's proven that we're doing that in many forms of solid cancers no telling how far our success may go.
Gary
I note that this is your first post on NWBO, and only your second post in years, but I'll hope that you know what you're talking about, and will be more active in the future. I was wondering if with over a decade of ownership our new board member had ever posted here, I hope you're correct that he has, even if not too recently.
I took advantage of the share price and got another 10K this morning. I certainly don't know how low we may go before we turn around, but I don't think it's much further. When we do, I'd not be surprised to see our price double or more in a matter of days, perhaps even one day on the right news.
Gary
I certainly don't know, but believe that they're trying to make everything happen by March 31st so the next quarter begins with the merger complete and will offer a clean view of the company when quarterly results come in for the 2nd quarter, late July or early August. I tend to believe that it's likely we'll have a R/S, but hope it's just a small one, in the 1 for 2, 3, 4, or 5 range, if they can keep it at that level and take us to a major exchange in time, we'll have done exceptionally well. I'm hoping that their target for such a move is by the end of the year, that gives them the time to grow the earnings to justify that price.
Gary
I've recently seen NWBO doing much the same thing. I believe that they've worked closely with the 4 regulators involved with their Phase 3 trial, but in choosing the UK to go after first they were choosing the regulator most likely to approve the quickest. They're a much smaller company than Anavex, and they've used contractors to do much of the work. I would suspect that it's the case here as well, and likewise they're going to the first regulator they believe will get the fastest approval in each indication.
I think it's a positive that it's the FDA they're speaking with on RETT's, far from a guarantee, but an indication that they believe it's possible. The FDA isn't about to tell them that if they submit, it will be approved, but they may encourage them to submit so that they can review it in greater depth. If they suggest doing further trials they're essentially saying that a submission would certainly fail. It's very possible that after reviewing an NDA they'll ask for further trials, but it's also possible that they'll conditionally approve, with confirming trials required while they're being paid, and of course it's possible they approve with no conditions. The question is what they're told by the FDA.
Many years ago IMCL, the developer of Erbitux, was telling the world that all was well with their Phase 3 Trial with the FDA, while the FDA was telling them of shortcomings in the trial. It resulted in a $3 billion partnership with BMY before they announced the FDA had rejected their filing and insisted on further data. This is the case that put their CEO and Martha Stewart in jail for insider trading, but ultimately Erbitux was approved. It changed the laws so the FDA could speak out if their position is being misrepresented. Generally few companies say little about what they're being told by regulators. I believe the others pretty much follow the FDA so you don't want to risk saying something, and having a regulator correct what you're saying. Better to say nothing until you can say something official, like our product was approved.
Gary
You'll see her when she is ready, but not a day before.
Gary
They still have to get EDEN approved, but that appears to be just a matter of time.
Gary
With worldwide cryogenic shipping possible in a matter of days, it would be possible to operate from a single site. On the other hand, with the EDEN Unit it would be possible to operate from thousands of sites that already have cryogenic and other required capabilities. It is really up to the company as to how they choose to operate.
Gary
I've only been an investor for a few months, so I don't know all the history. I think that you were also an investor in IMGN, where Missling worked in a different capacity. I get the same sort of feeling here, a management that's moving slowly and cautiously, but can bring it together in time. IMGN took a lot longer than I thought it would, and sold too soon IMHO, but people who stayed in made money.
I don't really believe that RETT's is a lost cause, but AD may be first. I'm fine with any disease, any regulator first, once that happens I believe the others will fall into place. I believe that certain trials are truly difficult to judge, and RETT's in children is one of them, especially if it's the parents judging. We all want to see improvement, and it's easy to misjudge a placebo as being effective. As I understand it, improvement clearly showed in the patient group, and continues to today, but it's up to the company to convince the regulators that it's the case. I still think it's possible.
The FDA in certain critical trials is in the process of dropping control groups and permitting all to receive the experimental treatment, they've produced a Journal article about it, but haven't fully implemented it yet. I believe if all were taking the drug a benefit would be clear. I'm frankly uncertain if this trial could be done without a control, but I would propose it if I were designing the trial. I would do the same with AD. Such an approach makes recruitment easier, as all know they'll be receiving the experimental product.
I don't believe Missling is making all the decisions, he's being advised by others, but ultimately it's his responsibility. Everyone may never be thrilled with him, but with some approvals under his belt we'll all be happy with him. The question may be, does he want to keep the company independent, or like IMGN develop some success and sell out the company. I didn't like IMGN doing it so quickly after success, but I don't mind the idea once the revenue stream is developed.
Gary
The competency of the CEO can grow tremendously with the submission and approval of one or more products by one or more regulators. It really doesn't matter which one, an approval will suddenly make him a genius. I don't know when it will happen, but if you stay invested long enough it's likely that you'll be toasting management instead of condemning it.
Gary
I've read what others have been saying, my mistake, it should have been 80% not 90% and also my own experience in similar purchases of corporate shells. While I believe that the current company should be worth more than that, I believe they wanted this to happen and agreed to such an arrangement in order to gain the financial support needed to bring the overall company to a position where a listing on a major exchange is possible.
Let's say they do a 1 for 10 reverse split, giving existing shareholders 1/10th the stock we currently hold, they maintain the OS slightly below the current O/S by taking the 80% position. With their financing and revenue if we're a $5 stock, we'd be well ahead, i.e. like $.50 a current share. Everyone wins in such a scenario.
I'm not saying it will happen this way, just one possible scenario. Perhaps they'll be no R/S, but without it, they'd really need to bring in tremendous revenue and financial backing to justify the $4 or higher price needed to go on the Nasdaq. I really can't say that they could be worth that much.
Gary
If Core Optics is a privately owned company, no one owns stock, they may own percentages.
My belief is that when all the dust settles we'll find that Core Optics is holding about 90% of the stock in Coretec and while all our shares are now only 10% of the company, the could be worth far more than they are today because it has become a profitable enterprise and is on strong financial footing. In time it may be proven that Coretec's current technology is worth half or more of the company, once they have contracts to use the technology in new batteries, we'll still be ahead as it's very possible it would have never happened without the financial backing from the Core Optics merger.
I doubled my position when the Core Optics merger was announced, and the bottom fell out of the stock price, the only question is, should I get more.
Gary
I'll be the first to admit that I've never created an NDA, BLA, MAA, etc but I think we should all understand how difficult, and massive, these documents are. In NWBO's recent UK submission it consisted of 1.7 million pages, and they already had the commercial production facility approved. I don't know that AVXL's would be that big, but even it it's 1 million, it's a massive effort. Companies take years in building such documents, but rarely discuss them, beyond long range guidance like, we're planning to submit in 4th quarter, etc.
My point is that all this is happening unseen, it very well may be discussed with regulators and determined that major revisions should be made to meet what they're suggesting. The point is, when a submission is made, the company will have achieved a major goal. I doubt if we'll be told we're weeks, or months away from a submission, but when it's done, it will be huge news.
Gary
Doc, while it's true what you're saying about the cross over design making the trial tougher to interpret, I believe that if new trials were started today, all patients would be treated with the vaccine from the beginning. Trial results would be compared with historical data. The question in my mind is whether the regulators will accept the historical data at the time a trial, which may take a decade or longer to run, is what's available at the time the trial begins, or wait to gather the historical data essentially when the trial is concluding. I would suspect that while some goals might be established at the beginning, at the end the regulators would consider how treatment had evolved during the trial and the final goals could be adjusted to reflect it.
I've always been a believer in giving the Drs. as many tools as possible, so if a product is doing good for some percentage of the patient population, and not causing harm, it ought to gain approval. The regulators often don't see it this way. You really never know how great a new product may be until it's approved, until that time a specific protocol has been used, and it can only be judged by how it did in that protocol. After approval Drs. can use it as they choose and may find much more effective ways of using it. Certainly in our case UCLA has found the addition of Poly-ICLC and/or Keytruda make a huge difference, but what if those trials had never been run. I suspect that DCVax-L would still have been approved, but the benefit of the addition of other products would take much longer, but in time it would have happened. It may take years, but in time it may be found that other products do even better than those we know of today, but the key is they need the vaccine to be effective.
Gary
Sadly what you say is true, nothing will be said, nor should it be. Other companies would treat it no differently, however, I suspect some other companies would have moved more positively on the submission of the MAA. I can't say why we didn't, but suspect it revolves around the belief spurred by all the bashers, that management simply can't get the job done. When they're proven wrong, by gaining the UK approval, NWBO will fly.
There is little the company can do until the UK acts, but when they act this should become a very different company. Both LP and Dr. Liau should receive tremendous credit and be in high demand for speaking at the appropriate conferences, LP at Institutional and Brokerage conferences, Dr. Liau and others at technical conferences.
Today, I've got to guess that less than 1% of the investment community has heard of NWBO, after UK approval I suspect that number will go to 50% and growing routinely. Certainly not all who hear about NWBO will immediately, some investors simply won't buy a stock selling for less than $5 or $10 or more, they'll be in once we meet that criteria. If the news of approval breaks well, with major media coverage, it won't be long before we're looking at $5, $10, or more, and if the stock moves on emotion, no telling how high the peak may be.
Of course the bashing won't end, the same people saying we'll never get an approval will be saying, you'll never get it from the FDA. Time will tell, but with success in the UK, and acceptance of the EDEN unit, I feel quite certain the company will prove them just as wrong. It's been said that great leaders have done nothing at a time when nothing needed to be done. LP may be found to be such a leader, she didn't attempt to hype what was being done, she just got it done, once done, her efforts will speak for themselves.
Gary
Can anyone point out where even one company reported a positive outcome at this step. I don't believe that it's normally done.
NWBO is the least likely company to do a PR that typically isn't done by others.
The bottom line of filing with the UK is approval, anything less is disappointing, even if it's just a minor delay. I believe we're headed for approval, but I really don't think we'll hear anything about it until it actually happens. Late March is certainly the earliest possibility, but anytime after that is possible. May puts us at the 150 day point, if no delays have been encountered it should happen by then. Once again, I don't believe most companies report minor delays as long as they've been resolved, so an approval after May is certainly a possibility. It's also possible that some delay occurs, but the approval still comes in 150 days or less.
I frankly don't know what other news we could get between now and approval, but there are certainly possibilities. We could get positive news on Posner's suit, or positive news on the EDEN unit moving toward acceptance. We know that Nature is peer reviewing an article that's positive, it could come out at any time. There no doubt are many technical presentations in between now and then, any of them may add to what's known about our vaccine in trials. The point is, good news can come from many places, but the really big news will be coming out of the UK.
Gary
I don't believe that any company has reported such news in the past, so I doubt that NWBO will do so.
Gary
Barnstormer, I agree. You've probably heard the story of the young attorney who's life was taken to early. When he approached the pearly gates he said, why me, so young, the answer came back, what do you mean, based on billable hours you're 118 years old.
I really wish we could not be so litigious and just do what's right, but that won't happen. I've know people who looked for opportunities to sue and didn't care if it was a friend or neighbor they were suing, a little water on the floor was all they needed for a nice slip and fall. Insurance companies know what they're doing, but it's cheaper to them to pay a nuisance claim then challenge them in court. Of course they think nothing about increasing your insurance as you had a claim against you.
We had a friend who fell and was badly injured on a dinghy dock. His insurance company threatened not to cover if he didn't sue, which he did, accusing other boaters tying up with shaking the dock and causing his fall. Another friend touched another car in a parking lot, by the time it was all over the person who's car was just touched filed a medical claim, and my friends insurance was cancelled after decades of insurance without a claim.
Gary
I really don't know all the ways a decision can be delayed, I'm certainly no expert at this. Previously some posters indicated it Posner's position was accepted by the Judge it would lead to discovery, if that's not the case we'll all wait longer. Stalling judgement seems to have become a major legal strategy. I suppose in some ways it's like going for drug approvals, years after all have been impressed with trial results all sorts of products are still working on submissions to the regulators. Frankly both areas need streamlining, but I suppose that would require eliminating a lot of red tape and violate traditions that have been practiced for centuries.
If it were up to me, at least in drug approvals, at the end of a trial the regulators could sit down with the DSMB and clinicians, if they like what they see and discuss, they could make an instantaneous decision to approve. That would eliminate the need for million page applications and save years of time, and millions of dollars being spent. I'm certainly not speaking about just our trial, I'm thinking of almost every product I felt certain would be approved, and ultimately was. If with no medical background I could be that certain, I can't believe the regulators, clinicians, and DSMB couldn't come to the same conclusion without years of additional efforts.
I suspect the same can be said of the Judge in our legal case, he may not know precisely, but I suspect that if all the key players got together it could be resolved far faster, but that's not how things are done, so they'll play with all the means of delaying a decision.
Gary
Do you really believe that the regulators are deaf, dumb, and blind? I believe they all know what's been happening at UCLA and elsewhere and know that the addition of Poly-ICLC and/or Keytruda can take long term survival to 50% or more. They may not officially be able to take this in consideration, but they do know 13% survival at 5 years is far better than 5% so approval is easily justifiable. I will admit, in the past I've seen the regulators be deaf, dumb, and blind with certain products and demand further trials on products whose approval should have been sure things, and after the additional trials, all were approved. I believe the regulators have improved to the point that today they'd have approved those products, but either asked for a confirming trial, or a Phase 4 to be run with all receiving the product. I believe our worse case will be an approval accompanied by confirmatory trials.
I suspect the company is going after the UK approval first for a number of reasons. Perhaps the biggest is the UK experience with the vaccine in compassionate use, officially they may know nothing, but they know. Secondly they've received approval for manually making the vaccine in a commercial application in Sawston, so approval is possible before acceptance of the EDEN unit. I frankly don't know if the other regulators will accept the Sawston facility as is for approval, but once the EDEN unit is accepted I believe it will happen fairly quickly.
Gary
I actually can't make that comparison, I believe that DCVax-L has the potential of being one of the highest selling products, especially if it gains the tumor agnostic label. I frankly have no idea how much has been earned with my meds, but some like Gleevec, were blockbusters, and may still be. I happen to have great insurance, my out of pocket for all authorized drugs is close to nothing regardless of the list price. I have no idea how much the insurers pay, but I doubt if it's near the list price for most products.
I hate to say it, but it probably will be true that insurers will make deals to lower what they pay for the DCVax's regardless of what the list price is. Regardless, our DCVax's will be blockbusters many times over.
Gary
I believe that the current Govt. has it right about climate change and the need to dramatically cut pollution. I've gone to solar in my house and will have the system feed an electric car when I get it, eliminating the need for batteries in the system. I don't drive that much unless I'm taking a trip, so an electric car will provide backup power to the house in the event of an outage and power overnight.
If it were up to me, all new construction would maximize solar generation, it would raise construction costs, but would pay back the buyer in little time and be profitable beyond that. More importantly, it would lessen the need for power generation and eliminate substantial pollution.
Gary