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Pqr, I know LP's an attorney, and a very well qualified one, but I believe this is largely Posner's fight and her strategy. I suppose that each MTD exposes more of her evidence, but she isn't going to quit answering their challenges. I'm still of the belief that this will settle before a jury ever has a chance to act. I expect it before they go to trial, but even if they get into it, I suspect an acceptable offer will come in prior to jury actions.
While on jury duty in the past I've met other jurors who were starting deliberations when released from jury duty on settlement. An attorney friend client took a nice sized settlement against my friends advise only to learn from the jurors that they were looking at number that were a significant multiple of what was offered, well into the millions. Of course there is the bird in the hands argument, if you don't take a good offer a bigger judgement may be appealed and no telling where you'll be in the end, or how long it will take.
I've been on juries that awarded millions for wrongful death, but as a juror you really never know what is actually paid, or by who.
Gary
Thanks, that's what I thought. Let's hope that once we get approval this will change, and if not it will change once we're on a major exchange. I don't know that it's required by exchange rules, but I can't remember a company that hasn't done it.
Gary
Not being an attorney I'm wondering if any who are know just how many more times the MM's can file their MTD and Posner must answer before the judge call a halt and takes the case to trial, or settlement. I feel like the MM's legal team is working in much the same way at Trump's legal team to delay at all costs. I know that Trump isn't the only one who seeks such delays, he's just the highest profile one. Frankly our judicial system works practically as slowly as other regulators, like the FDA.
In recent days I've heard of at least a few Drs. who're getting experimental treatment for deadly cancers. I really wonder if developments wouldn't be substantially accelerated if some of these people were asked to participate with the FDA and other regulators in making their decisions. Even if they've managed to get the experimental treatment of their choice, I believe such people could get the regulators thinking of ways that they could expedite getting such treatment to patients. Why not do what was done with Covid-19, issue an EUA which allows the product to be sold, and covered by insurance, while full approval is being evaluated.
Gary
Thanks, I know I'm not a technical expert, I really don't try to be, but I do like the roll of devil's advocate, stirring up some discussion that perhaps we all can learn something from.
I really believe that NWBO has the potential of being the best investment of a lifetime, but nothing is ever guaranteed. For me, and I believe most longs here, just UK approval will make it a good investment, more than a double, perhaps a five banger or more. I believe that's tiny compared with how big we could be, but that alone would be success for many of us here.
Gary
Pegs, while that would be spectacular if done without an R-S, I could live with one if it is not too severe. The goal of getting on a major exchange would make this a very different company, that's what I want to see.
Gary
Some people enjoy my dissertation. Others don't. Feel free to ignore me.
Gary
When I recently invested in the company it wasn't in the belief that they had the cure to AD, RETT's, etc. I believe that these, and other diseases are rather like cancer, you keep coming up with new treatment that improves on the old, but no magic bullet is coming along that simply cures everyone. In my opinion we're making improvement in the treatment of these and other diseases, not a cure, but an improvement that could become a part of the SOC for a significantly long time and should bring in multi-billions annually once they're accepted.
I don't know if the company will exist after multiple approvals and billions in sales, or be bought out, but either way, investors should be well rewarded. The key is getting that first approval.
Gary
Our current market cap is under $600 million, hardly what would be expected for a company near approval of a potentially blockbuster product being approved near term in the UK. The question is, what should our market cap be after UK approval.
Personally I can't imagine anything below $2 billion, but expect it could be much higher in the $5 to $10 billion range. I believe much depends on the media coverage we get on release of the news, and then on what's planned to follow it.
I've not spoken with DI for some time, however others who have make it sound like far more than UK approval will be rolled out after the UK approval. Certainly we can expect the announcement of an Annual Meeting. Is it possible we'll also get news of submissions, or planned submissions to other regulators. An EDEN update certainly is possible, could we be closer to its acceptance than we think. New trials should certainly be in discussion in the not to distant future, perhaps in partnership with other companies.
My point is that depending on what's rolled out, and the timing on all that should be happening during the remainder of the year, our market cap by years end could be as low as a few billion to as high as well into double digit billions. Unless some country piggy-backs on the UK approval, I don't know that we'll have additional approvals this year. As a guess, if anyone were getting in on the UK approval it could be the Canadians given their close relations with the UK. I would suppose the same could be true of places that weren't involved in the trial, but are closely related to the UK, like Australia. Not everyone would wait for the US approval to act.
The market cap today certainly indicates that few who know of NWBO believe the approval is that near, but when it happens they'll be proven wrong. I suspect that most of the new investors who invest on the news of approval will not have heard of NWBO before that day. If media coverage is strong, and investment becomes emotional, no telling how high the market cap could be taken by investors who look at a stock based on its price, and not its market cap. A $20, $30, or even $50 stock sounds cheap if the headlines say the technology may be applied to all solid cancers, and frankly it could be cheap after it's proven to work in most solid cancers, but in looking at the shares outstanding it's not justified by UK approval for GBM or even all brain cancers alone. It's never been my intention to sell the majority of my stock, but if emotion takes over and carries the stock well over a $10 billion market cap, I believe many of us would be either selling, or placing trailing stop loss orders to guarantee tremendous gains, and looking to purchase substantially more stock after a healthy retrenchment.
There have only been a few times in my life that I can remember such buying on emotion, the biggest was based on a NY Times article on Judah Folkman that took a company from $1 to over $100 on curing cancer in mice. I'm not saying this could be repeated here, but in that case, it cured mice, not people, in our case, over time, it may be found that our vaccine does provide substantial benefit for patients with many forms of solid cancer and over time that should justify triple digit billion market caps, or more.
Gary
I have been told previously that Journals give days to weeks notice, not months, if true it should happen this month.
Gary
My stock addition is about 40% of the volume today thus far. I frankly have no idea how many shares I will end up with when all the dust settles, but I think it will be worth more than I have invested to date.
Gary
Out of curiosity, has NWBO always just dropped their quarterly and Annual Reports, or in the distant past did they announce when it would be released. Back when they were on the Nasdaq, did they also do webcasts when the quarterlies occurred.
I don't believe that what they're doing now isn't legal, but other companies call attention to themselves by announcing when the financial reports will be issued, and of course most of them follow it with webcasts to discuss it. Let's hope it's not too long before we're doing it that way.
Gary
Any feeling for whether the company will provide a quarterly report this week. As I see it, the quarterly should be independent of what's happening with other things that are happening.
Gary
I believe the moderators should sticky this post if the company fails to PR this presentation shortly.
This is really the sort of thing that should be PR'd by the company before it's discovered by investors, unless they're embargoed from doing such things until some date.
I wonder when there intentions on ASCO will be announced. I still like our chances of approval in the UK before ASCO starts.
Gary
Great find, hopefully we'll have the UK approval before the presentation.
I wonder if it's possible for the company to put the presentation on their website after the conference ends.
Gary
No, she started with a rare form of kidney cancer that normally is very deadly, but was thought cured after 10 years. She had some good years before it returned with a vengeance. I hoped that DCVax-Direct might be available in trials, but clearly it didn't happen. She did have surgery, then substantial chemo, but she refused additional surgery which might have given her more time, but couldn't possibly be curative.
I've recently had a few friends choose quality of life over duration when it came to treatment they'd accept. The beauty of our vaccine is that it offers both quality and duration, especially if the right other therapeutics are combined with it. I often think that drugmakers fail to emphasize the quality of life with their products when they're not found to extend life more than the SOC but in fact are easier to tolerate for the patient.
Gary
I may be mistaken, but I believe you file for approval. If the regulator conditions the approval to requiring some further confirmation in the future, you except it. It might be different if you're going for approval out of a Phase 2 trial, and already have a Phase 3 trial running, but I wouldn't want to propose doing another trial at the time I was asking for approval based on the Phase 3 I'd already run.
I'd be more inclined to suggest that all patients receiving the product post approval reported the outcome into a Phase 4 database. I really believe that should be the case with all new products, then problems with products couldn't be hidden behind settlements with non-disclosure agreements.
Gary
Flipper, it would seem to me that an mRNA vaccine that was intended to prevent the onset of cancer, or used on discovery of cancer prior to surgery could be beneficial, likewise once the cancer was detected DCVax-Direct could be effective prior to surgery. Once surgery occurs, I've got to believe that a vaccine that's made from that specific tumor would be more effective than an mRNA vaccine.
I'm certainly not an expert, but this would seem like common sense to me.
Frankly when my wife was determined to have breast cancer, over a quarter century ago, I was surprised at the time between discovery and surgery, it took months, and today it seems no different. I believe that treatment with DCVax-Direct could be initiated within weeks of discovery of an operable tumor, and should be injected into that tumor well before surgery. The greatest benefit of such treatment would hopefully get some anti-cancer action into the mets which left untreated can result in the cancer returning years, even decades later in multiple organs. If the mRNA vaccine could potentially do the same, perhaps both should be used.
If the mRNA vaccine is given as a preventative to cancers, like many other vaccines we all take, once a cancer occurs in a patient who's already had the vaccine, I don't know that more vaccine would have any effect whereas both DCVax-Direct and L post surgery should be effective. We know that by themselves they're not curative, but other therapeutics become more effective and lives are certainly being lengthened and at some point the cancer may be determined to be cured. I frankly don't know if all the longest living patients treated with DCVax-L are considered to be cured. It's been 10 years since I had stem cells for leukemia and I still return to City of Hope quarterly to determine I'm still in complete remission, I cannot consider myself cured as long as my Dr. still believes such testing is necessary.
I should note, my sister was thought cured by her oncologist until a body scan done by her new internist found tiny tumors in several places that ultimately proved fatal, it was roughly a decade after the initial cancer was treated. I don't believe the old sentiment that after 5 years cancer free your cured is currently considered the SOC for most cancers.
Gary
It's interesting that Dr. Liau is not yet speaking about what happens when DCVax-L is combined with other therapeutics. I believe the reason is based on the formalities applied to clinical trials in which nobody speaks officially about advancements until they've in some way been presented for peer review. Let's hope that happens in the near future.
To my way of thinking the entire process of developing new products takes entirely to long. While a company can release a TLD statement, it's very general, just an overall impression of what they've seen, and as we know the peer review can take a year or more before either Journal, or acceptance at a proper conference occurs. How many lives could be saved if the regulators really got into what was seen in a trial and if justified did an EUA to make the product available while all the formalities of peer review and formal filing for approval, often in excess of a million pages, is done over what's often in excess of a year.
It's not that no data has been revealed from the trials at UCLA, interim results are spectacular, but in a formal presentation by Dr. Liau, she's apparently not discussing them. I feel certain that if she were treating a patient with DCVax-L they would also be receiving Poly-ICLC. I don't know if the company is permitting her to treat such patients if they're not officially in a UCLA trial, though she clearly knows how to make the vaccine herself.
Yesterday I saw a neurologist because of essential tremor, which is hereditary as my father had it. While she doesn't suspect anything, she's having me do a brain scan, which I've never had previously. While I've been very pleased with City of Hope, if there we a problem requiring surgery, I'd probably try to go with UCLA and Dr. Liau if possible, only because of the after surgery treatment that may be available there, and nowhere else, at least right now.
If the EUA were used more frequently, I would suspect the regulators would have had sufficient evidence to do so back at the point where the trial was resumed after the halt. I believe the German's insisted that all get the vaccine because they clearly saw the benefits, and the others did come over to their way of thinking. I suppose the other aspect of using an EUA would be having a production facility that wasn't fully approved for commercial production, but was qualified to supply pivotal quality trial material. How many tens or hundreds of thousands of patients might have been benefitted if an EUA had been done back then?
Gary
I don't know if anyone knew the size of the trade, anyone see it?
Gary
I am still curious about the after-hours trade on Thursday. If the trader does have some information, it would have been normal to believe it would be released on Friday. The company, on the other hand, should know that good news is best released early in the business week and does have the flexibility to do so.
If there is anything to this Monday, it should be very interesting.
Gary
We know they have St. Gobain's Glass for production of the disposable cassette, I believe they can produce virtually any quantity that NWBO wants. In terms of the EDEN unit itself, I'm sure that several companies would be capable of either building the entire unit, or building components that the Flaskworks personnel could assemble, test and certify.
I believe the EDEN units will be leased to those authorized to make the vaccine, NWBO will be responsible for all maintenance and upgrades, and I think they'll track each cassette to the machine that makes the vaccine and it's proper disposal. The question is whether Flaskworks will assemble the EDEN's from contracted components, or just certify each unit prior to delivery to the producer, and then maintaining and updating it as applicable. I think that Flaskworks will be a profit center of it's own.
Gary
Thanks, I think I may have after hours authority at Fidelity, but didn't think OTC was covered, clearly it is. Pink's aren't, and that's fine with me.
Let's hope that purchase is based on someone knowing something. The other possibility is someone put in a market order after hours and the MM's took total advantage of them. Market orders have risk anytime, but after hours I believe you're exceptionally vulnerable to MM's playing games as practically no trading is going on, especially in a stock like NWBO.
Gary
I didn't know that you could buy after hours on the OTC, but perhaps on a foreign exchange. If this is real, someone knows something.
Gary
Doc,
To my way of thinking, the real question regarding production of the vaccine is what the capacity is for whatever company, or companies, is for making the EDEN units and disposable cassettes. I don't know if estimates that some made of the EDEN costing tens of thousands each when mass produced, but if true, well over the cost of making it is returned in the first batch of vaccine that's made in it. I believe that if worldwide demand were a million batches a year, we could find, or build cleanrooms capable of supporting 20,000 EDEN units which at 50 batches a year give us 1 million batch capacity. I suspect that CRL could house all, or most of the EDEN's in existing facilities they have worldwide that already have cryogenic, and other support needed.
I would think that if the demand is there to build 10,000 EDEN units a month, at the right price manufacturers will materialize who can do it. I'm not saying that many are necessary if production proceeds approvals, but if substantial numbers don't exist at the time of approvals, rapid production may be needed, especially if off label use in other solid cancers is available.
Gary
In roughly the next week NWBO should issue their quarterly report. Unless we have action from the UK, it's doubtful if they'll say anything beyond the filing there. I believe that if they wished, they could gain an additional week if they thought there would be more to report in the additional week.
As of today, the 150th day is just under 3 weeks away, the company certainly knows if they got an RFI or not, which would give them a clue when they should hear from the UK, but I doubt they'll say anything unless they have something official from the UK. As for anything new on the EDEN, perhaps if something worthy of discussing has occurred, we might hear of it in the quarterly.
To me it would be big news if they broke their tradition of only releasing the formal report, but no webcast, if in advance they PR'd a quarterly release coming on a specific day, and a webcast very shortly thereafter.
Gary
I don't believe that has to be true. Remember, I'm not saying for every trial, but if the DSMB or lead clinician believes such action worthy, it could take far less action at that point to make such a decision than waiting years and reviewing applications that run to over a million pages. I believe a fairly small panel of expert Drs. actually seeing what's happening at key trial sites would take a smaller effort than evaluating a BLA or NDA as applicable.
Gary
You're right Joe, I was suggesting a massive change, I don't know if it will ever be made. I'm sure we've not yet had a filing with other regulators as if we did, it would be announced. They're preparing to do so, but that can take a great deal of time, I have no idea just how close they are.
Gary
I've got to suspect that knowledgeable brain surgeons over the last few years have had their patients tumors properly preserved on surgery. Certainly many of these patients are no longer with us, but some are and may still be in a condition where the vaccine could provide a major benefit. I have no idea of the numbers, or whether the company has in any way established anything with regard to these patients, but I believe for some time the annual demand may exceed the number of new patients expected to be diagnosed in a given year in the geographical location it's been approved in.
As I understand the application, it's for all brain cancers, not just GBM. While that's certainly a bigger number, it's nothing like what would happen if off label use is available for other solid cancers. I cannot say if such off label use can be provided by paying a premium, while the demand for brain cancer demand can't be fully met, or if it only can be added when all label demand is being met. I do believe that new trials will be opened for other solid cancers, but they'll only handle a tiny fraction of those wanting to get the vaccine.
It looks like we were taken down once again at the close, we were down just over a quarter-cent just prior, but brought down by half a cent more at the close. Amazing how the MM's manage to do that day after day.
Gary
Scotty, while I'm inclined to agree with you, it's been a few years since I mentioned it to my back surgeon, who's also a brain surgeon, and I found he knew nothing about it. When I mentioned Dr. Liau's name he not only knew her, but had worked with her and almost immediately he and many working with him became investors. I believe that you're right, brain surgeons throughout the world will get the word on the UK approval and they'll help push for approval elsewhere. I also believe they'll learn of the use of Poly-ICLC and/or Keytruda to enhance the benefits with our vaccine dramatically.
In the beginning, I very much doubt that the supply will be able to keep up with the demand until the EDEN unit becomes available. The biggest sales force in the world is useless if product cannot be delivered. With UK approval sales will be met through Sawston and provide some of the funding needed for the company to pursue the additional approvals which combined with EDEN approval will permit more product to be delivered elsewhere. I'm still of the belief that it will be CRL who'll be doing this production, storage and delivery. As for sales, as the word spreads to the worlds brain surgeons, little selling will be necessary, managing to satisfy the demand may become the tougher task as patients and their Drs. may be unhappy with being told their vaccine is scheduled for manufacture several months from now. A legal question may need to be answered as to whether it's acceptable to accept an additional payment for priority manufacture of the vaccine, if so, I would expect wealthier patients will make such payments.
Gary
Thanks for all the agreement, but sadly we cannot change the FDA or other regulators without immense pressure for change. I believe our FDA has become a little more open to change, but far from actually getting involved in trials and making a judgement for themselves without formal documentation that often goes over a million pages and adds perhaps a year or more to the process. Imagine the difference if the DSMB at 50% or so through a trial told the FDA to come take a look at what's happening here, and if you like it, approve it, or at least permit it's use for sale by granting EUA for now, with further results supporting full approval through a Phase 4 reporting the results of all who received the product.
I suspect that such actions would cut the cost and time required for many approvals dramatically, certainly approval with out a ton of paperwork would save years, and many millions. I also suspect that our regulators would get a far greater sense of accomplishment if they actually got involved in the clinic instead of reviewing a pile of data. JMHO.
Gary
I believe if the regulators would pay attention to the Hippocratic Oath they would approve drugs, like those Anavex has in trial, for broad use, but insist on conformational trials to maintain them on the market. I believe it's clear that patients either see benefit, or are no worse, in essentially all indications the drugs have been tried on. If something better than that were available, it would be approved, but it's not.
To me, a conditional approval is far superior to taking years, perhaps even a decade and hundreds of millions to run further trials while millions go untreated. With the conditional approval, I would have every patient have treatment results reported in a Phase 4 and that too could be the basis for making the conditional approval into a full approval.
I hate to continue saying it, but I believe the regulators should be far more pro-active. They should be looking into trials while they're underway and if they clearly see benefits, do conditional approvals immediately. In most cases this probably would cut off perhaps 5 years and a great deal of the cost of clinical trials and have the potential of saving many lives. I believe that benefits seen in most Phase 2 trials should be sufficient to see such benefits, and a million pages or more to prove it is ridiculous if the regulators could pro-actively speak with clinicians, patients, the DSMB, etc. and make a decision for themselves. If they don't wish to call them Conditional Approvals, call them EUA's. the point is not taking decades to take a product from preclinical development to availability to the patient. They did it for Covid 19, for the person with other deadly diseases, like pancreatic cancer, it's just as important to make miraculous products available in months, not decades.
Gary
The question is well covered by the expression in the TV show, what would you do.
If you're suffering with a cancer and the best thing being offered is CAR-T, but the risk is a future cancer, what would you do.
Sadly we're learning that we really can't know all the long term side effects of all sorts of things we eat, drink, etc. all the time. Some things are rather predictable, like smoking, but others certainly are not. The Covid vaccines no doubt saved millions of lives, but a few may have died from it. Herceptin, and other drugs like Kadcyla developed from it, has been a miracle worker in Her 2 positive breast cancer, but a allergic reaction in a tiny percentage has been deadly.
I believe our vaccine will be found to have virtually no substantial negative side effects, but if applied to millions, if even one passed on shortly after receiving it, it would be suspect unless something else was found that caused the death.
As long as a patient has choices they may not choose CAR-T, but if nothing else offers possibilities, death is the other choice. Some people do choose death over the treatment that sustains their lives, especially when the likelihood of a cure is approaching zero. At this point, no one really knows if in any given patient our vaccine could result in a cure.
In 1994 my wife was being treated for breast cancer with chemo after surgery. She met a gentleman who was given less than 3 months to live with treatment. He and his wife had always wanted to see parts of South America, and his Drs. agreed to a 2 week vacation there provided he take treatment just before leaving, and immediately on return. When he returned, no cancer could be found. I have no idea if his remission was sustained, but believe he lived far longer the 3 months. I don't know if our vaccine could cause such miracles in some patients and we'll really never know until it's tried in millions of patients.
Quality of life often fails to get enough attention, it should be one of the biggest reasons to consider our vaccine. It's rare that a cancer therapeutic not be accompanied with negative quality of life issues, this appears to be the case with our vaccine. Certainly it probably will require others with side effects to achieve big benefits, but the side effects are still far less than SOC treatment, as I understand it.
Gary
Iron Mike,
I'll agree with the fact that the company is aware of what's being said here, but I'll disagree that the company will continue to operate in a secretive style once they really have something to say. LP clearly avoids discussing what the company is doing when she really has nothing new that she can say. I believe this will change dramatically when she does have something to say.
Frankly she went overboard when she announced a date that they'd file in the UK, then had to back of twice as delays that were out of their control occurred. The most I've heard from most other companies was an intention to file in a given quarter, had she simply said fourth quarter she'd have been fine. Likewise, I think time to acceptance of the EDEN is largely in the hands of others, at this point if she said she expects it this year I'd appreciate that.
I don't believe I've ever heard any company say a RFI was received from any regulator, nor do they discuss any meeting they have with regulators, and certainly not any serious discussions with other companies about possibilities, which are always done under confidentiality terms. When something is ready to announce, it's announced.
For years IMGN had been saying they were looking for geographic partners for their drug, Elahere, but at no time said they were actively seeking to be bought out. The announcement of the buyout was the first mention, and it was so far along it was completed in a couple months, whereas the likes of SGEN had taken years. I frankly hated it, though I was certainly better off financially, I believe the company would have been worth far more if they waited for sales revenue to develop.
I'm sorry LP didn't have an Annual Meeting last year, but I understand that she had to feel she'd be inundated with questions on material she really felt she couldn't yet properly discuss. She's clearly waiting for some success to hold an Annual Meeting, and I suspect it will be for both 2023 and 2024, or just 2024 and ignore that no meeting was held in 2023. Certainly if shareholders had gone to court a meeting could have been forced on the company last year, but the OTC doesn't seem to care, and frankly I'm not sure the bigger exchanges would have if shareholders don't lodge a complaint.
I believe that LP controls enough shares to assure a positive vote on any issue she wishes to raise, but I really believe she'd rather bring up issues that logic says most investors will support and have little opposition. To me, taking on an equity partner, or any type, will require more than the 1.7 billion shares currently authorized. As our share price rises dramatically such a partnership may become possible, that would be when additional shares ought to be requested, so I can't see it being brought up until that occurs.
I look forward to the day when LP, or others from the company, routinely appear at Investors, Brokerage, and Institutional Conferences, but it won't happen until our vaccine has at least UK approval. I believe the company will be very different once that happens and DI has alluded to it in discussions with various posters.
I hope each day isn't a binary event, down if we don't announce approval, up dramatically if we do, but I suppose it's a possibility. If we've had no RFI, we're speaking of under 15 trading days, but if we had a RFI it could be as many as 55 trading days. I really don't believe the UK will provide any hint of when they'll announce, but certainly I could be wrong about that. Practitioners of TA will say there is always a Tell, but if there is, I doubt if many of us will see it, but they'll point to something and say, this is how I knew. Rarely do they announce knowing before an event occurs.
I'll certainly admit that I have no idea what the company intends to do when notified of the UK decision, which I feel about 90% positive about. At minimum, we'll get a PR, but the maximum could be webcasts from the company, and a major campaign in the major media worldwide. That's a very broad spectrum, but anything is possible. Both the FDA and SEC abhor hype, but announcing what truly is a new paradigm in the treatment of brain cancer shouldn't be considered hype if after examination it's true. To add to it, what applies to brain cancers should apply to others isn't a huge stretch. If the media runs with the story, no telling how high the share price could go, but ultimately it will retrench some.
Gary
There is a protocol for releasing data that calls for peer review prior to open discussion of the data, often Phase 1 trial data isn't discussed at all. I would suspect that at an appropriate time the data will be discussed, but this trial wasn't sponsored by the company, so they really won't discuss it at all until after it's been presented in such a forum.
I would hope that it's not long before a Phase 2 that's designated as registrational, or Phase 2/3 Trial is initiated with NWBO being one of the trial sponsors.
I don't believe that TLD statements are normally issued for Phase 1 Trials, or by most trials run at research institutions, but Dr. Liau and others speak at many smaller, and larger presentations where discussing the data could be considered as proper peer review for a Phase 1 Trial. It's not impossible for a Phase 1 that's truly dynamic to be presented at a major conference, like ASCO, but it's doubtful this year as the Abstract would need to have been submitted back in February. Perhaps it would fit into one of the conferences closer to year's end.
Gary
I believe that the odds of getting the UK approval in the coming week should be about 20%. Last week I had it at about 10%, and if it doesn't happen this week next week it will be at least 10% higher, or greater. In three more weeks I still believe the odds go to about 90% but of course if an RFI did come in, it could take somewhat longer.
Personally while I don't remember which poster said no RFI was requested, it's was someone I respect and who I believed was living somewhere in Europe, so they could be in a position to actually know. Of course it also could be a good, or bad guess, but that's why I'm at 90% and not higher.
I'm in L.A. and generally like to sleep until the market's been open a couple hours, but I usually have a quick look when using the bathroom shortly after the open. One day I'll know we got the answer as my account could easily be worth a multiple of what it was previously.
Of course there is also the possibility the company would release news over the weekend, or after the market closed, or perhaps announced holding a webcast prior to the bell, that would be all I'd need to set an alarm and learn what's happening.
Gary
I'm happy that after a few months here you know far more than the company and four regulators they've been working with for well over a decade based on all they've learned during the trial. It's clear that instead of working with the regulators and establishing new goals for the trial when they halted it, so they could end it a few years later, they should have just stopped and taken perhaps another decade or so to get the job done, rather than working with the regulator.
It seems to me that you should be working for the company, perhaps they could just fire all the others and let you take over completely.
Gary
He's no different than most CEO's in that way, most quarterlies are scheduled on or near the last day they're supposed to report. I live in L.A., decades ago most quarterly and other presentations were scheduled about a half hour after the market closed. Suddenly I found most companies switching to an hour or so before the open. I asked my broker what was going on and the explanation was simple, nearly all the Analysts are on the East Coast and nearly all come in well before the bell to get up to date on the news. They complained that when the day ended they wanted to leave, not wait around for nearly two hours to first read the financial, then listen to the quarterly report which followed the release.
While I'm interested, I don't get up at 5 a.m. to see the release, or 5:30 to hear the call, and only rarely am up when the market opens at 6:30 my time. I may use the bathroom about then, so I'll take a glance, but unless I find a big move in one or more of my stocks I just go back to bed until I normally wake up, 1 to 3 hours later. One of these days, if I miss the open, when I do wake up I'll learn I'm half a million or more dollars richer, from NWBO news, I don't own enough AVXL to make that sort of gain, at least not yet.
Gary
Powerwalker, clearly they'll be speaking with a quarterly in the next two weeks, but how much they can reveal above and beyond a normal quarterly may be in others hands. If no material or data that's never been peer reviewed is released, they're limited about what they can say. On the other hand, if they're in control of an issue, like filing with a regulator, they can certainly update about that.
I know that when they discuss million page filings there are companies that specialize in getting them out, just the announcement that such a company has been engaged would be positive news rather than trying to do it all themselves. I'm frankly unsure if even the BP's do it themselves. If they were to announce an intention to file somewhere no later than say the end of the third quarter, it would be greeted positively.
If you're right about discussions with one or more BP's, it would be big news to indicate they're in a quiet period, so it's cannot be discussed. Sometimes the best news available is that we're not free to discuss anything. During such periods they're still required to issue financials, but the failure to say certain things in the financials may be telling a story by itself.
I do suspect that sooner, or later, a BP will either partner, or look to buy the company. Personally I would like the price much higher before it happens, but that can only happen with one or more approvals. Offers very rarely pay more than double the current price, I would hope the company's trading in at least low double digits before considering any offer. Under confidentiality agreements, a potential partner, or buyer, would gain access to all the data we're being denied until it's peer reviewed. That's information that could lead to a much higher offering price, but only after the stock price reflects the news that's not yet been released to investors.
I for one believe that when we get the full story on RETT's we may see a possible path to approval without further trials, but that's purely my opinion. On more than one occasion the regulators have agreed that more than specific goals in a trial should be considered if a product has some benefit where nothing else exists.
Gary
Powerwalker, I'm sure you're right about the company doing the quarterly webcast in a timely way, and yes, they certainly speak with investors whereas NWBO doesn't do such webcasts, so all you get is the written text. As for the Annual Meeting, if Missling gives investors a reason he'd prefer to wait, I believe investors would support it.
Investors want to hear more about the data, until that data's been presented for peer review, the company shouldn't do it. Wouldn't you rather have a Journal out, or peer reviewed presentation first, then have open discussion of the data, or have the meeting and be told that the data won't be discussed until it's been peer reviewed.
I don't believe Missling will delay more than a few months, but I'd rather have a meaningful Annual Meeting in perhaps August or September than a meaningless one in May, June or July.
Another possibility does exist, but only after peer reviewed data's out. Hold a Science Day. It's really just a few hours, but allow the scientists to do far more of the presentation. I don't know them, but hopefully among them there are better presenters than Missling. I know other companies have done Science Days so when the time's right, why not AVXL.
Gary
You're correct, if either NWBO or a contractor decided to build a major new manual production facility here in the US it would be acceptable, but I don't believe they've made that choice. I believe such a facility would cost tens to hundreds of millions and might not be completed before the EDEN was available. If I'm right about biological products not being importable to the US, no matter how much capacity is added at Sawston, it will be of no benefit here in the US.
One large cleanroom with 100 EDEN units would probably cost less than ten individual cleanrooms, each with their own HVAC system to assure no cross contamination between rooms. Even if US approval is delayed substantially, I believe that's the course the company has chosen, probably with the concurrence of CRL who I believe will be contracted for US support, but if they determined to do it themselves, it will be with the EDEN unit.
It's never been about whether it can be done manually, yes it can, but a decision not to do it that way is up to the company and I believe that decision was made some time ago. The company is making and qualifying the EDEN units in Sawston, once it's approved there I believe they'll get little resistance from the US, or anywhere else. I believe that CRL has sufficient cleanroom capacity to operate hundreds of EDEN's or more without requiring new structures to be built in Memphis, they have other facilities that can probably be adapted as well worldwide.
It's rather interesting that shorts are now fighting about US production when previously they indicated that the FDA would never approve the vaccine, that's a refreshing change. I wonder how AdamF feels about it.
Gary