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I really believe that it won't happen that fast, we'll have at least UK approval and the naked squeeze will occur well before even the earliest settlement could occur. I believe that the MM's will be burned in the short squeeze, but their clients even more. I should be fun once we get the UK approval.
Gary
I think that if the judge eliminates all further possibilities of stalling an offer could be forthcoming before anything proceeds any further. The longer the MM's keep this going the more it's costing them, if it's clear they have a losing cause why put more bad money after good. I believe that Posner knows she has a winner and won't abandon it without a substantial offer.
Gary
Let's just hope that Ken Griffin hasn't donated billions to others who have influence on FDA and other regulators like he did with Harvard. I doubt if even there many experts would oppose DCVax-L, but a few who use the electronic helmet have little trouble in having their arms twisted.
I hope it's not that much longer before we learn more about our case against the MM's, led by KG, but he's far from the only one involved. In my gut I don't believe it will ever go to trial. I doubt if the settlement can be completely hidden, but clearly NWBO will be on the winning side.
Gary
My belief is that they do have the people who can get the job done, but they must decide where and with witch disease.
Gary
There will always be experts, Drs, etc. who will say that any regulator that approved DCVax-L has in some way lowered their standards. The truth is that they have changed them, but it is a change that is long overdue.
Gary
I'm not speaking of published milestones, I believe that certain events are key to advancement of the company, and I have called them milestones.
If NWBO had partners, and if those partners paid when certain things were achieved, they would formally be milestones. As of now we don't have such partners, but I still think that calling such key event milestones is just putting emphasis on their importance.
Gary
Here's a post with all the recent buyouts. Note that those that are several hundred percent above the current prices are generally in the lower millions, when you get into the billions it's rarely much more than double the current price or nearly that.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174214652
Gary
I'm speaking of keys like UK approval and/or acceptance of the EDEN unit in commercial production. Filing with the FDA or others should probably apply as well. LP would be facing an enthusiastic audience once one of more of these milestones have occurred, and the share price ought to be dramatically higher.
Gary
With all the delay we've had, I believe it's clear that the company doesn't intend to hold an Annual Meeting until one or more major milestones have occurred. If they get approval in the next 6 weeks I suspect that we'll get an Annual Meeting in June and it will be intended to cover both 2022 and 2023. Ideally Annual Meetings are held mid year, NWBO hasn't been living up to what's normal for a few year and the regulators seem not to care at all, perhaps this is truer on the Pinks and OTC, but clearly unless shareholders sue to force a meeting, the company can do whatever it decides to do.
On the pinks I've seen a company not file for years, then suddenly past due reports were filed, and the corporate shell sold for next to nothing, and it was all deemed to be legal.
Gary
The question I would ask is, are the people there capable of developing a proper application for regulatory approval. As long as the answer to that is yes, perhaps with contractor support, in the long run we should be fine.
Gary
Does anyone know the meaning of featured exhibitor, NWBO has that designation.
I happened to also note IMGN is listed, apparently they're presenting as a subsidiary of ABBV.
Gary
I agree that the regulators all worked closely together during the trial, but I'd be very surprised if the FDA accepted only because the UK did. I wouldn't be surprised if the Canadian's chose to accept the UK's word and approved it for Canada. The EU on the other hand would have been a part of the approval had it not been for Brexit. I don't know that they may not consider approval on review of what was presented to the UK.
I'm certainly no expert on these things, someone else with some expertise is welcome to chime in. I'm as interested as anyone here.
Gary
If you believe in Anavex's science, and you're right, I believe you'll be rewarded even if the CEO's weak. On the other hand, if you have bad science and the most successful of CEO's, it's doubtful if it can be overcome. It's taken decades, but I believed in IMGN's science and it passed through several CEO's, some better than others, but eventually the science made me a nice profit. I really didn't care for the current CEO selling out when he did, but it still was a nice profit.
Gary
BB, I didn't mean to sound negative, just realistic. We're down to what should be our last few weeks of waiting. My comments were intended to admit that the regulators can never be totally relied on not to cause delays where they really aren't warranted. I believe the UK will approve DCVax-L before June, but if I'm wrong and even a few more months were added it wouldn't be the end of the world.
As Druggie said, I do stir the pot, I acknowledge not being an expert, but like to hear from others who are, but in plain, understandable English.
I don't believe that you need to be knowledgeable in the field to be successful in investing in it.
It's been over 40 years since I was first surprised by FDA action. All the world was certain that Genentech's THC would be approved by the FDA. Having little to invest, I bought options that should be well in the money after approval. Rather than approving, the FDA asked a question that had never been discussed in the design of the trial, it couldn't be immediately answered, and approval was delayed for some time, and of course my options were worthless. Of course we know THC was ultimately a blockbuster product, but I learned the lesson that you cannot be absolutely sure what regulators will do, at least not in the short term. In the long term, no drug that I felt certain of approve didn't gain approval, but some like THC had delays caused by the regulators, mostly FDA, but others too sometime don't do the expected.
If I were to put a percentage on it, I'm over 90% certain we'll be approved without a serious delay. I would suspect that if Analysts had been asked about THC being approved on initial approach to the FDA over 90% would have practically guaranteed it.
Gary
It was an old stock broker who'd explained to me how the MM's would use market orders to drop, or raise the share price in the manner that occurred today. A market order assures execution, but you may buy at a much higher price than the current ask, or sell well below the current bid price as the MM's play their games. I don't think things have changed over the many years that my broker explained it to me.
Of course today computers have much more to do with trading, but I still believe that market orders are where the MM's have the greatest opportunity to play games.
Gary
In the 2022 Annual Meeting shareholders voted to raise the authorized shares to 1.7 billion. Is there anyone here who doesn't believe that LP has the right to use those shares to keep the company operating.
Many people oppose dilution, but I'm not one of them if the reason for it is justified, and I believe that LP has done an amazing job in reaching the point we have, and fully believe that she's the person who can take this to the finish line. More shares will no doubt need to be authorized in the future if shareholders want to maintain the company's ability to partner or fund major future development in a timely way.
Gary
Does anyone believe that Posner can look at action, like today's close, and add it to the evidence of manipulation by the MM's, and add it to our case. I believe the only way we close on the low of the day is for the MM's taking advantage of someone foolish enough to put in a market order to sell right at the days end and the MM's doing their thing to make it happen at the lowest possible price. People need to realize that the market isn't truly fair, if you want to sell and be reasonably certain of executing, put in a limit order at the bid price, or even slightly below it, it's almost certain to execute, and often above your limit. A market order can and often does get a price that's lower than the bid price you're seeing and the MM's can get away with it.
Gary
We're now in a period that's somewhere between 10 and 40 days of a UK decision, the fact that our share price isn't moving up dramatically has to make us think the bashers and shorts have certainly created major doubt in the investment public. Certainly it's not impossible for the UK to not make a decision in this time, they can always do so, just as the FDA often does, but I really don't believe that they intend to do so. As a long I certainly believe they will approve, but like every decision of a regulator, nothing is a guarantee until it happens.
I've had a few friends considering buying in, or buying more, they've asked my thoughts and I certainly have been clear about the fact that a decision should be forthcoming shortly, but I can't say exactly when. If you don't invest before the decision, if it's positive, the way I expect it to be, you'll have to pay far more for the shares. If I'm right, and they don't buy, I know they'll congratulate me for sticking to my guns, and some may invest at the dramatically higher price, while others fret about another missed opportunity. I believe by no later than the end of May we'll know something, but that something might be that we have a further delay. I don't believe the price goes dramatically lower on any delay that doesn't require an additional trial, which would be years of delay. Some additional information, which can be provided in months, is practically an assurance of approval after those months. While I don't believe that will happen, I believe that somewhere in the 1.7 million pages we submitted, it's all there, but of course I could be wrong. If we've not received something by the end of the full 150 day period we were targeting at, I believe the company should explain why. I don't know that they'll do anything, I'm only indicating what I think they should do. If I remember correctly, my T-number is now 41.
The MM's have apparently once again taken control at the end of the trading day, we were up a minute or so before the close, but they managed to bring us down at the end of the day. Amazing how they can do that day after day.
Gary
If you look at her other companies that recently had their approval I believe that you'll find that most have market caps at $2 billion plus. I believe that our vaccines potential is far greater than most of the others, so a market cap in the $3 to $5 billion is very possible on initial approval. It will grow as additional approvals occur and revenue grows.
I think that we agreed that today is T-41. Only 11 days it we're on there faster
Lykiri,
I don't know what Ashkan does or doesn't do, but aren't the patients also under the care of their own Drs. If so, couldn't those Drs. be adding POLY-ICLC to the treatment.
Gary
It's true that Poly-ICLC isn't approved in this application, but it has been FDA approved in another application, you'll find it here:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174192543
This should mean that Poly-ICLC can be used off label with DCVax-L or any other disease that a Dr. wants to prescribe it for with the patients agreement. Given the trial results developed at UCLA I doubt if Drs. will have much trouble getting insurance approval to use it in combination with DCVax-L in brain cancer. Other cancers will probably require more anecdotal evidence.
Gary
I'll admit to lazily picking a date that was in the middle of a range posted by someone else, if T-42 is more correct, I'm happy to go with that. I also wasn't the one to discover the earlier goal the UK indicated they'd target to, but have referred to it enough that people are crediting me for finding it. If T-42 is the correct date, but T-30 is the new target date, that would be saying we're 12 days from the targeted decision date. That too sounds great to me.
Many here were very critical of the company when they missed on making their initial filing date, than even more criticism when it was further delayed. I believe it's very possible that the reason we're not seeing RFI's now is because of the changes that were made then. I believe that NWBO has been working closely with all four regulators all along and no doubt that has resulted in substantial delay as changes made awaited the acceptance of all four regulators. If one regulator wanted a change, I don't believe they proceeded until all four agreed to whatever the change was. Clearly it takes much longer to get 4 agencies all agreeing to the same thing, but I believe the payoff will come now as approval of DCVax-L will fly through the UK, and through the others as all terms they want in place are ready as well.
It's my belief that adequate commercial production is available, it can come from either the acceptance of the EDEN or substantial expansion of manual production capability at Sawston, and perhaps elsewhere. I'm unsure that the FDA may not require production capability within the US. The company may not speak about their plans frequently, and there are some things that cannot be announced until some preceding event occurs, but they have planned well for the future, and we'll all be well rewarded as they proceed with their plan.
I'll predict that once the UK approval is announced, then the Annual Meeting will be, and then we'll get at least some of the future guidance we've been eager to hear. I would expect that once again we'll appear at the Expert's Theater at ASCO, and perhaps there is a possibility that UCLA will be presenting info on their trials that add Poly-ICLC and/or Keytruda to DCVax-L in a peer reviewed presentation. Clearly it's an early stage trial, but with approval of DCVax-L in the UK anticipated UCLA may have considered the submission of an Abstract. If not, perhaps at one of the other major conferences later in the year.
Gary
If you look at financials in the link you provided, they dao have some data, where is this coming from?
Gary
It is my belief that all four regulators know DCVax-L far better than most products they're asked to evaluate. Remember, all four agreed to a halt and changes once the trial resumed. All four agreed to change the trial goals from PFS to OS, they understand how pseudoprogression made the PFS goal meaningless. All four agreed when Germany proposed dosing all remaining in the trial, rather than having some in the control group, they abandoned the use of a control group completely, using historical information they had available for comparison.
I would also contend that all four know about the major advancements being made at UCLA, even if no data about it is being provided. I believe that as all four approve DCVax-L they'll also encourage the use of Poly-ICLC and/or Keytruda with it, even if no official action is taken to make that happen.
I frankly wish regulators would take more dynamic actions, if they don't grant approvals where they know of tremendous benefits, grant EUA's until sufficient data exists to make it an approval, and they should work with the raw data, clinicians, etc. and not require anything like 1.7 million pages to gain an approval.
Gary
I simply don't know what the next week, month, or few months may bring. If the peer reviewed Journal article came out shortly and a matter of weeks after that at least one regulator was filed with, I suspect that we'd have a very different attitude about Missling. I don't know that's happening, but I'm unsure anyone here is certain that it couldn't be. Frankly the CEO can only work to get these things done, he does almost none of it himself.
Gary
As I understand it, the 120 day goal replaces the 150 days, it's not added to it.
All these goals are simply targets the regulators are striving to. Our FDA normally shoots for 6 months in setting their PDUFA date for anything worthy of priority review, and that certainly includes all deadly diseases, like cancer. All the regulators can delay without denying, but I believe we're in a good position to get the UK decision on time, or early.
I forget who appeared to have relationships with the UK regulators, but I believed the indication that now RFI was generated in the initial review period, so I believe that we're on track for a very rapid approval.
The only approvals I've been involved with never had the sponsor say anything about discussions with the regulator from the time they filed until they received something official from the regulator. If it wasn't an approval, they announced what was being required, in some cases it was data they could get that wouldn't cause a major delay, in others it was additional trials, and substantial delay. In every case that I believed a product should be approved, it was, but in some case it was after a multi-year delay for the new trials.
Gary
Our numbers are essentially in alignment, but you should add a 120 day assessment possibility, it's real and it could happen.
I believe that our product warrants the fastest possible review period, so I choose to ignore anything over 150 days. That doesn't mean it can't take longer, but if it does it's only because the regulator requires additional information, which thus far doesn't seem to be the case.
Gary
It's my hope that we investors are like teenager's who pretty much believe their parents are dumber than dirt. By mid twenties it becomes amazing how our parents become much smarter. I think the same could be true of our assessment of the CEO, before approvals he'd dumber than dirt, but post approval we'll see him as a genius. This is nothing exclusive to AVXL, it's been much the same in most biotech's I've watched or invested in previously. Likewise, even the most successful CEO's seem to believe that things can be done faster than ever turns out to be the case. Perhaps it could be true that companies could do things faster, but they all must deal with the regulators and they tell time with a calendar, not a watch.
Gary
By my count we're at day T-45 based on 150 days, but the whole process could be shortened by 30 or more days, we could have approval any time in the next two weeks. The basher's are throwing anything against the wall they can fine, but nothing is sticking.
Of course even with UK approval they won't stop. The issues will change to the EDEN not being qualified, and the FDA never being willing to do what the UK has done. In short the bashers will bash until those who're paying them realize it's not working, or move to the long side themselves.
By this time next month we could be a very different stock, we very well might even be at a share price where we can apply with a major exchange once all requirements have been met. It's even possible that we could have new partners or contractors working to initiate new trials, etc. I don't know that it can all come together that fast, but I think it's possible if these things have been set in motion many months ago, but waiting for just one thing, the initial approval of the vaccine.
Gary
A Phase 4 can be done simpley by having all uses of the approved vaccine reported in a database. It would cover all off label use and some assessment of the outcome over time.
We're now at T-46 by my count on the 150 day scale. If the goal is substantially fewer days we're practically there. An approval next week wouldn't surprise me.
Gary
It's easy to see that they have control, all we can do is either watch and wait, or sell out. In that I like the technology they're bringing together here, I'm willing to watch and wait, and perhaps buy more if I like what I'm seeing. I mentioned EPAZ earlier today, and they too are doing some things that are apparently are also under management control. They too are working on improving batteries and drones. I believe if both companies worked together they could really produce superior products.
Gary
There are people on this board who I believe do have such information from credible sources, I believe that they know what they are talking about.
If I am right, we will know shortly.
Gary
Anything is possible, but I believe they really had intended to meet the 150 day criteria and after review have found nothing that's preventing them from meeting the faster criteria. We know that they're in charge, but the fact that no clarification has been requested gives me reason to believe our filing will come through with flying colors. I would not be surprised if we have approval next week.
Gary
Barnstormer, Fidelity hasn't taken NWBO shares for some time, but they are currently taking my holdings in AVXL. I would suspect that when we gain approval the shorts will be in a world of hurt on NWBO. They may be able to borrow shares short term, but they will be in a squeeze and forced to make margin calls in a matter of a few days. It should be very interesting.
I really believe that we'll have an answer from the UK before the end of April.
Gary
As a new investor here, and in another company CRTG, I see both companies in the midst of major changes themselves, but also see where there are synergies where these two companies should get together to make one another products even better. I certainly welcome others to take a look and see if you think I'm right.
Gary
We're at T-47 based on a 150 day approval period, but if they're trying to get it done in less time, we're roughly 2 weeks away. If as many believe that company has 4 days after they're notified, they could be notified any day. The question is, do they announce immediately, regardless of when they're notified, or do they stage it for better timing.
An old stock broker once told me that it's best to issue good news early in the business week, that way brokers have the most time to work with their clients. A week later it's no longer considered news. If you agree with this, I would think that if they got the word on Monday or Tuesday it would be released immediately. Wednesday would be questionable, and Thursday and Friday would almost certainly await a release before the bell on Monday, perhaps even Saturday or Sunday with a webcast announced to discuss the approval before the bell on Monday.
I certainly don't know what tact the company will be taking. I would hope that they've pre-planned their moves and it's just a matter of time until they execute that plan. I would hope that many things are tied to their plans, things like the Annual Meeting, discussing new trials, etc. Who knows, even one or more partnership may be pending this approval.
We really don't know if 150 days, or less is the goal, but regardless, after all this time it's not much longer. Don't let the shorts and bashers set the agenda.
Gary
I have a feeling that 5 to 20 days are as much time as we'll need. As to the posts being down, I think the longs are showing contentment with their positions, and the shorts/bashers are coming unglued. Try not answering a basher whos asking about things that have been answered many times in the past.
The question we ought to be discussing now should have to do with where the market cap should go with UK approval. Much may depend on what we're told about other future approvals, but I believe the UK alone should bring a market cap of at least a few billion.
Gary
On the 150 day format I have us at T-48. In the shortened format approval could come virtually any day in the next couple weeks. I still believe that we will average $.01 to $.03 right up to the day before we get approval.
Depending on what reaches the media when we get approval, I think that we can be in the $2 to $5 range at that point.
Gary
I tend to believe that most things we do can be simplified. I cannot believe that 1.7 million pages are required to gain approval of a drug and frankly think that if all the key people were brought together for a matter of days it could be done with almost no paperwork at all. I know this sort of thing will never happen unless something was done in the manner the Manhattan Project was done, but I've got to believe that things can be streamlined dramatically without losing integrity.
A lack of trust is largely what's behind all the documentation and red tape that turns simple things into complex ones. If key people were taking full responsibility for the actions of their companies, or agencies, trust could be restored and perhaps things could be simplified.
Gary
Sorry to hear about your ex-wife. The sad think about people like KG is that they're not all bad, or good, they do often give lots to charity, but at the same time pick companies to oppose. I wish I felt the half billion KG gave to Harvard wasn't influenced by tax benefits he'll get for doing so, but I suspect that tax benefits have a great deal to do with charitable giving.
I suspect that if there were no tax advantages to owning luxury aircraft, yachts, homes, etc. there would be far fewer of them built. I suppose it employs a lot of people, but I really believe the money can be spent more constructively elsewhere. When multi-billionaires like Warren Buffett openly state that they're paying lower tax rates than their secretaries you know it's the case. No one can blame them for using the law to their benefit, the problem is in the laws.
If it were up to me, all tax codes would be eliminated and much simpler laws, without loopholes, would replace them. To many companies earning billions annually are paying nothing, or nearly nothing.
Gary