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Jack, it varies with the conditions I put on it happening.
I previously indicated that the only way I intended to sell stock after approval would be if unrealistic highs were achieved post approval. To me that's something that's in double digits, but without seeing what's being said I really can't say how high.
If we got a tumor agnostic label, all earlier forecasts are out. I do believe that in time DCVax-L will be used for many cancers, but I expect that to take time. A tumor agnostic label would make that effective now. Sawston couldn't possibly meet the demand, unless it was simultaneously indicated the EDEN were approved, but perhaps that's what's caused the delay.
Without knowing what will be announced, and perhaps more importantly how it will be handled by the mass media, it's impossible to say just how high it may go.
In most cases, stocks that soar from $1 to $100 come back to earth, but depending on the news do they come down to $25, $10, $5, or all the way back to $1 or worse, much depends on what's said, and the company's ability to earn after all the dust settles.
Gary
I believe we're all frustrated by how long it's taking, and with virtually no guidance from the company the frustration has the stock price slowly trickling down.
I'd like people to consider a hypothetical that won't happen, but what if the company announced that by a date certain they'd have an answer from the UK.
I don't care the date they gave, I believe that by that date our price would be in the range of $.75 to $1.50 or more. So I'm saying most would think the news will be good, if they knew news was coming at all. I'd like to hear others thoughts about that.
Perhaps at some point we'll get some sort of leak from the British, it's somewhat normal to see a trading tell of something coming, but it doesn't happen virtually every time. My point is we'd move up if people knew with certainty that we'd have an answer, but without it, hard to say how much lower we might go, largely a fraction of a penny a day.
If I'm right about the $.75 to $1.50, that's the least that we should see with approval. Again, I believe much depends on how the message is delivered, if low key the $2 range may be it for the immediate future, but if we have major media coverage and if we're seen as a new paradigm in the treatment of cancer, no telling how high we may go.
Gary
Thanks Lykiri,
I've got to believe that Dr. Mulholland would know about Poly-ICLC, it would be surprising if he can't get that as well.
People with the funds will try most anything, if successful it will be difficult to know whether everything was needed. Sometimes the decision to try the unorthodox therapies first can be harmful, many believe that Steve Jobs could have lived longer if he'd not experimented so much before turning to approved therapies.
Gary
Clearly we know Dr. Mulholland knows all about DCVax-L, but we know nothing about the patient, like if the tumor is operable. I'm sure he knows of the compassionate use program to get DCVax-L, but only if there is tumor to make the vaccine with.
Without the full story it's impossible to know what the Drs. choices were in the treatment of this patient.
I doubt if we'll ever learn what's behind Dr. Mulhollands decision on treatment, or whether the tumor was operable, or had been previously removed, and perhaps not properly preserved prior to being treated by him.
Gary
To be clear, that was only discussion of the EDEN approval, not the UK decision on DCVax-L which should come any day.
To me the scrutiny of a machine or process that makes millions of doses of some product should be far more rigorous than a device that makes a single batch of vaccine for a single patient. Applying years of testing, or even many months for that matter, seems extreme for a device that makes four batches a month. If all observations and tests say the vaccine made in the EDEN is essentially identical, or perhaps even purer, than what's made manually, it ought to be sufficient as long as the EDEN operation is monitored and determined to be functioning properly. I believe that each EDEN unit is connected to computers and fully monitored for proper operation, but I don't know that for a fact. I believe that FlaskWorks should be monitoring every EDEN Unit put in operation and every unit should be their responsibility to maintain and update as necessary.
Gary
I do not expect a quarterly report anytime soon. I believe the company's fiscal year is aligned with the calendar year, so the next report will be an Annual Report which includes fourth quarter results. An additional month is allowed for preparing the Annual Report.
It's possible it could come late February, but without requesting an authorized delay I believe they have until the end of the first full week in March. I'm sure that all at the company would be thrilled to have an approval by then, but they can't make that happen, it's up to the UK.
Without an approval they can only discuss what they anticipate in the future, if they do get the approval first, the Annual Report might be far more informative about future steps.
Gary
David,
What you say is true. However, don't you think that well over 90% of what's in the UK filing, with changes brought about by questions or discussions with the UK authorities, will be part of the submissions to the three other regulators. I'm suggesting that their applications ought to be well over 90% completed, so things can happen quickly when they're ready.
I don't believe they'll be ready until they either have the EDEN approved, or feel certain it will be before inspections of a commercial production facility are required. I can't be certain of when that will be, but hope it's this year, but if it's next, so be it.
Many people seem to think the company can't go anywhere without a BP partner or substantially more funds. I do believe they'll need some funding, but I'm not sure that they must give away equity, or that it must be a BP.
My belief that CRL will eventually be responsible for manufacturing, storage, and distribution in much of the world utilizing the EDEN brings up the question of, on what terms.
I believe it's the terms that can be structured virtually an infinite number of ways that provides a great deal of flexibility to NWBO. If CRL agreed to terms that gave them some maximum figure for every batch of DCVax-L they made, they would pay NWBO some maximum payment up front to agree to those terms. On the other hand, if CRL agreed to take some minimum amount for each batch, NWBO might pay them for the service, or agree to supply the EDEN's to CRL at no cost to CRL.
I believe their agreement will fall somewhere in the middle, CRL will pay so much for the rights, they'll pay to lease the EDEN Units and for service to the units from the FlaskWorks division of the company. In short, the funding that NWBO will need may entirely, or largely come from CRL. It would also be possible that it's CRL who may at some point take an equity position in NWBO.
I don't believe anything happens before UK approval action, but after that, even if the EDEN approval is known to be awhile, an agreement could be announced with CRL which could provide some funding and support for bringing the EDEN through the approval phase.
I certainly don't know this will happen. I do believe that some trials will be done with products from the BP's, and they may pay NWBO for the rights as well as the DCVax-L they'll be using.
I certainly may be wrong, but I believe that the EDEN can be used to make trial material, even if it's not yet approved for commercial production. Such use would further validate the effectiveness of the unit, as well as DCVax-L.
My point is that NWBO can bring in the needed funds in several ways, and without a BP taking a substantial position in the company. I'm not saying that NWBO may not at some point establish an equity partner with a BP, I just don't believe LP will consider it until the BP is valuing the company somewhere in excess of a $20 billion market cap. That will take more than the UK approval to achieve. Frankly, if data, or the label from the UK goes further than brain cancer, I don't know that LP's ask shouldn't go to $50 to $100 billion market cap for substantial equity in the company. Of course I know nothing about what the UK label may be, but we all know that many cancers have been tried in the UK compassionate use program, the regulators there should have some idea of how effective it's been, even if only in a few patients with various forms of cancer. Could they say, we'll call it tumor agnostic, but demand it be confirmed with additional trials, or Phase 4 data. I believe anything is possible.
Gary
Gus, while I agree with you, it's not the only choice. I suspect that there are a lot of existing cleanrooms that could handle several EDEN Units if they wanted to license the EDEN to many sites, but I'm not suggesting they'd do that, just that they could. Likewise any number of BP's could build to the needed capacity if they partnered, or bought NWBO, but again it's very different from their normal business, I don't recommend it. I like CRL to do the job, but again, it's only one of many possible choices.
Gary
We're all entitled to our opinions, but you're telling me nothing about sales of DCVax-L or the earnings the company should be seeing.
I'll admit the company won't get rich on 1000 batches a year, even at $250,000 which they roughly get for compassionate care it's not all that much, $250,000,000 for which they'd be lucky to see more than $100 million in earning.
If a P/E of 30 did apply and 1.5 billion shares outstanding it's still a $2 share price. I think it will be far better as I don't think the EDEN will be that long and I also suspect that they can make more with an approved product than it's sold for in compassionate use, but the company want to keep cost down, so I really don't know what they're looking for.
Gary
I believe they have 20 of the tiny cleanrooms, each will produce roughly 50 batches a year. That's 1000 batches a year. I believe they'll need more than that for the UK alone, but it's a start. Sawston has large cleanroom being built for the EDEN Unit, I don't believe it will be that long before they'll be up and running. It might come with the approval in the UK alone, but once that's done the others will follow in the not that distant future.
As always, this is JMHO, the 20 cleanrooms came from reading someone else's posts, and my memory that the suites were being built with 10 cleanroom per suite. If I'm wrong about that, please correct me.
When I speak about Sawston not supporting very much in manual production, these are the numbers that I believed applied, even if I'm off by a figure of two it's not all that many patients getting treatment.
Gary
Let's make some assumptions. I used $27 as NWBO's share price, if 1.5 billion shares were outstanding, that gives it a $40.5 billion market cap. If we take a P/E of 10, it would need to be earning $4.05 billion at a P/E or 30 it would only be $1.35 billion. Frankly I believe with all these companies selling DCVax-L for GBM for one year their earnings will substantially exceed either of these figures.
That doesn't happen overnight, it might be 2026 or later before all four regulators approve DCVax-L, so 2027 or later before it's been on the market for a full year everywhere, but I believe they could be earning double digit billions by that time, and therefore a substantially higher share price than $27 regardless of the P/E you believe it should warrant. I believe with the growth of sales I think we'll be experiencing, a P/E or 30 or more will actually be warranted. Time will tell.
Feel free to disagree with me, but lets hear what you assume in arriving at your figures.
Gary
I'll ask you the same question as Marty, what price do you think NWBO will bring with DCVax-L being approved, and therefore part of the SOC for just GBM in all countries whose regulators ran the trial.
Give me a price, and perhaps a little reasoning on how you arrived at it.
Gary
Marty, my $27 price was based on DCVax-L being approved by the four regulators that conducted the trial. That would have DCVax-L available in all of Europe, Canada, and the US. What price would you predict if this were true and sales were coming in from all these countries for GBM patients alone.
How long do you think it will take if NWBO announces that it has international approval of the EDEN unit, an agreement with Advent and CRL, or some other company, to produce and handle the vaccine worldwide, and has submitted to the other three regulators.
Gary
I think people need to look at the Good, Bad, and Ugly thing about investing in biotech. If you're not willing to accept all of them, this may not be where you should invest.
The good, tremendous stock price increases.
The bad, big drops in share price.
The ugly, you cannot predict the time to either of the above.
If you've determined that the science represented by what the company's developed is good, ideally great, science and that in the end you anticipate an approved product and substantial sales, realize you'll have to live with all the above, but in the end you'll be up substantially, and if you're like me, they'll be no end.
If a company gives you ten times your initial investment, but there is no reason to believe it will stop growing, why sell. Good companies that give ten times can very possibly do it all over again. For us today, ten times is $2.70, is there anyone who's a serious long here that doesn't believe $27.00 isn't possible.
It's my belief that if approval were limited to GBM, but all regulators approved DCVax-L the price would exceed $27.00, I don't believe it will take that long. Once that occurs, if DCVax-L is found effective in other cancers, how's $270.00 looking, I think it's very doable, in time.
We all need money in time, when you do, if you wish sell some NWBO, but think hard before you sell it all.
If before it moves up it makes another substantial move down, if it's not based on news that sour's you on the science, if you can, why not buy more and average down. That's biotech.
Gary
Gus,
I too have suggested NWBO to many people who've bought, I've kept them up to date with my beliefs about what's holding up the success of the company. To the best of my knowledge, only one sold out, and that was years ago as he sells off any stock that's down for a tax loss at years end. Others may have sold, we're not that close, but I believe the majority are holding.
I cannot tell them why the UK is taking all the time it is, all I know is in time the UK will act. I believe we'll all be well rewarded when the UK acts.
Gary
Mani, all I can say is that part of the BLA submission included an inspection of a commercial production facility which must be approved by the inspectors. If you believe that the Sawston facility with only limited manual production would meet the FDA demands, that's your belief. I believe the FDA would demand far greater capability than that facility could produce, especially if it's already taxed to meet UK demand.
In that NWBO or any of its contractors have not announced the construction of many tiny cleanrooms for producing DCVax-L, and large cleanrooms and other facilities exist, along with other capabilities required for DCVax-L production that could be contracted for, I believe all are waiting for the EDEN to be available.
I think there is a possibility the Canadians might piggyback on the UK approval. Canada's big, but their population isn't that great, they might concede sharing the Sawston capability, for a short while. As for others, I believe they'll wait for the EDEN.
My thoughts about Canada are more based on their close relationship with England than the actual capability at Sawston, which is really quite limited.
Many years ago I think it was H-P that had a cute commercial that had a caveman trying to sell his stone age printer for millions. H-P asked why anyone would buy them when they could get their ink jet printer far cheaper. His answer was he only had to sell one. It was cute, but it's roughly the same position we're in selling manually made vaccine. The small facility at Sawston is fine for initial UK approval, but it won't ever be expanded on for manual production as long as there is a better way to make the vaccine, even if we must wait some time for it to be approved.
Gary
What I'm really trying to say is if we'd all ignore what the bashers are saying perhaps they'd go away. I know they won't, but if they're being paid for each answer we give, they're making a lot of money. If we ignore them they'll make less.
I don't know that they're paid more for answers to their posts, but I've seen others post on the boiler rooms they work from allege that this is the case.
The actions of the company, be it from yesterday, or 15 years ago are well known by investors here. They're done, they won't change, let's ignore what bashers are saying about them and talk about what we can anticipate in the future.
I can't say what day UK approval will come, or what date approval of the EDEN Unit will be announced, but I strongly believe both will happen. When they've both happened I fully expect that our stock price will be in the $3 to $10 or higher, depending on other news that may accompany them. I cannot speak for others, but personally that will give me something in excess of $1 million in NWBO stock alone. I view that as moderate success. I don't intend to sell at that point, but I believe that by that time on a percentage basis I'll have greater gains than most of the investors I know who've been in stocks like NVDA and TSLA.
I don't know how long it may be before NWBO is in double, and eventually triple digits, but it does have that much potential, if it's not bought out. Just give it time.
Gary
We need some fresh material. It seems like the bashers not satisfied to discuss how long it's taking to gain UK approval or get the EDEN authorized for production are reaching back 5, 10 years or longer to find issues they feel they can criticize the company for. I failed to ignore it, but will try to in the future, and I suggest that if the rest of us did, perhaps they'd try to find some new material to write about,
Gary
Out of curiosity, why was the sale of Cognate such a bad thing if it established a relationship with CRL which could result in CRL becoming a CDMO that handles our vaccines in much of the world. This occurred before I had invested in the company, but I believe it was done as a decision to contract for all these services, rather than owning them.
Decades ago IMGN did much the same, building production facilities, then determining they'd prefer to contract out that work, selling off all they'd built with the exception of the small labs that produced trial quantities of drugs they were developing. It's not a bad business model, making money from the work of others.
Gary
When we come into the earth we owe nothing. During our lives we tend to take on things like mortgages, car loans, credit card debt., etc. Few probably die with no bills that must be paid, if they have less money in the banks, savings, etc they might be considered in debt.
Is a country that different from an individual? Sure they spend more money than they bring in, with taxes, etc. and call it debt. But is it really.
For the individual, they may own real property, or have personal property of value, they may have stock, bonds, etc. In short if all they had was sold for reasonable prices they hopefully could pay off everything they owed.
Is a country that different, here in the US for instance, we still own a tremendous amount of undeveloped acreage in virtually every state, plus all sorts of developed properties. We own vehicles of all sorts from cars to trucks, planes, ships, etc both military and for the use of our officials. The point is, what value is placed on all of this. What about gold in Ft. Knox, etc, how is it valued. I have a feeling that much that we own is valued for what we acquired it for, and probably depreciated downward from there. My point is, are we really in debt, or if all our assets were properly valued, might we actually have been proven as a nation that invested well.
I know it's hard to put a proper value on things like an aircraft carrier that cost $100 billion to build. 30 to 50 years from when they're built they probably will be scrapped, but by then even the scrap might be worth roughly what we paid.
In some cases, something like an aircraft carrier might be considered worthless, but if attacked it might be the difference between winning and losing a battle, or a war. I've had the pleasure of working on a few battleships, a great deal of money was spent bringing them out of mothballs. Frankly I didn't think it a smart move at the time, but on hearing their effectiveness in Vietnam they could have changed the course of the war, but IMHO we weren't fighting to win, so they only deployed there once. Now most of them are being used as Naval Museums. I don't know how they should be valued, but I wouldn't be surprised if their weight in scrap metal isn't worth much more than their original cost to build.
If you've ever been to Honolulu you may have noticed a huge park on the beach right next to the Rainbow Hilton, it's called Ft. DeRussy. Military officers may stay in the hotel there, and much of it is an open park that all may use, but what value is being placed on this massive parcel of land on the beach. I don't know, but suspect it was acquired for under a million, at the time. I doubt very much that it's valued at the billions it would bring if put up for sale.
I don't know the answer, but are we really that deep in debt as a country?
As a real estate investor I, like nearly all others, do depreciate the rental property. In reality, nearly all the properties being depreciated often are actually appreciating. An old friend used to work for an airline in accounting, he indicated that every year they could make, or lose money purely on how they decided to depreciate all their assets. Even their well used aircraft were often worth more when used than what they purchased them for. Things are little different today, though it's been over half a century. Homes built for under $20K back then are selling for a million so they can be knocked down and rebuilt far larger, but their location makes them far more desirable than land that's available for building, or perhaps is govt. owned and not available at all. So what are we really worth?
Gary
I do believe that NWBO can't deliver DCVax-L in quantity when it's approved, but I believe that Advent and CRL can. NWBO's biggest job, right now, is getting the EDEN unit approved and contracts in place to mass produce it. I don't know how close they are to that, but if the estimates of many here that the units should cost $10K to $20K are off by a factor of 5 to 10 times they may cost $100K. In that the first time that unit is used they should see that much, or more back, and it will do 49 more batches in the next year, I think they can work with that.
I don't know who will be making the EDEN units, I believe that St. Gobain's Glass will be making the disposable cassettes that are used with it. I don't know with certainty that CRL will be one of their CDMO's, contractually I believe Advent will be a CDMO unless they're bought out of the contract. In short it's others who'll be making NWBO into a tremendous success.
NWBO has never been the ones who did all the work, they've had contractors of one sort or another involved in practically every aspect of developing their products, putting them through trials, and now gaining approval of them. They contributed to the effort, they supervised the efforts, they found the key people, or companies that could get it done, and with the help of many they got it done.
Remember, NWBO didn't invent the EDEN, they found FlaskWorks, purchased it and have worked with their people to perfect it. I believe the unit today is very much improved on what they purchased, but the company had the right idea and with the support of NWBO they'll gain approval for it to be used in commercial production.
NWBO will grow in size, but I don't believe it intends to ever be the actual producer of the products it's selling, a contractor, or partner, or owner will be who's handling nearly everything, NWBO may be developing and trying new products, working them through the approval process, with the help of contractors, then turning it over to others, and collecting a great deal of the money charged for each person that utilizes their products.
Gary
Thanks Doc,
What you say is true, at least to a degree. They did this for Covid 19, why not for the deadliest and most debilitating diseases. They may hit fewer, but for them they are far worse than Covid.
Gary
I agree and I believe that LP has it planned. I'm as frustrated as anyone here, but I don't blame the company, I mostly blame the regulators as a whole, though the UK is the primary concern here.
To me no new product should take one or two decades from genesis to approval, but most of them do. I'm not saying extreme care shouldn't be taken with meds for headache's, colds, etc. but when it comes to deadly disease like cancer, and especially the deadliest of them like GBM, shouldn't take the time this is taking. Likewise the equipment to make them shouldn't take years to approve. I'm all for the use of Phase 4 trials that verify benefits by tracking all who take a product. I'd be fine with an EUA prior to full approval, allowing patients to pay, and use the product while final approval is coming, I also am fine with confirming trials, as long as the products approved, is being sold and covered by insurance, that way the costs of the trials are easily handled by the sales.
My point is, approval of products intended for the most deadly and debilitating diseases could be advanced far faster with confirmation coming after they became available. I believe people like Dr. Liau knew the benefits of DCVax-L were dramatic a decade or more ago, why couldn't the regulators get that picture, issue an EUA allowing the sale, instead of 1.7 million pages they could have received feedback from tens of thousands of patients who received the vaccine in the decade. All I'm saying is instead of looking at 1.7 million pages they could have the data from tens of thousands of patients. We know the majority of these people would be dead, but I believe it would be clear that they'd have lived much longer than had they been on the SOC, which they had data for. Not only that, when Dr. Liau and her staff learned the benefits of Poly-ICLC it could have been added and benefit increased dramatically.
Of course NWBO would have had difficulty meeting demands until they discovered FlaskWorks, but perhaps it would have been found far sooner and allowed to be used far quicker if an EUA was applied to it as well. If patients are benefitting from its use, what further proof is needed of its effectiveness.
My point is that, if the time required to put life saving products in use is reduced to half of less of what it's taking today, why not do so and track the benefits. If the benefits aren't there the treatment can be removed
I don't know how any of us can know this, unless we're hearing it from the horse's mouth.
Perhaps some here have inside sources, but inspectors can show up anywhere, so I don't know how you'd know the last inspection was done.
I know nothing about it, but of course I believed this would all be over months ago, but then I believe that 150 + 60 = 210, not over 365.
Gary
To be completely honest it was something I heard that she said over 6 years ago, before I purchased my first shares of the stock. I don't believe that her mind about what the company should be worth has done anything but rise. I believe that she, and certainly I, thinks the company will be worth far more in the future than they thought it would be worth 6 or more years ago.
Perhaps one of the shareholders that heard LP's valuation many years ago can say when and what they heard. I believed it back when I invested, and with what we've learned about it's use in patients with other cancers, I believe the potential is far greater today.
LP keeps scrambling for money, I believe that's in big part because she's unwilling to consider a BP getting a substantial position in the company for pennies a share.
LP knows that if a BP got a substantial position in NWBO effectively they would be in control. Why? Because with the investment of a BP at for example 20% ownership of NWBO with a share price in the $5 range would get substantial Institutional ownership. With the support of Institutions the BP could control any shareholders vote, LP could be CEO, but their threat to bring an issue to a shareholder vote would put them in control.
I won't say that LP will never permit this, but not until success is assured and a partner can't prevent or delay it.
Gary
David, I don't believe the company is working on a buyout or partnerships at this time, not at these prices. I believe that LP previously has said that such things would be possible if NWBO was valued at a $20 billion or greater market caps, with our O/S that's around $15 or more a share. LP knows that no company will pay that kind of money until our share price is at least half of that price.
I'm not saying she doesn't speak with interested potential companies, only that she and they know what's being demanded and we're nowhere near the point where serious negotiations can begin.
Discussions of trial that may be run with others are a different matter, as long as no significant equity in NWBO is included in the agreements.
Gary
Steady T, as I understand it, clinical trial material is generally allowed not to be at less than the same quality level of commercial products. I believe that the EDEN is known to be of high quality, the problem is saying it's identical to what's being manually made and approved for both trial and commercial use.
I believe if you're initiating a new trial the EDEN should be authorized as at least being sufficient for the trial. In that no Pivotal trial has ever been established for DCVax-Direct, I would think that the EDEN could be established for where that product would come from.
I'm certainly no expert, just going with what I've been told in the past about such material. On more than one occasion I've seen approvals delayed because the regulator found problems in the production facility, or in the product itself being made in the facility.
I've hated to see approvable products from not being available, sometimes for years, on such technicalities, but I've seen it before.
Gary
I believe that all new trials should be done with the EDEN. While it may not be approved now, by the time the trial is concluded it should be. I would think the regulators would accept that rather then tap the limited capability of making these products manually.
Gary
I would think that EDEN approval would be on a parallel path in the UK, not in the package that's approving the vaccine. The question is, will the UK independently approve the EDEN, or it it being approved multi-nationally so that it can be applied everywhere once approved.
If this isn't the case, once approved in the UK it will still need acceptance with every other regulatory filing.
Gary
If the company had followed all the late filing regulations and their explanations accepted, do you think the shares price would be what it is, and that most investors couldn't buy shares?
Gary
I think that their next report will be the Annual Report- 10K, they get an extra month so it should be out about the first week in March.
Gary
I'd like to know what Phase people here believe will be applied for in restarting DCVax-Direct in trials. Do they have sufficient data to begin in Phase 3. Is Direct precisely the same as previously used.
I believe that a case can be made for using the EDEN Unit for making Direct, does anyone agree with me.
Gary
When I use your link I get a list of their hospitals, not drugs, am I doing something wrong, or is there a problem with the link.
Thanks,
Gary
At closing today I believed we closed down by $.0012, that's what I saw on CNBC, it's what I saw here until minutes ago, when I did a refresh on the site. I brought up new posts and the quote figure didn't change. Is it just me, or are others seeing the same sort of quote delays from normally reliable quote sites.
I normally keep the CNBC quote site showing on my phone, anyone care to suggest a more reliable site.
Thanks,
Gary
Ex, I've not been a big fan of the FDA, but it does seem like they meet their PDUFA dates most of the time, and reschedule when they can't. Why in your opinion do most of the other similar agencies fail to come close to meeting their guidance most of the time. I grant you, other agencies don't create something as firm as the PDUFA date, but when a 5 or 7 month goal extends to over a year I'd think something official should be provided for investors.
If the other agencies did establish something similar to our PDUFA date, then at least they could officially reschedule their target date rather than keeping everyone in limbo.
I do believe we'd have gotten a no long ago if that was going to be their answer. What I hope is happening is providing them evidence for a more open label, if that's correct, the delay could be very worthwhile.
Gary
I've been doing much the same, but didn't restrict the numbers. When it came time to vote the shares, they apparently were transparent in permitting me to vote all my shares and returning them to the program.
Anyone who's using margin can have their shares lent and receive nothing. I see no reason not to do it. I had absolutely no problem selling my higher priced shares for a tax loss which were lent shares, they immediately moved the lower priced shares, which hadn't been lent, so my income from the shares remained constant.
While I don't have any margin at this time, as I understand it, I can be in the program, still use margin if I choose, and be paid for lent shares. If I wasn't in the program, and used margin, my shares could be lent, and I'd get nothing.
As I see it, when the time is right I can help facilitate a short squeeze by putting in a sell order at much higher prices that wouldn't permit the shares to be in the program, and add to the squeeze on shorts to cover. Fidelity, unfortunately, doesn't allow a substantially higher sale order, but I believe that once we're selling at over $1 they'll allow a higher price. By the time we reach say $5 I don't know that they won't allow say $25 or even $50.
Frankly I believe the biggest short position isn't on properly borrowed shares, I believe that the MM's, who can legally be short, though they're not supposed to maintain such positions, are actually maintaining substantial short positions, possibly moving the positions from one MM to another to avoid holding such positions for extensive periods of time.
I believe that if discovery is done on the 7 MM's this could become apparent, if I'm right. If it did, I suspect the SEC would be interested in such manipulation.
Again, this is JMHO, other stocks I hold are also being lent, it's not just an NWBO thing, but NWBO is bringing in the greatest gain.
Gary
A question I'd ask about collaboration, if requested, could NWBO provide them with data that's yet to be presented for peer review? If all available data, including all compassionate use cases, is made available, could it lead to a much broader label?
I certainly don't know what's proper in such circumstances, but if an official agency asks for something, I would think that companies wouldn't withhold it.
Gary
I think the moderators should sticky this post, or the Law Review document within it.
A great deal of what's happened to NWBO has been exposed in detail by this and the Bamboo lounge article. Hopefully this is the precursor to the actual legal action occurring, and the UK regulators acting as well.
Gary
I was happy to see this here, I also got it on my email and would have posted it if it hadn't already been done. To my knowledge, this is the first public acknowledgement of what's happening. Has anyone seen anything additional?
If the author's correct, the Govts. looking at what's happening and perhaps what began as a civil suit could also lead to criminal charges. I believe it's all more reason that the 7 MM's will settle before they ever have to actually open their books.
I'd be happy with the settlement, but even happier if regardless of how the civil suit ends the SEC recognizes that it warrants further study, and it results in criminal charges.
Gary
I'd like to ask those who've worked in such places, once the EDEN becomes available, how many people should be needed to keep a given number of EDEN units operating essentially full time?
I'm no expert, but I'd think that if the EDEN units are being monitored by one, or more, computers, either on or off site, it would be the computers that notified operators of the proper time to remove the disposable cassette for processing. On it's removal, whatever maintenance is required would be done, and a new cassette would be loaded. What I don't know is how critical timing is. When a batch of vaccine is complete, is it's removal from the EDEN something that must be done in minutes, or hours, or a day or more.
My point is, can one person working one shift a day keep say 50 EDEN units functioning properly, or does it take more people and 24/7 coverage. I don't know, but I'd suspect that someone manning the entire facility 24/7 is required, but I don't know how many EDEN's will be in one cleanroom or if that cleanroom must be manned 24/7 or if a computer notifies the operator that EDEN No. XX in cleanroom XXX is ready for processing, and the operator has substantial time in which to service that unit.
Once the EDEN is available and significant numbers are installed at Advent, the question may be, is manual production of DCVax-L eliminated. If it is, and if other uses of those cleanrooms don't keep them fully occupied, is the staff working there sufficient to keep all the EDEN's working at capacity, and is it possible that staffing levels will go down as production of DCVax-L rises substantially.
As I've said, I know nothing about it, clearly there are other jobs that require substantial handling to deal with the raw materials that go into the cassette and the vaccine produced in it, and I'd expect those numbers to increase. I was speaking in terms of the numbers who must be working in the cleanrooms to load cassettes, monitor them, and handle the vaccine in the cleanroom environment. Should the EDEN units result in substantial growth in employment at Advent, or just require many currently making vaccine manually to transition to making far more of it utilizing the EDEN's.
Gary