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I certainly don't know, but believe that the company has enough positive information to file and justify an approval that's either conditioned on a confirming trial, or by having the outcome of all uses reported in a Phase 4 to confirm the benefits and verify that no unknown detrimental problems are occurring. If the drug's also approved for AD or other diseases, they too could be part of the Phase 4, or it could be limited to only those treated for Rett's.
Personally I believe that the whole approval process ought to be simplified, costs and times reduced, but all approvals followed by Phase 4's that are easily inputted by the prescribing Dr. unless problems are noted, then they need to provide further information. If the FDA or others see specific problems developing, depending on the problem, they need to take action that may be as simple as a label change, or as serious as removing it from the market. Such actions should eliminate the possibility of drugmakers paying off patients to hide adverse reactions.
Gary
Thanks, if their facilities have already been inspected for commercial production they'll need nothing more, if not they'll probably have no problem, but it's a formality that has to be dealt with.
The key is getting the filings in at the regulators. I'm no expert, but believe that over 90% of what's filed is identical, so after making the first filing it's about making the necessary modifications to make the other filings. The question is whether you wait for the first approval before filing for others, or not.
Gary
Other companies I follow have scheduled for Monday, so I suspect they have at least that long without filing for an extension. In the past when they missed the date they did file for the extensions, which are permitted pretty much automatically.
I've seen pink companies that failed to file for years, then come current and be sold as shells. I'm not suggesting anything like that, but the SEC frankly doesn't seem to care that much about what companies do. Frankly I don't believe that we'd be discussing things like spoofing, naked shorts, etc. if the SEC were more rigorous about doing their job. I frankly don't know why we have certain securities laws if the only time they're to be enforced the SEC announces they intend to enforce them. If a law isn't going to be enforced, why have the law.
I say that, but I'd hate it if speeding laws were enforced on free flowing freeways. If you drive at, or even 10 mph over the posted speed limits when traffic is free flowing you could either cause an accident, or perhaps have a shot taken at you or at least given the finger, by all the others driving at 15 to 25 mph above the speed limits who're passing you. I've never gotten a speeding ticket when driving at the speed of traffic, but at 5 a.m. when I'm nearly the only one on the freeway, then it's happened, many years ago.
Gary
In the UK a commercial production facility has to be approved before an MAA can be submitted. I'm uncertain of the other regulators, but know in the case of the FDA the inspection of the production facility is part of the NDA or BLA submission and an successful inspection must occur before approval.
Gary
If not they will file for the delay, I suspect that we will see one or the other by the close tomorrow.
Gary
I suspect that we'll get the 10-K after the bell today. I rounded out my position so if I'm right, and if there is something positive within it, I'd have all the shares I intend to get, though I have said that before. I actually had to raise my limit order a few times to get all the shares I wanted, but only by hundredths of a dollar.
Of course the company can request to delay the 10-K and I believe they can get up to two weeks, but they've been on time on most of their recent filings, so I think they'll continue to be so.
Gary
I tend to agree with Xena, but I do believe the FDA is improving. Many companies are going for approval by other regulators first as they work faster and are less likely to balk at some minor issue that can be resolved in discussions. BP's have a lot of influence at the FDA as they pay them, their drugs seem to have fewer problems in gaining approval, but of course they also have far more experience in applying. Sadly most of the new innovation is coming from small biotechs and research institutions, but BP's are acquiring many of the biggest products in their pipeline rather than developing newer products themselves.
Gary
It may be correct. Just remember that if the company wished to delay, it is easy to do.
Gary
Do you know how well our data compares with the data being cited here:
https://finance.yahoo.com/news/minerva-neurosciences-receives-complete-response-130000303.html
They got the dreaded CRL.
For a Phase 2 to gain approval it must have been done with pivotal quality material, do you know that to be the case. If it is, it could be referred to as a Registrational Phase 2.
Personally I'd like to see the FDA do more conditional approvals, either requiring a confirming trial, or for all receiving the drug reporting results in a Phase 4, perhaps even both until they're satisfied with a benefit. All to often tiny companies can't afford the further testing the FDA requires and good drugs are either abandoned, or sold to a BP dirt cheaply.
Gary
I think if someone can separate all the accelerated pathway products we'll find that the UK is largely out on time, or early. Our FDA is acting by or before the PDUFA date most of the time as well. It's my belief that most early decisions are approvals, when they go right down to the wire it can go either way, and often is a CRL.
March is the very earliest I believe the UK could act, but in April or May it could happen any day. I'm not suggesting early March is possible, only very late in the month at the earliest. While I certainly feel good about an approval, that doesn't mean the UK or anyone else may not want to see additional confirmatory trials. I would hope that all future trials can add the drug combinations which the clinicians have shown to achieve the greatest results in early stage trials.
The sooner the EDEN unit is ready for commercial production the sooner we'll apply to the other regulators IMHO.
Gary
Are we mixing the time to approval between products getting priority review and those that don't get it. If all priority reviewed products are averaging 200 days or more, that speaks for itself, but if we're mixing products, 200 days is probably a good average.
Our FDA is much the same, if you get priority review, your PDUFA date is 6 months after the BLA/NDA is accepted, if not it's one year. The FDA normally acts by the PDUFA date, but sometimes their action is to delay the date for a variety of reasons.
To my knowledge, the UK doesn't put their target date on a public calendar, they establish their target, and investors can figure it out for themselves. I'm uncertain, but believe it's true of the others as well, the FDA states their deadline, the others say what their targets are. None of them are always on time and have no delays.
Gary
I agree, but it's covid that convinced companies that many could work successfully from home and much office space is being abandoned. In New York City they ran a 60 Minute story on it, much of the office space may be turned into living space. What Covid has proven is that people can be more productive when trusted to work from home, at least a good part of the work week. When needed they get together in a conference room, if not by Zoom conference. The point is, many companies don't need nearly the real estate they had to get as much, or even more work done.
Look at NWBO, as I understand it, many key people are not working from the main office, some not even in the country. Certainly people would have to work where DCVax-L production is taking place, but much of the rest can be done from anywhere.
Gary
I agree with you, I believe that hydrogen will play a big part in the future in certain things, but not as a replacement for gasolene in cars. Boats, ships, trucks, trains and aircraft may be hydrogen powered, either with fuel cells, HCE's, etc. but not in many cars. I happen to have a hydrogen fuel station just blocks from my house, but there are so few of them that even in California, there is much of the state I can't get to. No other state has near what CA has.
I believe the infrastructure will be built that will have hydrogen in airports, harbors, and at sufficient truck stops to cover long hauling trucks, but not everywhere needed for cars to be able to travel freely.
Gary
HCE is not superior to electric, it still produces NOx, but it is far superior to petroleum CE. With improvements in batteries I don't think that HCE will be utilized that much.
Gary
I freely respond to you all the time, in this case I read many posts and simply didn't go back to find the first mentioning the AMGN construction. It wasn't intended to be criticism of what you're saying, but similar posts have been made about Merck and others building new facilities and I believe all are an overreach about why they're being built.
Building facilities with hundreds of thousands of sq. ft. with no assurance of what it will house makes little sense, but it does happen. Right now the Chinese have built entire cities that go unoccupied, and much commercial real estate is vacant because of the changes that Covid has brought about. I just don't believe Merck, Amgen, etc. are building without some solid indication that there is a use for their facilities.
Gary
When I hear about AMGN, or anyone else, building a massive manufacturing plant, the last thing in the world I think should be assumed is that it's for producing DCVax-L. I believe the facility for producing products by the millions of doses would be different from one designed to product DCVax-L, not that it can't be adapted, but with nothing in place between AMGN and NWBO I've got to believe that AMGN already has products in mind for production at their new facility.
I have no doubt that one or more substantial facilities will be needed for DCVax-L production in time, it's known that CRL has some capability in the Memphis facility they purchased, but we don't know if that facility is already being fully utilized for other products. The EDEN unit provides a great deal of flexibility in how it may be deployed. Thousands of them could be installed in a single facility, or they could be spread out individually, in tens, hundreds, or thousands to installations with cleanrooms and the cryogenic capability needed to properly handle the vaccine, etc.
I don't believe that NWBO will ever sell the EDEN unit, I believe they'll be leased and that NWBO will be fully responsible for maintenance and any upgrades to the unit. If I'm correct about this, NWBO would have the flexibility of having all the EDEN units being utilized in one or two major CDMO's, or in many smaller places with similar capability. To me, the complexity of shipping tumors, etc all over the world, making the vaccine, and sending it out as needed is far greater if only one or two manufacturing and storage sites are used worldwide, than if smaller such sites are more geographically distributed around the world. It's certainly not that difficult to ship cryogenically almost anywhere in the world, but clearly the task is easier if it's localized.
In the beginning I think all the vaccine may come from one or two sites, but as demand increases I believe opening additional sites geographically rather than greatly enlarging one or two sites would make sense, and it would simplify worldwide delivery.
Gary
Does it really matter precisely what Sawston can make. Worldwide demand is going to be substantially greater, additional production will come from the expansion of Sawston and bringing other resources on line. Whether it is CRL or others, the demand will be met by building up the suppliers capable of making the vaccine.
Gary
I wasn't an investor at the time I believe she indicated what she believed would be an acceptable offer. I do however believe that since then much has been learned about DCVAX and I think that the price would be substantially higher today.
I don't believe back then they were convinced that the vaccine was tumor agnostic and I don't think they knew of the increase in T cells that explains why the vaccine was so effective.
Gary
From what I've read there are a few things that could turn things around rapidly, but I have no idea when they'll occur, but I believe they will occur. One is the publication of a peer reviewed article in a Journal, but I have no idea which one. My prior experience is that Journal's take much longer than most investors think. The others have to do with filing for approval, the timing for that is purely up to the company, but once again it often takes longer to do than most investors think, and sometimes much longer than companies think they can do them.
As to feedback from the FDA or other regulators, most companies say nothing unless it's something they must say. If in discussions with the FDA they're told that additional trials are required for RETT's, they'd announce new trials. If on the other hand they were encouraged to file an NDA, I doubt if they'd say the FDA advised doing so, they might say they're doing it, or wait and announce they'd filed. The fact that they've announced the intent to file an MAA would seem to indicate that they'd announce another if it's planned, if it is, it's very probably coming after successful discussions with one or more of the regulators.
Gary
I'd agree with what you're saying if the supply is plentiful. The question might be, with UK approval and a demand by British citizens that exceeds the available supply, can someone who doesn't have citizenship purchase DCVax-L at any price or won't it be available until they can meet all their own needs. Of course I may be wrong about this, but I would think that many have already banked their surgically removed tumors in hope that the vaccine would be available in time, assuming many of them are still candidates for the vaccine I would think it would take a great deal of time, and probably the approval of the EDEN units before excess supply exists that can be sold to others.
I don't believe that Sawston is fully built out for manual production. If they believe the EDEN will be available in a reasonable amount of time, I think they'd build some much larger cleanrooms intended only for the EDEN rather than packing them 12 to a small cleanroom. I don't know this is the case, nor do I know if our small cleanrooms have been designed to be easily converted into larger cleanrooms by removing walls that were designed to be removed.
Once we have UK approval I would hope that new trials would be underway shortly thereafter. I believe the EDEN would be specified for making the vaccine for any new trials and that too would help in getting it approved for commercial production. I would hope that UCLA also was permitted to use the EDEN in new trials as well.
Gary
Thanks Chiugray, imagine our potential with off label use once it is sufficiently proven that insurance will pay for it.
Gary
In looking at the PR on the production manually at Sawston, it appears to me that they could build 20 suites similar to the one discussed here at Sawston.
https://nwbio.com/northwest-biotherapeutics-announces-mhra-approval-of-license-for-gmp-manufacturing-at-sawston-uk-facility/
If you take the more optimistic figure of 500 batches a year, that would be 10,000 batches annually if Sawston were built out totally for manual production. If ten EDEN's can be installed in the space of on single manual cleanroom, that would give Sawston 100,000 batches a year as their full capacity if built out the way the initial suite was. I would think that if EDEN is approved before the Sawston facility is built out, fewer but larger cleanrooms would be built that could increase the capacity, but it's doubtful without expanding the total sq. ft. available if Sawston's capacity would exceed perhaps 150,000 batches a year. While this is an impressive number, I don't believe it would meet worldwide demand in GBM alone, and certainly couldn't touch the demand if tumor agnostic use was developing rapidly. Without the EDEN, I don't see how NWBO could possibly approach the additional regulators without substantial additional manual manufacturing capability.
Please correct me if there is something wrong with what I'm saying, but if I'm right, I continue in my belief that the EDEN is the key to filing with the other regulators as it would be cost prohibitive to build a major new complex of tiny cleanrooms with plans of replacing it in a matter of months with EDEN production that could be done in larger and less expensive cleanrooms a matter of months later. If their never was an EDEN, or anything like it was conceived of, they'd have built the tiny cleanrooms, and it would be a very profitable venture, but their is an EDEN and it will be worth waiting for.
Gary
Biosect,
I believe it's possible that NWBO neither spend, or receives any money in the special program, but the agreement between them and Advent may be that at least some percentage of what's received is spent in finishing additional production suites at Sawston. I'm not saying this is the case, but people looking at prior quarterlies haven't seen substantial funds coming in from the special program which is believed to have dosed hundreds of people over the years it's been in place.
It's unclear to me whether the special program will cease to exist, or not, once we have UK approval. As I see it, it would still be a way for citizens from outside the UK to acquire DCVax-L. Once approved for the UK, I don't know if non citizens can acquire it in their medical system.
Gary
As a newer investor in the company, I know the company has spoken of a peer reviewed Journal publication. My question is, do the investors here have a feeling for which Journal will publish the article. At NWBO there was a great deal of speculation and I don't believe even one investor thought JAMA Oncology, but that's who published. All were thrilled with it, but most were guessing NEJM, Lancet, etc.
No telling how many Journals a submission is made with, or how many times revisions are required, or how long publication is being held up because some key person isn't available and publication won't happen without that reviewers approval. In NWBO's case it was discussed for many months, probably nearly a year before it happened, but the key is, it happened. I believe the company does get a few days notice, and certain Journals are available on-line before the hard copy is out, but the point is, you never know how long it will take.
At least drug applications are more predictable. I believe that Anavex can justify priority review with all the regulators. In the FDA that means a PDUFA date being established 6 months after they accept the NDA. In the UK, they try to make a decision 5 months after the submission date. I believe the others are all in the 6 month or less range. Nothing is guaranteed, all the regulators can ask for something else, or just move the date, but at least you have a target. If the FDA's approving it may well come at anytime after about 4 months, but denials generally come near or at the PDUFA date.
Gary
When you do get a meeting with the FDA, or other regulator, it may be more important who you get the meeting with. A meeting with Dr. Padzur's staff may prove a hindrance if they don't check with the good Dr. on what they advise. It's been decades, but I feel certain that Genentech had such a meeting in designing a registrational Phase 2 trial for Kadcyla. When they submitted for approval, Dr. Padzur simply said he didn't like the trial format, and he refused to review their filing. The approval was delayed by years until a Phase 3 trial he agreed with was completed and submitted. I believe that Dr. Padzur was sending a message to his staff as much as to Genentech, don't make commitments without checking with me. It's rather like checking with the IRS, taking their advice then going to tax court and finding it was wrong.
I believe the FDA has improved some in all those decades, but it's still important to get to the right people and reach agreements before making the formal submission, best to wait until that occurs. I certainly don't know what precisely went wrong, but NWBO made the mistake of saying they would submit to the UK by a date certain. After that they backed off twice before actually submitting. They would have been far better off if they hadn't been so precise about when they'd file as credibility was lost when they didn't. Saying you intend to file in a given quarter isn't bad if you believe you'll file early in the quarter, but if it's late in the quarter, better to say the next quarter, and be early. Sure, people really don't like weasel-wording, but it's better than being more precise and failing to meet your commitment.
Gary
Kap,
I really don't worry about the bashers influencing new investors, we haven't had the sort of news that would send many new investors our way, but if they do seriously take a look, they'll find the serious information, like the peer reviewed Journal, and disregard the bashers that can be found on practically any site on I-H and other chat sites. If that doesn't get them in now, don't worry about it. When the company has real news, like the approval in the UK, they'll realize the bashing was just that, and they'll be buying in at substantially higher prices. That's fine with me.
Good news that's undeniable isn't that far away, those who can see it coming are in or will be getting in soon, those who don't will be in after the news. Institutions will be in big time, but not till they anticipate the share price rising through the $5 or greater level required by their charters. It all will be coming in the future.
I certainly don't know, but suspect that we have many here who hold several thousand shares, or more, here. Each investor here would have some figure at which they'd have $1 million worth of NWBO stock. Some would be there at $1 or $2, personally it's a little over $3 for me. Regardless of your figure, I suspect that most believe that $1 million figure is possible for you this year, I certainly do. Now let's take it a few steps further, who doesn't believe that in the following years it won't be up that much or more.
I know many would like to rush into a buyout, but who really would mind having a million dollars or more in their account every year for the foreseeable future. I believe that we have that sort of potential, and some years it just might be $5, $10 or more millions, not just $1. We have that sort of potential, why push to be bought out.
Gary
No company I have ever followed has ever discussed what was said in meetings with any of the regulators. Missling is no different than any of the others.
Gary
Frankly the way investors speak about executives before clinical success and the way teenagers think about their parents is much the same, they're all fools. With drug approvals in biotechs, and a few year of growth for kids, it's amazing how smart they've become. I can't say how many companies I've seen criticize management when approvals are taking longer than investors thought they would, but when the approval come in, the executive become the toast of the town.
Gary
Beartrap, I believe you're precisely on the money and in a few years the company will have a major choice to make. Do they wish to be bought out at say twice the current price, I'll presume that to be $50 or more a share, or do they wish to grow into a giant in biotech, perhaps the next Amgen, etc.
In three years time it's doubtful that new trials started this or next year can be near conclusion, but it's very possible that sufficient data has been seen to know that both DCVax-L is truly tumor agnostic, and is being used frequently off label in many cancers, and that DCVax-Direct will be approved as a tumor agnostic product. By that time the investment community will all know about NWBO and double the current price might well be near or at triple digits. By that time it's very possible that we'll have a BP equity partner and that would be the most likely to consider a buyout, but the price tag could easily be $100 billion or more.
Right now there are two keys IMHO, UK approval and acceptance of the EDEN unit for commercial production. I believe it's possible for submissions to go to the other regulators, including the FDA, shortly prior to EDEN acceptance, but the company needs to be certain the acceptance will fall into the timeframe that their applications for approval are being considered.
I know that some investors believe we could proceed with manual production methods alone, perhaps it's possible if we had a contract with CRL to devote a massive number of cleanrooms to such production. I believe that CRL will play a big part in producing DCVax-L in the future, but it will be with the EDEN. I believe the only way we'd go to manual production worldwide would be if acceptance of the EDEN was deemed to be years away. To my way of thinking, UK acceptance by mid-year and others not until early next year is an acceptable scenario, and I believe it's one that will have the EDEN unit doing the commercial production.
Gary
Sorry, wrong board.
a
In the world of drones, so many types exist that we really can't say what compares with what. Some drones are the size of small aircraft and fly on and off aircraft carriers just like manned aircraft, some are as tiny as a ladybug, or smaller. My point is that our drone does certain things, and does it well. I believe the technology involved could be adaptable to both larger, and smaller drones that have similar capabilities. I don't believe that our drone is competing with those that are weapon systems from major defense contractors, but if the DOD likes what they're seeing, a major defense contractor may want to either partner with, or acquire the company. Either way, investors would come out very well.
I would suspect that with the right payload, our drone could spot incoming drones or other weapons over a substantial perimeter in time for action to be taken to prevent damage. Whether it's at sea, preventing an attack on a ship, or scanning an area around a military base, or surveying a border for approaching aliens. My point is, with just a few drones 24/7 protection could be established over a substantial area and with a variety of payloads. I doubt our unit would carry offensive weapons, but it would permit them to be targeted right on whatever they're tracking.
Gary
I agree with you. If the company is bought out, it will be to someone who guarantees that the science they've developed continues to move forward. It would not surprise me if they became a wholly owned subsidiary of the buyer, and if both LP and Dr. Liau were assured of remaining involved for years, or perhaps as long as they wished to be.
Frankly I believe that LP would prefer a partnership to a buyout, but of course I could be wrong about that. It would also be very possible that she'll do nothing for at least a year or two, by then she could have DCVax-L approved all over the world and DCVax-Direct well into trials. A buyout at that time would not only bring in far more, but the success of the vaccines to date would assure that their use would continue growing ever more rapidly with the support of the buyer. It's very possible that they buyer would also partner with NWBO at an earlier stage of the companies development, perhaps as early as just after the initial approval of the vaccine.
We ought to be about a week from when the Annual Report is issued, it's hard to say if anything really new will be found in it, or not, but it at least gives the company an opportunity to provide some new guidance. We'll see if they take advantage of the opportunity.
Gary
You could be right, but I believe that we can submit the BLA without having a BP partner, in fact I don't see it as mandatory, but desirable.
I believe that CRL could be a partner, who're not considered a BP, and they could bring in billions and be responsible for distribution everywhere in the world except the UK where Advent would cover.
Gary
I've listened to the webcast and looked through the quarterly, it looks to me like things are advancing nicely. Apparently more was anticipated as the stock was down dramatically after hours in reacting to the quarterly. Sometimes it's foolish to think that sales growth will simply go through the roof instantaneously. $1 billion in earnings should be worth a market cap in the $10 to $30 billion range, if it takes a few years to get there as I see it, the company is moving in the right direction.
Gary
Kab, the agreements between NWBO and Advent/CRL could be structured in so many different ways that it's impossible to say what they'll be. As I see it they will make, store, and supply as needed every batch of vaccine that's ordered. NWBO could either be paid for these rights, or pay for them, if they're paid Advent/CRL will make more from each batch, if they pay, NWBO will receive more, the point is, it's a balance, NWBO will be in charge, but they can structure these agreements in the manner they choose.
I suspect that the framework for what will happen has already been agreed upon, but it cannot be implemented until the EDEN has been approved for commercial manufacturing. I don't believe the EDEN will ever be sold, it will be leased and NWBO will be responsible for its maintenance and any updates. Software should track every disposable cassette so the company is tracking every new vial of the vaccine that's manufactured by either of the contractors.
I certainly believe that the lease of each EDEN unit will bring in some payment to the company, but as long as demand for the vaccine grows, the cost of the lease will be recaptured after just a few doses have been made with it, and paid for. The production of EDEN's ought to be either profitable, or no worse than cash neutral to NWBO. Production of the vaccine will clearly be profitable.
My point is that NWBO can be very flexible in how these things are developed, they certainly could still go other directions, perhaps with a BP, but I believe they'll do it with Advent and CRL at least in the beginning. As for monetary concerns, once the share price is in dollars, generating hundreds of millions through stock dilution isn't nearly the problem it is today.
Gary
Frankly the company hasn't yet given the investment community a reason to want to buy NWBO stock. We've put two and two together and see the reason, but the greater investment public has never heard of NWBO. This condition won't remain forever, at some point we'll get major media coverage and suddenly almost everyone will hear about NWBO. I wish I could say when it will happen. It's possible the article in Nature will touch it off any day, or it may take the UK approval. I really don't know, but at some point the fact that we have a vaccine that potentially could improve the treatment of nearly all solid tumors will be heard by the investment public.
All of us investing, or bashing here know nearly everything the company does or says, but others simply do not. I've certainly told many who haven't gotten in. Why? They simply don't believe in investing in stocks selling this low. I'll practically guarantee that when the stock is $5 or more and trading on a major exchange they'll ask me, was NWBO the stock you were telling me about when it was $.50. They'll be buying then, while we'll already have a ten banger.
I just don't believe that you can keep the message down, but I don't know what will bring it out. Nature by itself won't, but if one of the major network sees the story in Nature and puts it on one of their major news outlets, like 60 Minutes, or even in the national nightly news, that could certainly be a triggering event. Once triggered, it won't stop. The more investors look into NWBO the more they'll want to have a piece of the stock, perhaps to the point that it takes us to a market cap that really can't be justified.
I'll be the first to say that by itself DCVax-L isn't curative, but with the right combination of therapeutics it may be. The thing I believe can be said is that with essentially all solid cancers it has the potential of improving the outcome for the patient. Certainly in some patients it will be better than others, but we have a vaccine that may make the difference between a cure, or not, but at this point it's not yet possible to say who will get the maximum benefit.
I'm certainly no medical expert, but it's not been that many years that we've learned about T-cells, CAR-T, etc. Now it seems like we're learning about many types of T-cells with some companies developing new therapies with certain T-cells. What we know is that our vaccine expands the T-cells that are naturally fighting the cancer in the patient, not some selected T-cell that a company picked. Can you imagine a network asking the question, what's the best way to fight cancer, is it specific targets selected by a company, or is it to use the cancer to make a vaccine that identifies all that must be fought in the cancer. I believe the answer will become obvious.
Gary
Kab,
I suspect that deals that formalize CRL and Advent as being the primary supplier of the vaccine worldwide and leasees of the EDEN units to do so are ready to be signed, sealed and delivered, but await one singular event, the acceptance of the EDEN unit to commercially make the vaccine. Certainly I could be wrong about this, but I believe that's how the company is planning to operate.
Sawston already can make the commercial vaccine manually, but capacity is quite limited and while some may disagree, I don't believe it sufficient to satisfy FDA requirements. I'm frankly uncertain if European and/or Canadian requirement could be met with Sawston as is, nor do I know if language already exists with Advent on using the EDEN when they're approved for use.
Hopefully in either the Annual Report or Annual Meeting we'll get further guidance on this, the recent announcement on the EDEN is a positive, but still leaves us unsure of how much longer it will take. If I'm wrong, if sufficient suites of cleanrooms would permit FDA acceptance of the facility, then an FDA filing could be made at any time, likewise the other regulators. If I'm right, all but the UK may await EDEN acceptance.
Gary
Smitty, I know many disagree with me, I'll agree with you that the BLA is near completion, but production will require the EDEN and until it's within a matter of months of being approved they'll not file. When the EDEN is ready, I believe it will be leased and licensed to both Advent and CRL who'll be contracted to do nearly all the work related to distributing the vaccine all over the world as new countries are added to the list of those approving the vaccine.
It really won't take that much larger a staff to operate this way. The company itself will largely be involved with new trials and products while the other work will be done with contractors.
Gary
ATL, you are right on the money. Furthermore NWBO has contracted for so much of what has been done to present, there is no reason why they can't continue operating in that way.
I still believe that CRL could play a big part in their future and could take on much of the tasks unless a buyout ends everything.
Gary
While I'm new to this company, investors in NWBO have had a few similar situations. The submission was known to have been made, but the journal was not identified. We waited many months and finally it came up in JAMA Oncology, a publication that none of us had guessed at. The draft of anything article that should appear in Nature was seen many months ago, it still hasn't published, and no one seems to know when it will be. My point is don't disparage, it will happen in time and I believe it's correct that the company will learn of it slightly before it comes out, but probably can't say anything until it's out, but they can be prepared to discuss it then.
Filing for approval is a different matter, the company has at least some control over that. Contractors may be used for certain aspects of it, and they can't always control them precisely, but they have some control, and if the application is undergoing rolling review, they have an opportunity to fix anything the regulator suggests changing. I don't know if they've ever revealed doing a rolling review, but as I understand it, corporations are not supposed to announce that they're in a rolling review.
Gary