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I'm of the understanding that an article has been written and is in peer review. It could appear in a number of different medical journals, so I have no idea which journal is subjecting it to peer review. My experience with NWBO's telling me this could take many months. I have no idea if the submission was substantially reworked, or how many revisions were submitted. No one speaks about that, nor do we ever know what's holding up publishing. It happens and nothing the company can do will make it happen any quicker.
The journal article has probably been prepared by all the clinicians involved in the trial, that would include a company representative, but is largely independent clinicians. Some time is no doubt spent in getting them to agree with what's in the entire manuscript. I would suspect if a peer reviewer requests a change, that too would be passed through all authors before it's resubmitted. In short, it simply takes time, like practically everything else when it comes to delivering a new drug to the market.
To me it's a crime, but if a drug has spectacular results in Phase 1 against the deadliest of diseases, it will still take 5 to 10 years or longer before approval is granted. From genesis to approval most products probably take 20 years or longer. The right to try or compassionate use of most drugs are rarely used because companies are unwilling to give up the information required to be paid for the drug. If the drug makers and regulators agreed to a fair price for use of the experimental products going into the trials, without the company giving up proprietary information, many drugs could be used and proven well before actual approval is granted. NWBO did have substantial numbers of patients treated in the UK where it was available for a substantial price, but only in the UK. Patients from elsewhere in the world came to the UK to get the vaccine made there from their cancer.
Gary
The ball is in Posner's court, not LP. It's Posner and her firm that brought the case, with NWBO supporting their effort, but win, or lose, this is Posner battling for us, and the commission they'll earn by winning. Too much emphasis is being paid to the suit, unless a settlement comes in short term, by the time the suit is settled NWBO should already be very successful and this will give the company the money to do more without either dilution or waiting for more revenue to come in. Investors won't be complaining about dilutive financing once the share price is in excess of $5, and it will be if it goes to trial, but perhaps not if we settle in the near term. If Posner fails to convince the Judge that the case is valid, she and her associates will have done a great deal of work for nothing. She's been very successful in what she does, I believe this will be another one of her successes.
Gary
I'm now in, came up to the ask as sellers appeared unwilling to even give $.001, it's just not worth fighting over a few dollars and failing to get the stock today. No one knows if they'll do an announcement tomorrow, before the bell, and change everything. I decided to get in today and now I'm in.
I know very little about the way batteries are made today, but I gather it would be far easier to incorporate our technology into battery manufacture than producing solid state batteries. If that's the case, I'd hope that we'd see cars with our batteries in them in the next year or two.
Gary
I'm trying to buy in, raise my bid to .001 below the ask but sellers don't seem to be willing to budge. Hopefully someone will before the day ends.
After reading more about the advances the company's making I do think that they stand a good chance of developing the next generation of batteries for one or more of the major automakers. While I'd be very happy if it's Ford, and hope that whoever it is they do the manufacturing of the batteries in the US, but regardless, if our batteries are found in cars from one or more of the major automakers, you'll be able to move the decimal point a couple places to the right.
Gary
I'm trying to buy in, raise my bid to .001 below the ask but sellers don't seem to be willing to budge. Hopefully someone will before the day ends.
After reading more about the advances the company's making I do think that they stand a good chance of developing the next generation of batteries for one or more of the major automakers. While I'd be very happy if it's Ford, and hope that whoever it is they do the manufacturing of the batteries in the US, but regardless, if our batteries are found in cars from one or more of the major automakers, you'll be able to move the decimal point a couple places to the right.
Gary
I missed the conference, may listen to the replay later, however it's not really about what the company says. It is about what the company does. Filing with one or more of the regulators is the next big step the company need to achieve, do that and then gain approval and we'll be in great shape. Fail to do that and we can continue to move up and down on words, but no big gains can be made on words alone. Filing is a huge effort, but that's what needs to come. Give the company the time it needs, but it must be done and the company needs to provide guidance on the progress they're making toward doing it.
Gary
George, I do have a sizable position for just getting started in the stock. In terms of production, while they're certainly highly qualified CDMO's, have their manufacturing process for the drug already been approved by the regulators. If not, I'm sure they'll have little trouble, but the regulators often find little things they'd like to change.
I've only recently finally had my solar system approved, it's taken many months. In the end, far more grounding was required than I'm told would have previously been required. Personally I don't understand all that was demanded, like running a line from where my water line enters the house through copper pipe to the newly installed ground where the electrical panel is located, but it's done. I always thought that the copper pipe in a house was a great ground by itself. Different inspectors wanted different things done, I suspect that the regulators are very similar and different ones will want different changes made.
Tax court is much the same, if you go to the IRS for advice, and tax court say it's wrong, then it's wrong and the FDA advisors got it wrong.
Gary
Many of the delay's I've seen from the FDA have revolved around commercial manufacturing and shelf life of the product. In the UK, and apparently the rest of Europe they approve the the commercial manufacturing facility before a submission is made for approval. Applying to the FDA before the manufacturing facility is complete may save time as the inspection can come months after the submission, but inspections often require changes and reinspection's which often delay approval. The fact that the European inspectors approve a facility doesn't guarantee that the FDA will accept it without any changes.
Some companies invest in commercial equipment, or contract with CDMO's for commercial quality material for running the Phase 3 trial. If that's the case it certainly lowers the burden in filing for approval. I know nothing about what AVLX has done to prepare for commercial production anyone's welcome to fill me in.
Gary
I believe that the suit is purely in Posner's capable hands, LP is spending her time on approvals of DCVax-L, the EDEN unit, and yes she'll get the Annual Report completed by the time it's due when an extension is legally requested.
I suspect that the handwriting will be on the wall if the Judge accepts what Posner supplies, if not, the case is over, but if accepted I suspect that it won't be long before the case is settled. The last thing the MM's want is airing out their actions in court. I would expect that Posner would need to get LP's concurrence before any settlement was concluded, unless the two already agreed to the minimum they are willing to accept. It's my understanding that Posner's firm took this on contingency, they'll see nothing if the case is lost. I still believe they'll be well rewarded.
Remember, the lawsuit is just the icing on the cake, it really isn't worth spending a great deal of time on. The company is providing a gourmet meal, the cake for dessert will be good with, or without icing.
Gary
What people need to realize is just how big a regulatory filing is. I don't know if AVXL's will be as large as NWBO's, but theirs was 1.7 million pages. My point is, it's a major undertaking and one which you want to make as perfect as possible. It is better if they spend the time to do it right than rush to do it quickly.
Gary
Thanks to all who've responded to me, definitely giving me food for thought. I understand that Ford is speaking the company, I'm seriously looking at the 2025 Mustang Mach E as I understand that in 2025 the extended range battery will be the faster charging unit that also can be fully charged all the time, and it will have the Tesla plug. I don't think it will be the Coretec battery, but still an improvement. I intend to tie it to my solar system in a manner that uses the car battery for emergency power and routinely I'm using it rather than the net as long as the car is above a preset minimum I can establish. Unless I'm planning on a trip, a 30% charge would more than get me around town on a busy day.
As I understand it, solid state batteries can be either lithium or sodium based, they seem to be the long term future, but that too could certainly change. I do want to learn more about CRTG and will certainly post if I do take a position.
Gary
I've only recently discovered this company and wanted to ask a question of two about it. It certainly looks like a major improvement in a lithium based battery, but how does it compare with the solid state sodium battery that I understand the Chinese are already making, and Toyota appears to be committed to. If in some ways it's superior, I'd be serious about an investment here. However if the solid state battery is superior, why would Ford, or anyone else, invest in a better battery than the current one when something substantially better also exists. I'm uncertain, but gather that certain solid state sodium batteries don't require lithium at all.
Thanks,
Gary
In the past they have previously delayed, as long as I remember they didn't reveal what the earning numbers were. Perhaps I'm wrong, but this is the first time I remember seeing them, and they do look like a big improvement on the year prior numbers.
It's probably been the better part of a week since I first noted that being late is really not a problem as long as you file to do so, well now they've done it and we can anticipate the Annual Report anytime in the next two weeks. We know the earnings numbers, possibly subject to change, and they look good to me, I'm fine waiting up to 2 weeks for the rest.
Gary
I believe that the EDEN unit has sensors that need to be in contact with the cassette at all times during the process. That would make serial processing impossible.
Gary
Honestly I have no idea if Daybue had identical acceptance criteria, but would suspect that the bar was set higher for our drug. In most cases, gaining approval means improving on the current therapeutics, if our drug's goals were higher, and just missed, it still may be superior to Daybue. If anyone here knows, I'd like to hear about it.
Gary
The question I'd ask is, if it was judged to be successful in adults in Rett's, but questionable in children, shouldn't the regulators grant approval for at least the adults, and permit off label use in children while additional data is being gathered for full approval. As I understand it, the evaluation in adults is more easily determined, whereas in children, especially on placebo's, is far more questionable and subject to error.
It seems to me that preventing all access to the drug is not in line with - First, do no harm. I don't believe harm is being done by the drug, but some clearly seem to be doing better.
Gary
Are others having trouble with I-H with double posts and in moving from message to message.
Thanks,
Gary
Personally I know no one with Rett's, but many with what my be AD, or some other form of forgetfulness, I really don't ask. I can't say how much benefit our drug could have, but I'm hopeful it would have some benefits. Some of the people I know can remember me from decades ago, but forget we saw one another ten minutes earlier. Others remember everyone around them, but have no idea where they left a phone, sweater, etc. My point is, it affects people differently, and any improvement or even just stability, would give those who care for them a great deal of relief.
If the regulators do approve a number of products, I suspect that some patients will do better on one product, others on another. I suspect the deeper we get into AD the more we'll find that many variations exist, and different products work best with different variations. From what I've seen our drug should be worthy of approval, but it will be far from the only product approved for the disease. Much the same can probably be said for it's use in Rett's, Parkinson's, and other diseases.
I can't say approval with the FDA or anyone else is an absolutely sure thing, but I believe it's certainly worth finding out, and I do like our chances.
Gary
When I first bought NWBO stock the bashers were saying they'll never successfully end the trial.
Then they said, they'll never get a peer reviewed Journal article.
Then they said, they'll never file for approval with a regulator.
Then they said, okay, they filed with the UK, but never the FDA.
It won't be that much longer before we have UK approval, approval to use the EDEN unit for commercial production, and then filings with all the regulators, production partnerships, new trials, etc. Of course before all these good things happen, the bashers will say they can't, but we all know that they're batting .000 and have struck out in every at bat.
Gary
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