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Thanks all for the wishes.
Gary
That is what I thought it was for a couple days, EKG said otherwise. Still waiting to see if Dr's. want immediate hospital visit. I tend to think that they will want me to go to the ER.
Gary
There are people who believe that there is a billion shares naked short position. I believe that the only way it is possible is if the MMs themselves are the ones maintaining it, perhaps through hedge funds that they are associated with.
Personally, I am having a heart issue, I think that it is minor, but expect I will be told to check into a hospital.
Gary
The UK will tell us when they started counting. Just count backward 150 days from when they approve the vaccine, and you'll have it.
Gary
Thanks Hank,
I wish we could get anything done with such speed, we need 2-1/2 months to do what they do in a day or two. The best part is that they don't start running for the next election until a matter of weeks before they hold it. I'll bet my email count would be down 90% if I didn't get political solicitations, 80% of which I don't bother to open.
I really hate the adds that insult our intelligence, things like just send money and we'll get rid of the electoral college. It takes a Constitutional Amendment and I'd really like to know how the tiny states can be persuaded to vote for it, and give up their benefits. No one says, just send money and we'll do it.
We need a Congress that can compromise on legislation, not the stalemates that go on for decades on issues like the treatment of aliens. In reality we need many of them, we should figure out a way to bring in what we need legally.
Gary
Doc, I have to disagree. The key to supplying all the DCVax-L that's demanded is having enough EDEN units to do it. Depending on how NWBO wishes to handle the EDEN units I've got to believe that those doing the production, distribution and sales of the vaccine will be leasing the EDEN units they're doing it with. NWBO should be completely responsible for the maintenance and updating of the equipment, they should be tracking every disposable cassette, and I believe that if CRL as well as Sawston are signed up to lease all the EDEN units needed, they can fill the demand.
BP's handle products by the thousands to millions of doses, it doesn't integrate well if they have a mix of those and vials of a vaccine that are shipped out individually cryogenically for a single patient as requested by the oncologist. The Memphis facility CRL purchased would be the starting point, but CRL has facilities in many places that already have most of what's needed to support having EDEN units added to their existing cleanroom facilities. Furthermore, if they need more facilities they have the financial resources to build them.
Let's get the approvals for the vaccine and the EDEN to make it, with that I believe the only question will be how the units are to be handled, and by who, I believe they'll be Advent and CRL, but it's possible that others may be involved as well. I'd not be surprised if places doing clinical trials would get EDEN units and be licensed to use them for the trials. UCLA currently makes the vaccine manually, with all they're doing I would think it would be wise to provide them what they need for all the work they're doing. The beauty of the EDEN is you can license it and lease it where you choose provided they have all the other equipment needed to support it.
Gary
It would seem to me that NWBO has advanced through a variety of Govts. in the UK, USA, etc and I really don't believe it changes things dramatically. I don't know how quickly a new Prime Minister takes over in the UK, but I doubt if it takes as long as here in the US, but we still might get approval before it happen.
I really don't know why the Prime Minister called for the election early, but clearly if he thought he'd be re-elected he made a serious mistake. I forget exactly how much time they have to campaign in the UK, but I believe it's only a matter of weeks. I wish the same were true in the US. Currently campaigning for the next election begins the day after the current election, and in some cases sooner than that. If we made all campaigning publicly funded I suspect the savings could greatly reduce the national debt, but only if the money being given to the candidates were given to the govts. I can't believe the money we contribute to political campaigns can't be spent better, and I really don't think we'd bankrupt the mass media if they weren't getting all the money from politics, but clearly they'd be hurting.
I don't believe that once DCVax-L is approved there will never be a reason to advertise it. I believe the word will get out to Drs. and patients alike and if you can qualify to get it, it would be medical malpractice not to use it. In the beginning the problem will be inadequate capacity, but with the EDEN unit approved and plenty of disposable cassettes it won't take too long to catch up. If there is competition for patients it will be with those making products that compliment DCVax-L. Trials run after DCVax-L is approved with a variety of products like Poly-ICLC and Keytruda may show one superior to another, but it may vary from patient to patient even if the cancers are essentially the same. As more is learned about the patient, a better determination will be made on what therapeutics works best with which patient, but all will be using DCVax-L because it's made from their cancers and will be effective against them.
Gary
Does anyone think the merger will be completed in the next week or so rather than coming down to the end of the month. I would certainly hope so, but it seems like things don't happen until deadlines are approached.
Happy 4th of July,
Gary
It's saddening that bashers can make roughly a 150% improvement in the chance for survival sound insignificant, and also ignore that if other therapeutics are added the improvement is over ten times what todays SOC achieves. What's sadder is that people listen to them.
The FDA often grants approvals to products that offer a 10 to 20% improvement in OS, without the additional therapeutics we're doing roughly 150%, but of course it's based on a very low number at the start, only about 5% survival at 5 years. If we were looking at a cancer where 50% survived at 5 years and we boosted the number to 60% the regulators would be thrilled. We're doing far better than that, but 13% survival at 5 years just doesn't impress. Add Poly-ICLC and it's very different, but of course that's only in an early stage trial.
We all know that many technologies are advancing to improve the treatment of cancer, but most have years to decades before we'll know how good they are, or more importantly, if combined with DCVax's they'll do better. What we do know is that our vaccine is truly personalized, not something intended for just a percentage of those with a type of cancer they call personalized. Our vaccine has almost no negative effects, only positive ones. Perhaps most importantly, once the EDEN is approved and the regulators agree, it will be available first for GBM, but eventually for practically all solid cancer.
Let the bashers bash, we know better and it's just a matter of time before most of the world knows it.
Happy 4th of July all,
Gary
Happy July 4th to all here in the US.
We also should remember that it's not celebrated in the UK, so we're a day closer to approval, whenever that may be.
While I still believe it could be any day, if others here who believe it's months away, I can live with that as well. The key is approval, a year or so from now the date won't matter at all. Everything doesn't stop or go based on approval, work on the EDEN continues, as does work on new regulatory filings, and work on new trials, but approval may come prior to these things being finalized, filed, and started.
By the end of this year we should be dramatically higher, to me roughly $2 should be the lowest we'll be by the end of the year, nearly 5 times where we are today, but $5 or more certainly isn't out of the question. Let's just give it time to happen.
Gary
Ex, to say BP's are not interested is foolish, Merck even put an executive on the inside to kick the tires. The truth is, they all know how much LP demands, somewhere in the $20+ a share range, and she knows they'll be interested when she grows the price into double digit dollars.
BP's are often like vultures, they circle tiny biotechs until they've practically kill them, then acquire them, or their winning technology for pennies on the dollar. That won't be happening here. LP is a master at getting things done and the initial approval is just a matter of days, I can't say if it's less than a week, or more than a couple months, but it's certainly this year and that will begin a series of events that does take the company to the double digit share prices where we may hear from one, or more, of the BP's.
Don't get me wrong, before that one or more of the BP's may co-sponsor trials with NWBO, but they won't be getting an equity position in the company of any size until we're at double digit share prices. Co-sponsoring trials will almost certainly be a big positive for share price, so it may happen faster than most think, but I believe any new trial will have the DCVax-L produced in the EDEN unit, so the regulators will have to agree to that, even if they haven't yet agreed to its use in commercial production yet. I still believe that such trials are possible before year's end, but it's not certain it can.
Gary
You're right, NWBO should be able to discuss what's there I would think.
Gary
The way I understand why the company doesn't discuss Poly-ICLC is because first of all NWBO didn't sponsor the trial that used it, and secondly because to my knowledge trial results haven't been subjected to peer review. Certainly the company knows all about it, and if they had sponsored the trial they could say something. If UCLA had presented it for peer review I believe they could quote from what had been presented. I believe UCLA has discussed what they're doing, and how well it's going, but not where it was considered a peer reviewed presentation.
I do believe that if NWBO could acquire. or in some way merge with Oncovir it would be a great move, but I don't suspect that's possible before we have at least UK approval, and perhaps not until there are more than that, or at least we've applied to others. The key may be the stock price and I don't believe that LP would give up the number of shares it would take to do it at current prices. Once we're at $5 or more, perhaps it would be more feasible.
Gary
I guess you don't believe that people like AdamF, etc do work with shorts to manipulate certain stocks, while leaving all others alone. There may be some degree of manipulation on much of the market, but certain stocks, and unfortunately we're one of them, are selected and sometimes such stocks are driven out of business.
Success in biotech often takes dozens of years, many companies are either acquired or go belly up before it happens. Sadly the success often isn't seen by the developers of the product, but rather by the BP that acquires them, often for pennies on the dollar. I don't believe that will ever happen here, but LP at some point may sell, but not until she's guaranteed the success of the technology. I'd prefer seeing her keep it independent, but at the right price I doubt anyone here would object to a buyout.
Gary
You may be right, but it's hard to say the 7 MM's can get together on a number to present to Posner. Clearly Citadel is the largest, but I doubt they have much control of the smaller firms. I wouldn't be surprised if Posner settled individually with certain firms who didn't want to risk what they might lose in a joint settlement.
Gary
Xena, I believe you know about NWBO's suit for spoofing against 7 MM's. If this ever reaches court I feel certain it will show that the MM's are helping the shorts and hedge funds to keep the share price down. Some believe the naked short position in NWBO could exceed 1 billion shares. I don't believe this will ever go to court as the MM's won't want the way they do business to be exposed, I'd not be surprised to see it settle shortly after the judge dismisses their last MTD motion, which could come any day.
I would hate to see more companies have to pursue such actions, but if the regulators just keep ignoring naked shorting it may come down to that.
Gary
I'll certainly agree with you there.
By the way, here's a great article on naked shorting thanks to Xena on AVXL.
https://oilprice.com/Energy/Energy-General/Naked-Short-Selling-The-Truth-Is-Much-Worse-Than-You-Have-Been-Told.html
Gary
Unless I'm mistaken, substantial financial penalties could be involved, but unless the Govt. takes on the MM's, this is a civil suit and can't result in jail time. I doubt this will ever go to court where the govt. would see what's presented and could take action. I really believe that the SEC rarely digs into such cases, especially when it comes to OTC stocks, but anything is possible. The SEC has all to often ignored violation of their rules, in 2008 they went so far as to say for a certain period of time naked shorting of bank stocks would be prosecuted. In other words, for some brief period of time they would actually enforce the law. What is the good of having a law that's essentially being ignored and where you announce things are bad enough that you intend to prosecute it, but only for a short period of time.
Some people believe that over a billion shares of naked shorting has occurred here. To put it another way, that would be perhaps a half billion dollars worth of stock being issued that NWBO wasn't paid for if the average short was at $.50. What would NWBO's financial position look like if they had $.5 billion more in cash from sales of stock.
Gary
Newman, we're in complete agreement if the UK approval comes in sometime in the next month or so and is a surprise. On the other hand, I would suspect that the smarter shorts are trying to slowly unwind their positions without driving the share price up. These people are well served by MM's trying to keep the share price low.
Let's hope it isn't much longer before it becomes clear that Posner's case will go to trial unless the MM's settle prior to that happening. I don't believe the MM's will risk going to trial which would expose them to SEC scrutiny, as well as a substantial risk of a verdict against them that could go into billions, or certainly hundreds of millions. The question may be, does Posner make them an offer to settle quickly, at a lower price, but convince them the longer they take, the higher the price will be. I would certainly hope that her lowest price is in the hundreds of millions.
I believe that no matter when the approval comes we'll have a short squeeze, there are certain people who'll simply have a short position that's so big they can't possibly eliminate it, but they may be trying to reduce it. I know some here who believe that if it takes another 2 months or more before we get the approval the lower $.30's aren't off the table. I don't think that possibility can be denied unless the company has other news that should buoy the stock between now and then. If I were short, I'd be working my way out today, but those who believe we could see low $.30's will probably hold their position in the belief that will happen.
Gary
Out of curiosity, does anyone know if people who've had their surgically removed tumors properly preserved also had leukapheresis and that preserved and now are diseased. If so, wouldn't this be ideal for running comparisons between EDEN and Artisan methods used to make the vaccine. I suppose another question would involve making vaccine from properly preserved tumors and leukapheresis from healthy volunteers simply allowing the vaccine to be made for comparison.
Just a thought, trying to figure the best way to compare apples with apples to assure the EDEN meets requirements of the regulators.
Gary
Please correct me if I'm wrong. As I remember it, NWBO announced that it was making certain material changes in the EDEN to make cleaning and maintenance of it better. I suspect that this was the result of an inspection of the EDEN by regulators who recommended the changes. I don't know this to be the case, but if it were wouldn't it be equally possible to believe the regulators were actually observing the operation of the units and perhaps studying the vaccine being manufactured in them.
I'm not saying this is the case, just looking at possibility. I don't believe the material changes would effect the output of the unit, especially if they're not in the disposable cassette, the only part that ever touches the vaccine. I believe they've ordered production models with the material changes required and hopefully will shortly have some operational at Sawston.
It's clear that LP is playing her cards close to the vest, she was more open about many things anticipated in the next 18 months, but short on specific goals or scheduling, something that is typical of biotech CEO's across the board. This was certainly the best presentation I've seen from her in the few years I've been an investor. I believe that she was being cautious about saying they still expect RFI's rather than saying we're currently at a period that's more than double where this is normally received, so it's very possible there will be no RFI's at all. In the back of my mind I believe that she'd be thrilled with an approval that totally shocked the shorts still working hard to manipulate the stock.
Gary
Doc, that really sounds low for treatment of a deadly cancer. I wonder if it was only drug costs, no hospitals, Dr's. visits, surgery, etc.
Gary
I didn't say no cash involvement, I said not until the price is dramatically higher, that could happen with UK approval alone, if the media coverage is good. Regardless, the company could also be funded for participating in trials by BP's. Even if the share price isn't more than a couple dollars, they still have hundreds of millions of shares available to them, so dilutive funding can bring in hundreds of millions.
There is no doubt that they need more money, or will shortly, I don't believe it's necessarily as much as others seem to think if it's there intent to have contractors handle everything regarding the manufacture, storage, distribution and sale of all products they develop and bring to approval. There are many ways of using the EDEN, it can be a profit center, rather than a cost, if that's how they choose to use it.
Gary
I don't believe that this is the case, no doubt the BP's are interested, but the timing of what's happening is largely governed by the time required to manufacture with the EDEN unit. It's doubtful that BP's could have developed this unit any faster than FlaskWorks. I don't believe that the idea of building thousands or more tiny cleanrooms has been a consideration for years, so EDEN acceptance has always been the critical path to multi-national approval. Gaining approval in the UK with artisan methods is highly beneficial to prove the effectiveness of the vaccine before the other regulators are approached, but the EDEN is the key to filing with the others.
I do believe that Merck, and perhaps others, have agreements to work with NWBO on trials, etc. in the future, and taking an equity position may be a part of it, but not until the share price is dramatically higher. When the time is right, I believe that many things will be happening, LP said as much, but nothing will be revealed until the time is right.
Gary
There is no if, in the UK the artisan method was approved for commercial production a long time ago. The key to the future is getting the EDEN approved, but late this year, or even early next, may be the best we can do.
I don't believe they'll attempt FDA approval without the EDEN, but Europe and/or Canada might be considered while still only having artisan method production at Sawston. I frankly think Sawston will be swamped, but I've been told that it doesn't matter as far as requesting approval. I suppose if the demand is great enough there may be contractors willing to devote available cleanroom space to production of DCVax-L. I was also told that it may be possible to use units that are portable, similar to incubators for premature babies, where all manipulation of what's inside is done through gloves. I gather that each unit has it's own air supply to avoid contamination. I can remember seeing such units in cleanrooms as I was moved underground between buildings at City of Hope where I gather many labs exist there.
Gary
I don't see it as an excuse at all, new trials should be run by making product in the EDEN, until that's possible, they shouldn't be started. I don't believe it will be that long before they have the units and I believe they'll meet the criteria for trial product even if they've not yet met the criteria for commercial production. In starting the trials with the EDEN all doubt will be removed as to it's use when the trial is concluded and they apply for approval.
I don't know if up front they can designate the DCVax-Direct trial as a Phase 3, but if started as Phase 2 it potentially could be a registrational Phase 2 or transition into a Phase 3 with all data from the Phase 2 portion included in what's considered as Phase 3. I don't know if they've continued to track the patients who were in the Phase 1, but many were alive when they last reported on the trial. As I remember it, the longest living was a pancreatic cancer patient, probably the most deadly of all the cancers in that trial.
Gary
Doc, was the $135K you mentioned the annual cost, or the overall cost of treatment. I suspect it would be higher today, but still most patients don't survive 3 years. I would suspect that the overall average cost of treatment ranges somewhere between half a million and a million dollars.
Clearly the overall treatment cost could go up with our vaccine, but annualized, with many people living far longer, it should come down as many reach the point where their only cost is routine check-ups with their Drs. that they remain in remission.
Gary
Doc, while I agree the UK knows the EDEN will be needed to meet demand, I still think they'll approve as soon as their decision is complete. At that point the heat will be on them to approved the EDEN, but I think that they can live with that.
I'm frankly uncertain just how much capability exists to make the vaccine manually outside of Sawston. Clearly they have some capacity in London, I really don't know what they can do at FlaskWorks itself, and that brings us to CRL, if they're contractually available. It's a massive company and no doubt has many cleanrooms, but I have no idea how many could be dedicated to manual production of the vaccine if it were available. We know UCLA can make one batch monthly, and I believe Germany may have that capability as well, but my point is, it's very limited capacity. Hundred or thousands of EDEN's could be deployed in a matter of months if they were available. I believe that NWBO will have suppliers who'll be able to deliver hundreds of EDEN units monthly once it's approved.
Gary
If a BP has met with LP I believe they got a clear message that taking an equity position in the company wouldn't be welcomed at below some specific stock price they were paying to take that position. I believe that price is into double digits, but regardless of what it is, the BP won't make a move until the share price reaches at least half of the price LP has specified. It's premature to discuss a BP equity partnership, but there are other things a BP can do with NWBO.
One of these things would certainly be sponsoring, or co-sponsoring, a trial that uses DCVax-L along with one of their products. Money may be paid to NWBO for doing this, but no stock would be acquired by the BP in such an arrangement, or their could be an option to purchase in the future at agreed upon prices that aren't specified at the time.
To me the key to all of this is the EDEN unit. I don't believe that sufficient production resources exist to run trials and deliver approved vaccine to paying customers without using the EDEN, and I also believe it foolish to initiate new trials without using it. I'm of the belief that the EDEN could be used in trials before it's formally accepted for commercial production as trial product doesn't have to meet the full standard of commercial product. On more than one occasion I've seen the FDA delay approval because they were dissatisfied with the commercial production facility, but otherwise they were intending to approve the product. Clearly the trial material was sufficient to produce acceptance, but the means of commercial production had to be improved on. In some cases this resulted in substantial delays.
Gary
Doc, time will tell, but I believe we're closer to production with the EDEN than people realize, in part this may be because once approved the UK will want the company to be able to meet the demands. I believe some EDEN units are ordered for use at Sawston, once installed I really believe the UK authorities will be eager to confirm that they're working properly. I'm not saying weeks, but a few months, prior to year's end is very possible if Sawston is working with the production units in the next month or two.
Remember, the UK approved the manual production facility long ago, they knew its capacity and didn't balk at it being insufficient for meeting the demand. I think it's clear that they know what's coming and we just need to give it time and it will happen.
Gary
I've been saying this all along but people here refuse to believe that we can go through the entire UK procedures without even one RFI in spite the fact that we're now past day 150 and haven't received one. I'd have to guess that LG, and probably others at the company believed we'd be asked for additional information, but to date it hasn't happened. Clearly there are no guarantees, but I still believe an approval could come any day.
As for todays reaction to the Annual Meeting, clearly those manipulating the stock took control from the open, smart shorts are very probably working to close their short positions before any further news reinforces some of the positives that came out of the Annual Meeting. In the last hour we might rally and actually close in the green, but if not, it shouldn't be long before the report of the Annual Meeting is out and I still believe the meeting was an overall positive, even if the MM's actions brought us down at the open.
I would suspect that Posner will be looking into the trading this morning if she's free to add to the evidence she's gathered against the MM's.
Gary
I certainly know nothing about this, but aren't these cleanrooms run by Advent and intended for production. I would think that NWBO development would be done in NWBO facilities, either in London or the US. Of course it's also very possible that the individual cleanrooms could be turned over to NWBO by Advent as needed. I really don't know what NWBO has where, but I doubt if NWBO would be developing anywhere close to the number of new products those tiny cleanrooms represent.
Clearly those rooms cost a lot to build, I think someone estimated that each could hold something like 10 EDEN units, so they could be of benefit, but the question might be, how many of them could be needed in the future. I'm unsure if NWBO still owns more property in Sawston, if so, adding new buildings with large cleanrooms, etc. is probably preferable to reconfiguring what they have for greater production.
Gary
Once you construct the tiny cleanrooms to manufacture DCVax-L manually, I would doubt the cost of doing so is terribly different from doing it in the EDEN unit. Certainly it would cost far more to build tens of thousands of these tiny cleanrooms, but for those that already have been built, the actual cost of a batch made in the tiny cleanroom manually and the batch made in the EDEN unit probably isn't more than $10K different, and probably less than that.
I'm saying this because I believe that NWBO will be establishing a price with NICE, or anyone else, based on providing the vaccine regardless of how it is made. I would suspect that more will be charged for making the vaccine, then either a fixed price for each dose, or perhaps some scale where each succeeding dose is slightly lower until the entire supply is exhausted.
To me it's unclear if NWBO will receive a part of the payment for each dose, or receive their money up front from making the initial batch and nothing thereafter. It's all a matter of contractually what they agree to with Advent, or anyone else contracted to make, cryogenically store, and supply the vaccine as needed.
My point is that all this can be established regardless of the method for making DCVax-L as all the planning has no more tiny cleanrooms being built, and eventually everything will be converted to EDEN production. Frankly I have no idea if they'll simply pack several EDEN units into each tiny cleanroom, or if they intend to tear out walls and rework the spaces into one, or a couple large cleanrooms. Hopefully they were designed to be easily modified.
Gary
Doc, I think that LP's view of the next 18 months was more optimistic than yours, but you could be right. I really believe that by the end of this year at least the UK will accept use of the EDEN, if I'm right, once they do I believe the US and others will fall in line. I've been saying all along that I believe the EDEN was the key to filing with the US and probably elsewhere.
As for the act of filing, I would hope that less than 1% of the pages in the 1.7 million pages they filed with the UK require changes, but even 1% represents 17,000 pages. In the UK the commercial production facility was previously approved, for the others I would think that it would have to be added, I don't know how many pages that would require, and of course the inspection of the production facility would be part of the overall acceptance process.
The question may be, if you anticipate EDEN acceptance in December, would you file with the FDA 3 or 4 months prior with the thought that you could have the production facility ready for inspection a few months prior to the PDUFA date. If you did that, and the EDEN weren't available, the worst case would be a CRL from the FDA delaying until the EDEN was ready.
I may be optimistic thinking the EDEN accepted by December 2024, you may be pessimistic thinking December 2025, but frankly as long as it happens sometime, we'll be just fine. There is no doubt, initiating new trials and filing with the regulators cost money and take time. I have a feeling that LP has a few tricks up her sleeve that she's not yet ready to reveal to get the job done.
Gary
In the next few days the company should put out the official report of the Annual Meeting, I'm uncertain if it will purely have the vote tallies, or if it also will summarize all the comments made at the meeting, which I hope it does. I don't know how many Annual Meetings I've been involved with from multiple companies through the years, but this was by far the most enthusiastic. While the meeting didn't provide specifics, IE X will be completed by XX date, it provided a lot of guidance on where they're going and the confidence that they'll get there.
While I believe we should be up tomorrow, based on the Annual Meeting, I can't say that those manipulating the shares won't work their hardest to prevent that from happening. Will we see the likes of AdamF bashing the company tomorrow, anyone's guess. On the other hand, could the company have something more, something beyond the report of the Annual Meeting to announce, anyone's guess there as well. One thing is clear, the company has many things in the works, they may have pretty much finalized them, but they'll not announce them until the time is right in their opinion.
Gary
It's been nearly half a century ago that I was in a weeks class with Dr. Deming, he's been gone for quite awhile. It's nice to still see him quoted. Much of what he was advocating in the class would have been illegal where I was working, but he was a truly dynamic individual and largely responsible for the Japanese emphasis on quality after WW2.
Gary
You're making the assumption that they'll be asked for more information. The RFI should have happened months ago based on the UK guidelines, I'd suggest that there is a good chance that no further information is being requested, not beyond day 150, which is where we are. LP and others can guess at what the regulators may ask and try to be ready, but all the evidence, beyond day 150 with no information requested, that no further information will be needed.
I still suspect that LP believes this could be the case, but what better way to get the shorts than getting the approval months before they anticipate it happening. Naturally I have no proof that this is the case, but I think it must be considered.
If in reality the regulators are taking over 150 days to get what supposed to be done in 80 days, then it may make sense, but I really don't believe the UK record is taking roughly twice as long as their goals to get things done.
Gary
How do you figure that Mike, you're adding nearly 140 days to their 150 day goal. I'm not saying it can't happen, but why do you think it will.
I was really of the belief that the UK was working to beat the FDA with it's PDUFA dates 6 months after the acceptance of the filing. Granted, the FDA doesn't always meet their date, but they announce delaying the target. I'm starting to like the FDA more than I did in the past.
Gary
I heard what she said, but I also heard he say they wouldn't notify shareholders of precisely what was happening. We're actually past day 150, into that 60 day questionable period, I really can't believe at this point that nothing's happened regarding these things in the first 150 days.
If I were in LP's position and believed that there were many shorts still working against the company, the last thing I'd do is tell them just how close I believed approval could be. On one hand she made it sound like nothings happened, on the other she said we wouldn't be told when it did, I'm only suggesting that her words can be taken more than one way.
If in fact at beyond day 150 no RFI has come from the regulators, I think there is a good chance that the regulators are satisfied with what they've seen. I believe the regulators have been very involved with the trial, if that's the case, they may not feel they need teams of inspectors speaking with people that they've spoken with before, and the evidence is in that 1.7 million pages they've been provided with. I don't know this to be the case, just believe it's possible. That makes Monday possible, but likewise, if they still are doing the inspections and have questions to ask, their goal should still be 60 days, which puts it at the end of August. Certainly they could miss their goal, but I'm guessing they'll make it.
Gary
Does anyone believe a new trial, at any level, will be started without using the EDEN unit to make whatever the product is in the trial?
I'm of the belief that the company can set up the trials in that way, it will be up to the regulators to accept it, but it should be able to be done before the EDEN is approved for commercial use as trials don't have to be done with commercial quality product.
Gary