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If you don't know what an inspection is for, and if you over the years have spent time working with the regulators, perhaps you've already been inspected without even knowing it. I suspect the British Regulators already know all they need to about NWBO.
Gary
Marty,
I previously brought up the point that many at some point take back their money, that's fine with me if at the time you do it you either need it, or have a better place to invest it in. My point was only that if you believe the potential is as good, or better than in the past, why sell. Of course if you need the money, that's a different matter.
I know people who automatically sell half after doubling, they often forgo tremendous growth just to get their initial investment back, though they don't need the money. I just think before selling, if I don't know of a better investment or need the money, I'd ask myself why. In the case of NWBO, if it's still advancing on a tumor agnostic label, I doubt if a stock with more potential can be found.
Gary
Going from 5% to 13% survival at 5 years is certainly no failure, it's over 150% improvement in 5 year survival, that by itself would be worthy of approval, and actually far better than what's achieved with many approved products. A 10% to 20% improvement in OS has moved many a product to approval, we're better than 150%, but it's in a cancer that's among the deadliest. I frankly don't believe the regulators will ignore the benefits achieved with Poly-ICLC taking the survival to over 50%, but they'll permit it by adding them to a compendium list permitting use covered by insurance essentially from the time DCVax-L is approved.
Clearly you're also right, many others are benefitted by living longer than previously, but not over 5 years. I would love to see a K-M that showed every patient to enter the trial extended out to the present. I don't know, but believe we might find that some of the patients who were first to enter the trial are still alive today.
Gary
Marty, I suggest you consider what's happening at the time before selling at $4. If you really don't think it's going much higher at the time, fine, sell, but if you like the potential of rising to double digits, and beyond, why sell.
My biggest complaint with many Analysts is when a stock reaches their target they lower their rating on it. Rating it a Hold is really a sell signal to those who buy on their new buy recommendations. When the stock doubles again the Analyst takes full credit for the entire gain, they told you to hold, if you held you'd have the entire gain. In my view when the target is hit it's time to reexamine the stock, if you can't raise your target at that point, say so, but perhaps the rating in that case should be sell rather than hold. On the other hand, if you raise your target by 10% or more, perhaps hold is justified, while putting a buy on a stock that should do better than that.
Analysts for the most part work from brokerage houses, therefore they push the stocks they're told to. The only broker I'd care to follow is one who's independent of brokers, but also has subject matter expertise. A poli-sci major does not constitute having medical expertise. I'm really not following anyone in particular right now, but used to like Jim McCammant's when he was around and writing his newsletter.
Gary
Marty, I think that figure is an average between products getting priority reviews and the ones getting normal reviews. The 150-day mark is established for priority reviews, and they want to shorten it to 120 days.
Gary
Marty, there has been a great deal of language saying the 150 day is from submission, I can't remember previously seeing validation as a starting date. I certainly can live with it if it is validation, it's roughly one month longer, but I still like the idea that we should know in just over a week, or less. Remember, 150 days is the last day they target to make the decision by, they frequently do it in less time than that.
If they made the decision by May 20th, we really couldn't say that they made it at about day 150, or was it actually day 120 based on a later start time. Perhaps they even met their newer 120 day guidance, but clearly from validation. All I'm suggesting is, the regulators just keep everyone guessing, and companies are no better when giving guidance, it's just not concrete, there is always wiggle room.
In the case of the FDA they set the PDUFA at 6 months after they accept a BLA or NDA, but I don't believe they say how long they spend in accepting, or whether they have precise guidelines on how much time they take. Al least once a PDUFA date is established, all know what their target is.
Gary
Marty, if there is an RFI at this point or beyond, the UK would not be following their own guidelines. It is possible, but I believe it is doubtful.
Gary
I still like the odds that we will have an answer from the UK by May 21st, and it will be yes. The question in my mind is whether they will want a confirmation trial.
Gary
Please correct me if I am wrong, but I believe that Sawston was inspected and approved for commercial production some time ago. I don't think further inspections are required unless modifications require additional inspections.
Of course, if they were proposing that the EDEN Unit be used, that would be a new ball game.
Gary
If the March 7th date is to be taken as the 80 mark, the calendar would have been starting with the submission in December.
Gary
I think the quarterly may have revealed something more. In discussion of the EDEN unit it was indicated that material changes were being made to make sanitizing the unit easier. While there is no proof as to why the move was made, I think there is a good chance if was recommended by one or more of the regulators evaluating it. I have no proof of this, but perhaps we're further along than most people think.
Gary
I love it,
My first boat, a 40 ft Challenger sloop, was named Impossible Dream. We lived on it for 3 years, until I shattered my leg in a ski accident. Once we moved ashore we never returned full time to the boat, mostly cruising to Catalina and around Southern California.
Gary
I think it's clear that no RFI was requested, if the UK doesn't act in the next two weeks they've simply failed to meet their own 150 day deadline. To me it's no big deal if that's the case, the FDA has frequently moved PDUFA dates, this would be no different whether the UK people announce it, or not. It's a self impose deadline, I still expect them to make it, but it's not the end of the world if they fail to.
I frankly agreed with others that we'd not see anything unexpected in the quarterly, so I'll admit a little surprise in acknowledging not being asked for further information, but I'm thrilled that they said it. The next week or so are nervous time, it could happen any day.
We'll see how the market takes the news on Monday. I'd expect the bashers will be throwing out everything they can think of to try to hold down the gains I'd expect while waiting for the UK decision.
Gary
Traditionally you'd be right, however, I believe this trial has been done in a manner that's broken traditions, and i believe dynamic action on approval is possible. It doesn't require full approval for DCVax-L with Poly-ICLC, rather approval of DCVax-L and a compendium listing for Poly-ICLC, which has been approved for other applications, to be used in combination with DCVax-L. Keytruda might also be included in the compendium listing.
If this trial had been run in a totally traditional manner, it would probably have ended many years ago and a new trial, structured differently. would have been initiated, and probably not completed for several more years. Fortunately the regulators have become more open to getting worthwhile products through the system more expeditiously. I believe that's why we're where we are, and why we'll get the approval and the compendium listing for Poly-ICLC and perhaps a few others.
Small trials, like those run at UCLA, may be all that's needed to have products like Poly-ICLC, Keytruda, etc added to the compendium listing and give the Drs. choices as to what's best for their patients. The key of course is the approval of DCVax-L as all these other drugs are nearly useless in these cancers if not used in conjunction with DCVax-L.
I realize that many disagree with me, they believe the FDA and others will bounce NWBO's filings because of the unorthodox changes made during the trial, even though they met with NWBO in making them. I believe the UK action will indicate the direction the others take, and I believe that the worse the UK will do is an approval with a confirming trial required in the future. The failure to gain approval that required further trials would delay acceptance of this technology for at least 5 years, and probably much longer, I just don't see the regulators doing that.
Gary
You're right, and we did close down $.005 in spite of what's supposed to be a real time quote on CNBC that said otherwise at the close, and even a few minutes later. It seems as though the MM's are only to happy to fill tiny orders on the down side right at the close. Perhaps we should organize to purchase tiny amounts of shares on the upside at the close. I suspect even with such a tactic the MM's can decide what's their last transaction of the day, so even a plan to buy at the close won't succeed.
Frankly I now have an even 400K share position, it makes what I make, or lose on a given day something that I can almost instantaneously know. I'd rather not add odd lots of shares. I would like to suggest something to investors wanting to add substantial shares, if they have accounts in brokers like Fidelity, who doesn't charge commissions. Let's say you want 10K shares. Order 9,900 during the day and a 100 share order placed as a buy at the close at a price that's a tenth or so above the ask. The added cost should be insignificant, and you may help to prevent the MM's playing games.
Just a thought, I really don't know if we can fight fire with fire, but it may be worth a try.
Gary
You're right, and we did close down $.005 in spite of what's supposed to be a real time quote on CNBC that said otherwise at the close, and even a few minutes later. It seems as though the MM's are only to happy to fill tiny orders on the down side right at the close. Perhaps we should organize to purchase tiny amounts of shares on the upside at the close. I suspect even with such a tactic the MM's can decide what's their last transaction of the day, so even a plan to buy at the close won't succeed.
Frankly I now have an even 400K share position, it makes what I make, or lose on a given day something that I can almost instantaneously know. I'd rather not add odd lots of shares. I would like to suggest something to investors wanting to add substantial shares, if they have accounts in brokers like Fidelity, who doesn't charge commissions. Let's say you want 10K shares. Order 9,900 during the day and a 100 share order placed as a buy at the close at a price that's a tenth or so above the ask. The added cost should be insignificant, and you may help to prevent the MM's playing games.
Just a thought, I really don't know if we can fight fire with fire, but it may be worth a try.
Gary
It closed up, just $.004, but better than down. It's worth well over $1K to me, and I suspect that's true for many here.
Gary
I know little about NICE, but I have a feeling that they pay for treatment for patients with cancers as deadly as pancreatic, in spite the fact that nearly all who can't get the Whipple procedure will be dead in a couple years, or less. If this is correct, if anything, our vaccine has a much greater chance at long term benefits over pancreatic cancer treatment.
Add Poly-ICLC and the benefits are tremendous, but of course it's only demonstrated in small Phase 2 trials.
If anyone serving in making the decisions ask themselves, what would I want if I were diagnosed with GBM, DCVax-L and Poly-ICLC ought to be a slam dunk.
Gary
We're probably about an hour before seeing the quarterly. Does anyone expect any surprise from what we'll be seeing. I for one don't.
Gary
We definitely have different beliefs, I think NICE will consider the use of Poly-ICLC with DCVax-L and therefore see a far greater percentage of patients seeing a major improvement. Furthermore by the end of this year, or early next at the latest, I believe the EDEN will be accepted by the regulators for production.
When you look only at 5 year data you're not seeing substantial benefits to those who don't live 5 years. I've known a few pancreatic cancer patients who very much enjoyed most of the 2 to 3 years they were given with treatment, it probably would have been well under a year without it. While I've not known GBM patients, I believe much the same applies to GBM.
Of course when you add Poly-ICLC 50% are living to, or beyond 5 years. I suspect that many who don't live 5 years will be living to near that point, but more data is really needed. Frankly I think that the crew at UCLA in a larger trial may actually be able to take 5 year survival to closer to 60% or even 70%. Frankly the more they learn about treatment with the vaccine and other therapeutics the greater percentage that will live and the longer they'll live.
Gary
It's my belief that Market Cap is related to the perception of when approval, and therefore revenue, can be anticipated. The market cap should move up dramatically as more becomes known, from the issuance of the Journal, and then a filing is made with at least one, or perhaps more, of the regulators. In anticipating approval short term, the market cap ought to be in at least the billion dollar range, then post approval rising revenue will take it substantially higher.
It's my belief that if the perception is that our drugs will eventually be approved for many diseases, the P/E for the company should be in the 30 area, IE on the high side of the revenue multiples. I certainly believe that with approvals our revenue will go into multiple billions annually, with a P/E of 30 a market cap at or near triple digit billions is certainly in the realm of possibilities. It won't happen instantly, but if the company isn't bought out, it should happen in time.
Gary
My problem with many analysts comes when their targets are hit. Often they will lower their rating to hold and announce new buy ratings rather than setting new targets for the stock. If the stock doubled, they take full credit, after all, they said hold. Where do they think the money comes from when they say buy this, but hold that?
To me, a good analyst reexamine a stock when a target is met. At that point, either a new higher target should be set, or if no further growth is seen for awhile the rating should move to sell.
Most analysts are pushing the stocks their brokerage tells them to, little of their own thoughts apply unless they are independent of a brokerage.
Gary
LC, while your 5% seems small, what you fail to say is it's roughly a 50% increase in the numbers that make it to 5 years, and the likelihood is that those who make it 5 years will live far longer than that.
The FDA has often approved drugs that permit 10% of the patients to live longer, we're talking 50% living longer and many others who lived less than 5 years still living longer than with SOC treatment.
Of course you completely ignore that adding Poly-ICLC or other therapeutics should move that 5% to over 50%, but only if used with DCVax-L. I grant the evidence is only from a small trial, but it's none the less very definitive.
Of course the regulators could ignore all this, they could simply say, go, get out of here, spend another few hundred millions or more and take another decade to bring me proof that's better organized, done the way I demand it to be. They can say, we don't care about the hundreds of thousands of more who won't get the treatment while you're doing the trial our way. I simply don't believe that will happen, I believe that all four regulators have agreed to the changes that have been made in the trial protocol, I believe they all know the benefit that the addition of Poly-ICLC will bring, and while they may ask for a confirming trial that proves it, I believe they'll all approve and do so in a timely way.
Approval will mean nothing if the vaccine can't be produced in the needed commercial quantities, so I also believe it won't be that long before the EDEN Unit is approved so that sort of production is possible without years of constructing and certifying tiny clean rooms for manual production of the vaccine.
The company knows the BLA that's filed with the FDA must provide for commercial production in the US, the facility has to be approved prior to approval of the BLA. I don't believe they file until they're certain that before the end of the 6 month PDUFA period a facility equipped with numerous EDEN units will be acceptable. I'm not certain, but believe the other two regulators can accept DCVax-L that's manufactured in Sawston regardless of whether it's manually made or made with the EDEN once approved.
Years ago I frankly thought investors hurt the DNDN approval process by taking activist actions in an attempt to force FDA actions. Frankly if the regulators turned down DCVax-L something similar, but more professional, would be something I think many of us could support. I don't believe anything like this will be needed, but I can better understand what DNDN investors went through back then.
Gary
I've got to admit that during part of my treatment for leukemia, before stem cells, I was on a drug where two doses were expected to be taken 12 hours apart. Most of the time I was close, but occasionally it may have been as many as 16 hours, and then the next dose 8 hours later to get back on track. I would suspect that if it's really critical to have accurate dosing, and the patients have mental issues, some sort of unit, similar to an insulin pump will be developed and a patient's unit need only be refilled after a number of days, or even weeks.
If not that, perhaps a time release version that could be taken perhaps 12 hours apart. It may not be perfect, but it works better than every 6 hours.
Gary
Someone mentioned a compendium listing where products can be used off label with other products and will be approved by insurance. Could Oncovir be looking to get a compendium listing when DCVax-L is approved and not be required to do further trials, or have further expenses, at all. Both companies after establishing revenue streams may want further trials in other cancers, or raise money in other ways to do it sooner, but the point is on approval of DCVax-L the door may be open to using Poly-ICLC, and getting insurance coverage for it immediately.
Finally there is the thought that once we have an approval and a substantially higher share price Oncovir might seriously consider being acquired by NWBO for stock, or perhaps cash, or a mix of both. LP clearly seems to be looking at the possibility of bringing many things together, some she already owns, but they all could work together and achieve a whole that was dramatically bigger than the sum of its parts. I certainly don't know that this is the plan, or that LP intends to sell out to the first offeror, but it looks more to me that she's looking to build something than to tear it apart.
Gary
I gather that AdamF has taken a shot here too. I hate to think of all the companies he's worked to bring down. Why he's respected by anyone I can't figure, but clearly he is.
Gary
It fits right into the UK 150 day target for approvals. I grant you a RFI can delay their decision, but with 1.7 million pages submitted after a great deal of time spent with the regulators I believe that there is a good chance that no further information was requested. My estimations have always been based on either the 150 day UK target, or the improved 120 day target they've announced.
In reality the UK is looking to do their approvals 1 to 2 months faster than our FDA which sets its PDUFA date 6 months after they accept the NDA or BLA. The FDA does often approve prior to the PDUFA date, but most failures aren't announced until that day.
I believe the UK also often is known to approve before the 150th day.
Gary
Tomorrow I believe we'll either get the quarterly, or the request to delay it up to one week. If we get the report, it's hard to say if it will contain anything, other than the financial facts, that we don't already know.
I would think that they could discuss the Nature article as it's now been published. The only way they'd say anything about the UK filing would be if the regulators there told them something they're required to divulge, I don't expect anything other than reiterating they've filed. If there has been no RFI it's doubtful they'd tell us so, but I don't know it's impossible for them to do it.
I like the odds of being approved by the end of next week, but don't believe it's a reason to hold up the quarterly. An approval should stand alone and frankly I'd rather see it announced early in the week even if they know on Thursday or Friday. I think they're on time whether they issue before the bell in the morning, or after the bell at the close.
Gary
It was quite positive, but about the small trials done at UCLA that used Poly-ICLC with DCVax-L, many patients living for ten or nearly ten years and still alive. The article wasn't being promoted by NWBO, or anyone else for that matter, as NWBO didn't sponsor the trial. IMHO NWBO's being heavily manipulate and will continue to be until the UK approval, then the news should overcome those working to control the share price. Their trial against the MM's for spoofing should be moving forward after multiple MTD's followed by more proof of the MM's actions.
Avanex should have no problem in PR'ing a Journal as they sponsored the trials being discussed in the Journal. Don't get me wrong, I'm sure if you attend ASCO they'll have copies of the article at their booth, but I know of no other formal presentation of the data discussed in the Journal there.
Gary
ATL, we're in complete agreement. I don't believe the company would consider asking shareholders to agree with a partnership or buyout that was based on stock prices that failed to be fair value. On the other hand, until we have an approval, I don't believe we warrant a share price that puts are market cap at multiple billions. Other companies I've followed in similar positions to us, IE near term approvals anticipated, have market caps in the low billion level.
I believe that our share price today should be double to triple the current price, then double of better that on approval.
Gary
Are you saying Les did another appearance, I'd like a link if he did. I don't place a high regard on that show, but I understand it has a lot of listeners, so I'd rather see that than nothing.
I too believe the silence has a reason and when they come out, it will not be just one announcement for approval, they'll be rolling out news regularly. When I say MM's controlling things I'm really including those behind their actions, namely hedge funds with short positions.
I do believe the Nature article was great news, but only because it documents what investors knew was happening, but now we have it in black and white in a peer reviewed article. While I believe we should be priced dramatically higher, especially knowing we're about to get an answer from the UK that most current investors believe will be positive. Clearly many still don't believe we'll gain approval, but if we're right all their arguments will fall by the wayside.
I believe they went with the UK because the UK not only has the most experience with DCVax-L in brain cancer, they also have the most experience in other cancers through their compassion use program. I think they're likely to permit its use in many forms of cancer, and pay for it in their system for their citizens.
I wish I was certain the FDA will be among the next to be applied to, but I still believe that's dependent on the EDEN for commercial production. Barring some exception to their rules, I understand that biologically based products must be made in the US. If that's correct, even if Sawston has the capacity, they can't deliver to the US. I don't believe the same applies to Europe and Canada.
I do know a number of credible posters who don't believe DCVax-L can gain approval, but not because it's not effective, rather because they don't believe the regulators demands were really satisfied in all the changes made in the trial. If this were 20 years ago, I'd agree with them. I believe the regulators have become more flexible, not on what they demand, but on permitting change underway to meet their demands, which also can change while a trial is underway. I believe many future trials will be designed without control groups, the trial outcome will be compared with historical data. We've seen a Journal from the FDA stating this, but not finalized guidance from them on this issue that I'm aware of.
I frankly don't know how the next trial, or trials, for DCVax-L will be structured. If you're going for a tumor agnostic label, can you tackle multiple solid cancers in one large trial, or do you need multiple smaller trials, each for a different form of cancer. In the early DCVax-Direct trial they went after a variety of cancers, I just don't know if they could have expanded that to a pivotal trial, or if the regulators would have wanted trials by cancer type.
I'd agree with you that most investing in biotech's know about the disclaimers in commercials on drugs, I don't think that the viewing public is nearly as well informed. I'd like to know if those of you in Europe, etc. find the same sort of disclaimers in countries outside the US. I believe the regulators go way too far in trying to protect us, rather than trying to benefit us. How many people might have benefitted if the regulators issued EUA's for DCVax-L in the mid 2010's when they agreed to the trial changes during the halt.
Gary
I agree, I've seen it, but in our case I don't believe many longs will be selling. I do believe that computerized trading will trade the very same shares many times in minutes. I don't like such trading, but it's happening and can't be denied. I'd be surprised if 10% of our longs will trade in any given day, but that would be over 100 million shares. With computerized trading those shares could easily be traded over ten times in a day resulting in volume exceeding all shares outstanding.
I frankly can't say how many investors we have that have a number, it might be $2, or $5, $10, or $20 at which they're out and intend to never look back. I know many people who'd consul that if your share double in price, sell half and have all the other shares for free. I can live with that logic if I have somewhere I deem to be better to invest the money, after considering the tax consequences, but if I don't, why would I sell. Even after a ten banger, selling one-tenth is fine, but only if I have a better place for the money.
As long as I truly believe that the DCVax's have the potential to benefit patients with many solid cancers, I don't know of a better place I could possibly put my money. I don't have decades to live, but my kids do, I'm fine with them inheriting what I've built for them, while doing what I want in my remaining years.
Gary
Let's get real about shares outstanding. Is there anyone long here who doesn't believe that NWBO should eventually achieve a market cap that's well into double or even triple digit billions. If that's the case, why fear growing to the 1.7 billion shares authorized, or beyond.
Sure, most companies with billions of shares outstanding rise to multi-billion dollar market caps before reaching billion share counts, but nothing prevents us from doing it the opposite way. It certainly will take time for NWBO to reach triple digit billion dollar market caps, but our share price would still be nicely into double digits well before that. I'd have no heartburn with a $20 share price, and 2 billion shares outstanding over a $200 share price and 200 million shares outstanding. They are exactly the same market cap.
If reverse splits didn't have such negative connotations I wouldn't care about that, but the fact is they do. Certainly some companies have successfully done R/S's, but in almost every case they lose substantial market cap before rising to higher market caps in time. Often the R/S becomes the first step toward bankruptcy. I'd simply prefer they never do it again.
Apple currently has over 15 billion shares outstanding, I don't believe we'll ever be as big as Apple, but if our shares outstanding did reach even double digit billions would there be an objection as long as share price was at least mid double digit dollars. I'm not suggesting that may shares will ever be needed, but if they were to make acquisitions that investors agreed with, would it be a bad thing.
Gary
I'm of the belief that most of the longs are largely satisfied with the positions they've built. The Nature article, while clearly positive, was really only being seen by people already interested in NWBO, most of whom are already investors. Volume wasn't high and the MM's were able to take control after the initial runup today. This won't remain the case when we get word of an approval for DCVax-L.
I doubt if 1% of the investing public have ever heard of NWBO. I suspect that with news of DCVax-L approval in the UK no less than 25%, and perhaps 50% or more will have at least heard of NWBO. Hearing about it doesn't make them buyers, but if even a small percentage of those who hear about it choose to invest, the total number of investors go up by a substantial multiple.
If we get the sort of headlines that creates buying on emotion, we'll get investors who want in, and they don't care about the price, they want their 100, 1000, or 10,000 shares and if it's costing them $5, $10 or more a share. It won't matter to them that over a billion shares are outstanding and the price they're paying is saying the company warrants a market cap that's approaching or is over $10 billion.
Personally I believe that in time NWBO should be worth many tens of billions, even hundreds of billions and more, but perhaps just UK approval along is premature for a $10 billion plus market cap being sustained. In time the investor who pays $10 or more will do just fine by holding, but I suspect many of us will be selling some shares, and looking to buy back substantially more shares when the stock retrenches.
As for volume, once we get UK approval, I would expect 10 million and greater days will become common, at least for awhile. I don't know that we won't get over 100 million for a few days. Life should really be interesting at that time.
Gary
Jesster,
I'm no expert on what they can or can't do, I'm saying what I'm saying because of observing what other companies do, and whether laws apply, or just fear of the regulators, most companies don't like to do anything that the regulators might consider hype.
I frankly hate what the regulators have done. Annual Reports used to be something like a magazine featuring all the company was doing and planning to do, it was enjoyable to look through. Now much of what's in the report involves the risk of investing and all that can go wrong. I believe most investors skip these sections for the most part, but they must be included.
Yesterday I was talking with a retired Dr. friend about all the cautions that must be included in commercials for virtually all drugs. His point was that in a trial, if a patient gets a headache, the only way not to say it may be a side effect of taking the drug is to run perhaps millions of dollars worth of trials to prove it doesn't cause headaches. It's easier and cheaper to just say it may be a side effect. I would much prefer a simple statement that Drs. prescribing a drug should review side effects, and not list everything that was seen during a trial, but the regulators don't see it as I do.
The FDA ought to be in the business of finding the products that benefit patients with deadly and debilitating diseases, once they see it, at minimum an EUA should permit it's purchase while further data is developed to warrant full approval. If that were the case with DCVax-L I believe at the time they halted the trial they knew enough to issue that EUA. At a minimum the FDA, or other regulators, should review what's happening in a trial after each 3, 4, or 5 year increment to determine if enough is known to issue an EUA. Liability should be limited when a product is under an EUA as both Dr. and patient are taking added risk to potentially gain an added reward.
No trial should be permitted to exceed a decade in length without some sort of regulatory review that could result in at least an EUA, and perhaps a full approval based on the benefits being seen. It shouldn't take a million or more pages to see what's right in front of your eyes if you really look at how patients in a trial are doing.
Gary
Approval in the UK should end this argument, once that occurs the other regulators should fall in line, but it may wait for the EDEN unit to be accepted for commercial production. People who criticize the the trial fail to realize how much was learned, and how much the regulators became involved in redesigning it to look at OS and ignore the PFS goals flawed by pseudoprogression.
Gary
No, they have till about the end of this week to file or ask for an extension. It may be today as others have filed today, but they can easily get an additional week by asking for it.
Gary
Just yesterday, Nature published an article on NWBO's DCVax-L and Poly-ICLC, which had been seen in draft form about 8 months earlier. If you figure it took several months to create, you should understand that Journal articles that are peer reviewed can easily take over a year.
Gary
I don't believe that the company was responsible for the Nature article, they certainly should be able to display it at ASCO, etc, but I don't think that they can PR it.
The next news we get will either be the quarterly or UK approval. The quarterly could come as early as today.
Gary
If investors don't get shares in both, and if substantial equity doesn't come in to the company, it would almost guarantee a lawsuit by investors. You can't just give away the company assets and get nothing in return.
Gary
Up 50% this morning, anyone know why.
Gary