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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
When you have a problem, you can work on a resolution, when you resolve it, it's gone.
When you have a non-problem, it can never be resolved.
The vaccine made at UCLA not being DCVax-L is a non-problem, no matter how many time it's demonstrated to be otherwise, someone will bring it up again.
We have many non-problems here, many are bashers, some may be short themselves, others being paid, they cannot handle success, so I expect they disappear with an approval. The MM's will become another non-problem when Posner's finished. These things don't happen overnight, but they happen and eventually the non-problems disappear but new ones appear to replace them. When DCVax-L is approved by the regulators no one will care if someone makes the allegations that bashers here do, they'll know better, it may take awhile, but not all that long.
Gary
I agree, but we really need to get the audited data to really know what we have.
If you've seen the Waymo, I've got to believe that other sensors can be built into a car that could do what those on the Waymo do without being major features on the cars, which are Jaguar's. I suspect that all the whirling gadgets on the cars are more to gain attention then necessary functionally, though they probably have a function. I'm only saying the same function could be achieved with tinier devices that could be largely hidden by trim design on the cars.
Gary
I've only owned AVXL a few months, but I've never seen a stock where more posters want to fire the CEO. The one news item that crops up weekly, sometimes almost every day when you hit the headline link here is, the Gross Law firm gathering stock owners for a class action suit. I really don't know how they do it, you can cure cancer and get a headline for a day, keep announcing you're suing the company and it shows all the time. Anyway my point is that companies and their CEO's get flak all the time while they don't have an approved product for sale. On approval these very same people will be toasted for their brilliance.
AVXL's market cap is much smaller than NWBO, but market cap doesn't put you on a major stock exchange, stock price does and while it's down some on recent news, it's well above the minimum for maintaining an Nasdaq listing. Like NWBO they're in peer review for a Journal article, and it seems to be taking forever. I frankly forget how many months our initial Journal article took, or just how many months Nature has been working on the next one.
My point is only that all companies where products are slow to approval get criticism and frankly it's progress that limits it, then approval, without that CEO's get raked over the coals regardless of whether they issue PR's, have quarterly webcasts, etc. LP probably gets less flak from us than Missling, AVXL's CEO, does, and he does quarterly conference calls, etc. I believe that both companies will be successful in time. I like NWBO's potential more, but if AVXL can play a roll in Alzheimer's, Parkinson's, RETT's, etc it too could be huge. I believe NWBO's success will come first, but in time AVXL's success will come, and it won't matter if they replace the CEO or not.
Gary
Has anyone seen, or taken a ride in a self driving Waymo Cab? I've seen many of them and frankly wonder if all the gadgets whirling around on the cab is really necessary, or merely intended to give the rider they're better protected than a car with all the censors found in many modern automobiles capable of self driving in parts of the streets and highways. I'm not suggesting that more censors aren't needed to be truly self driving everywhere, I'm just suggesting that they can be integrated into the car without all the spinning wheels, etc. found on the Waymo Jaguar's.
If I'm right, and if additional and improved sensors can be integrated into the car without looking like an alien vehicle, perhaps Core Optics will become one of the major suppliers of these improved devices.
I should note that all the Waymo's I've seen have had drivers in the drivers seat, but I understand in parts of L.A. they're available driverless, and I'm not certain if there is a charge for using them at this time. Tesla intends to be in this market in time and you can bet they won't have all the whirling gizmos found on the Waymo's, and I'd suspect the Jaguar's will be more comfortable, but the Tesla's will get you there.
Gary
Gary
I know I've made plenty of similar mistakes over the years. We all need to recognize that the potential here is great if we get just a small percentage of this total. As I gather it, the key is whether our technology is truly superior to others. If it is, it sounds like our intent is licensing it, not manufacturing massive amounts of it. If many of the makers of batteries licensed our technology that could prove more lucrative than manufacturing a small percentage of the batteries ourselves.
I'll be very interested to see the path that all this takes as the people at Core Optics take command. It's possible that they will want to change direction and push media production and sales, rather than licensing the technology to others. I really want to see the company come together and operate for a few quarters to really start to understand all that we have going for us.
Gary
I think many of us figure May 21st based on the submission date. We really don't know of formal acceptance though I know some people suggested a few days later. If we do have approval before ASCO it should certainly get us a great deal of attention there. I don't know that any peer reviewed submission was made for presentation there, but the Experts Theater presentation ought to get a lot of attention.
Should we not yet have a decision, I would hope the Experts Theater focuses on the development of the EDEN unit and perhaps some discussion of the compassionate use of DCVax-L in a variety of cancers in the UK.
I don't believe the filing was in any way timed to ASCO, but it would be great if it turns out that way. Remember, they originally announced the intention of filing much earlier and had two different announced delays, they certainly weren't intentional. I believe one reason approval is over 90% certain is because we've been working with the regulators all along, and such delays came about because of advice we were being given regarding what was in our filing at the time. It may have not come directly from the regulators, but remember, we contracted for much of the work in the filing. I've got to believe that our contractors also have excellent knowledge of what the regulators want.
The key is approval, how it's done may reflect on near term stock price, but will have little influence on the long term price of the stock. If NWBO isn't bought out prior to substantial revenue developing from sales, it's share price and buyout price if we get an offer will be based on revenue at the time, and forecast into the future. I was unhappy with the IMGN buyout because sufficient time hadn't occurred to understand how much revenue growth would continue to be seen. ABBV anticipated $2 billion a year, to me the $10 billion was far below what the company should have been worth.
Gary
In reality, the different regulators are doing much the same thing in different ways. The FDA provides a PDUFA date on accepting an NDA or BLA, it's normally 6 months after they accept it if priority review is granted. In the UK it's 150 days after the document is filed, plus the time it takes if they request additional information from the company. If no information is requested the UK process is faster than the FDA, and I believe they're shooting to do it in 120 days. I'm uncertain of the other regulators, but I believe they have similar guidelines.
Frankly it's to bad they can't agree on a common submission that all could agree with, but that's not the case. I've got to believe an FDA submission will have nearly every page in the UK submission, plus more on the commercial production facility, as that was resolved in an earlier submission in the UK.
I would hope that before the end of this year NWBO has filed with the three other regulators. That may be dependent on acceptance of the EDEN unit for production which is another major step. I would hope that when they have an Annual Meeting they'll provide guidance on this, and more.
Gary
CO, I wish it were so, however, I've been in companies that were turned down by the FDA before and they too must issue news on the negative news. In most cases new trials may be adequate to approve the product, but that's years and hundreds of millions in additional expenses. IMGN's Elahere was such a case, the initial trial demonstrated efficacy where IMGN expected it, but the FDA had broadened the target in designing the trial. When they ran a smaller trial where IMGN wanted it in the first place they gained approval, but had to confirm it with a larger trial, which was approved after the buyout.
A small delay would probably not require a PR, but if the company is notified of something that will require significant time to resolve, they will need to PR it. Certainly they'll put as positive a spin on anything that they can, but it will have to be announced. Many have reported that the 150 day decision period has a built in pause if more information is requested from the company, that's where potentially up to 60 days could be taken. One generally knowledgeable poster indicated that no RFI was submitted to the company, but I don't believe it's possible to say for certain that this is the case. The truth is, we'll never know about all the discussions the company has with the UK or any other regulator, I suspect that all companies communicate more than any of us believe they do.
Communication with a regulator isn't always fruitful. Genentech decades ago almost certainly spoke with FDA staff in designing a registrational Phase 2 Trial for Kadcyla. When they filed for approval based on the results, Dr. Padzur refused to look at the filing as he didn't like the format of the trial. I believe his staff got the message not to agree to new protocols without speaking with him about it, and Genentech spent a few more years on a Phase 3 which was underway, and would have been a confirming trial, to gain approval. Just another tale of the FDA holding up approval for years of a product which should be approved. I suspect that perhaps tens to hundreds of thousands of patients were prevented the benefits from Kadcyla because of FDA action, or lack of it.
If two weeks from now we don't have an approval, I believe we can assume that the company did receive a RFI and the delay will be whatever time has been required to deal with it. Meanwhile, if there was no RFI, we could gain approval on any day between now and then as the UK won't intentionally wait for day 150, they'll announce on making a decision. Of course we know, officially they post approvals twice monthly, but the company should be notified, and they have a few days to make their formal release. I'd rather see a few days delay, and get a release before the bell on Monday then if they immediately released on a Thursday or Friday as that's when they got the news.
Gary
I think if you read it more carefully, it's 54 billion. That's massive growth. The question is, what percent of that can we win.
Gary
If you have ever invested in a company that filed with a regulatory agency, you know that what you are saying isn't true. I have never had a company provide status unless action by the regulator required it.
Gary
If they received an RFI, the delay could be up to 60 days. That would put June and July in play. Anything more serious than that, and I believe that they must inform investors.
I still like the odds of approval in the next two weeks. If not, by July, if nothing is released by the company.
Of course, we should get a quarterly any day, and an update could come then.
Gary
I, too, lost in Genvec. I believe that if on announcement of approval we get a trading halt, the stock will open at least a buck higher than it is trading at the time. For me, that would more than make up for all past losses and put me well in the black.
I don't know how many shares others have in NWBO, but for me, I would have a position that is well above half a million. It could go to a million or more that day.
Gary
The only way that we can get a massive price in a buyout is to achieve a share price that is roughly half that price, or more, before the buyout. In our case, that can only happen with approvals and revenue.
The question at that time is, do you really want it, or would it be better for the company to grow independently.
Gary
With that being the case, the question may be, does adding either Keytruda or more of the Poly-ICLC during treatment improve the outcome, or is the key what's incorporated into the DCVax-L when it's made.
The big question that will be answered over time is whether the greatly increased T-cell production with your own T-cells is more effective than CAR-T treatments which may cure one cancer while creating others over time. Perhaps both are needed, but perhaps the risk from CAR-T can be reduced if lower doses are as effective when used with DCVax-L.
I don't know if improvements have been made in CAR-T that sustains it's effectiveness. When I discussed it with my Dr. at City of Hope who's done some of the pioneering work in its development, he indicated that it's only effective for a matter of a few days, if it doesn't knock out the disease in that time it will return in time. It was shortly after my stem cell transplantation that I discussed it, so nearly 10 years ago, I really don't know how much further it advanced since then.
While it's clear that if CAR-T is the only choice to cure a specific cancer it should be used even if it means routinely monitoring the patient the rest of their life for other cancers it may cause. On the other hand, if DCVax-L and Direct prove to be of equal or greater benefit, in time CAR-T might not be used at all.
Gary
Pqr, I know LP's an attorney, and a very well qualified one, but I believe this is largely Posner's fight and her strategy. I suppose that each MTD exposes more of her evidence, but she isn't going to quit answering their challenges. I'm still of the belief that this will settle before a jury ever has a chance to act. I expect it before they go to trial, but even if they get into it, I suspect an acceptable offer will come in prior to jury actions.
While on jury duty in the past I've met other jurors who were starting deliberations when released from jury duty on settlement. An attorney friend client took a nice sized settlement against my friends advise only to learn from the jurors that they were looking at number that were a significant multiple of what was offered, well into the millions. Of course there is the bird in the hands argument, if you don't take a good offer a bigger judgement may be appealed and no telling where you'll be in the end, or how long it will take.
I've been on juries that awarded millions for wrongful death, but as a juror you really never know what is actually paid, or by who.
Gary