Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
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
Thanks, that's what I thought. Let's hope that once we get approval this will change, and if not it will change once we're on a major exchange. I don't know that it's required by exchange rules, but I can't remember a company that hasn't done it.
Gary
Not being an attorney I'm wondering if any who are know just how many more times the MM's can file their MTD and Posner must answer before the judge call a halt and takes the case to trial, or settlement. I feel like the MM's legal team is working in much the same way at Trump's legal team to delay at all costs. I know that Trump isn't the only one who seeks such delays, he's just the highest profile one. Frankly our judicial system works practically as slowly as other regulators, like the FDA.
In recent days I've heard of at least a few Drs. who're getting experimental treatment for deadly cancers. I really wonder if developments wouldn't be substantially accelerated if some of these people were asked to participate with the FDA and other regulators in making their decisions. Even if they've managed to get the experimental treatment of their choice, I believe such people could get the regulators thinking of ways that they could expedite getting such treatment to patients. Why not do what was done with Covid-19, issue an EUA which allows the product to be sold, and covered by insurance, while full approval is being evaluated.
Gary
Thanks, I know I'm not a technical expert, I really don't try to be, but I do like the roll of devil's advocate, stirring up some discussion that perhaps we all can learn something from.
I really believe that NWBO has the potential of being the best investment of a lifetime, but nothing is ever guaranteed. For me, and I believe most longs here, just UK approval will make it a good investment, more than a double, perhaps a five banger or more. I believe that's tiny compared with how big we could be, but that alone would be success for many of us here.
Gary
Pegs, while that would be spectacular if done without an R-S, I could live with one if it is not too severe. The goal of getting on a major exchange would make this a very different company, that's what I want to see.
Gary
Some people enjoy my dissertation. Others don't. Feel free to ignore me.
Gary
When I recently invested in the company it wasn't in the belief that they had the cure to AD, RETT's, etc. I believe that these, and other diseases are rather like cancer, you keep coming up with new treatment that improves on the old, but no magic bullet is coming along that simply cures everyone. In my opinion we're making improvement in the treatment of these and other diseases, not a cure, but an improvement that could become a part of the SOC for a significantly long time and should bring in multi-billions annually once they're accepted.
I don't know if the company will exist after multiple approvals and billions in sales, or be bought out, but either way, investors should be well rewarded. The key is getting that first approval.
Gary
Our current market cap is under $600 million, hardly what would be expected for a company near approval of a potentially blockbuster product being approved near term in the UK. The question is, what should our market cap be after UK approval.
Personally I can't imagine anything below $2 billion, but expect it could be much higher in the $5 to $10 billion range. I believe much depends on the media coverage we get on release of the news, and then on what's planned to follow it.
I've not spoken with DI for some time, however others who have make it sound like far more than UK approval will be rolled out after the UK approval. Certainly we can expect the announcement of an Annual Meeting. Is it possible we'll also get news of submissions, or planned submissions to other regulators. An EDEN update certainly is possible, could we be closer to its acceptance than we think. New trials should certainly be in discussion in the not to distant future, perhaps in partnership with other companies.
My point is that depending on what's rolled out, and the timing on all that should be happening during the remainder of the year, our market cap by years end could be as low as a few billion to as high as well into double digit billions. Unless some country piggy-backs on the UK approval, I don't know that we'll have additional approvals this year. As a guess, if anyone were getting in on the UK approval it could be the Canadians given their close relations with the UK. I would suppose the same could be true of places that weren't involved in the trial, but are closely related to the UK, like Australia. Not everyone would wait for the US approval to act.
The market cap today certainly indicates that few who know of NWBO believe the approval is that near, but when it happens they'll be proven wrong. I suspect that most of the new investors who invest on the news of approval will not have heard of NWBO before that day. If media coverage is strong, and investment becomes emotional, no telling how high the market cap could be taken by investors who look at a stock based on its price, and not its market cap. A $20, $30, or even $50 stock sounds cheap if the headlines say the technology may be applied to all solid cancers, and frankly it could be cheap after it's proven to work in most solid cancers, but in looking at the shares outstanding it's not justified by UK approval for GBM or even all brain cancers alone. It's never been my intention to sell the majority of my stock, but if emotion takes over and carries the stock well over a $10 billion market cap, I believe many of us would be either selling, or placing trailing stop loss orders to guarantee tremendous gains, and looking to purchase substantially more stock after a healthy retrenchment.
There have only been a few times in my life that I can remember such buying on emotion, the biggest was based on a NY Times article on Judah Folkman that took a company from $1 to over $100 on curing cancer in mice. I'm not saying this could be repeated here, but in that case, it cured mice, not people, in our case, over time, it may be found that our vaccine does provide substantial benefit for patients with many forms of solid cancer and over time that should justify triple digit billion market caps, or more.
Gary
I have been told previously that Journals give days to weeks notice, not months, if true it should happen this month.
Gary
My stock addition is about 40% of the volume today thus far. I frankly have no idea how many shares I will end up with when all the dust settles, but I think it will be worth more than I have invested to date.
Gary
Out of curiosity, has NWBO always just dropped their quarterly and Annual Reports, or in the distant past did they announce when it would be released. Back when they were on the Nasdaq, did they also do webcasts when the quarterlies occurred.
I don't believe that what they're doing now isn't legal, but other companies call attention to themselves by announcing when the financial reports will be issued, and of course most of them follow it with webcasts to discuss it. Let's hope it's not too long before we're doing it that way.
Gary
Any feeling for whether the company will provide a quarterly report this week. As I see it, the quarterly should be independent of what's happening with other things that are happening.
Gary
I believe the moderators should sticky this post if the company fails to PR this presentation shortly.
This is really the sort of thing that should be PR'd by the company before it's discovered by investors, unless they're embargoed from doing such things until some date.
I wonder when there intentions on ASCO will be announced. I still like our chances of approval in the UK before ASCO starts.
Gary
Great find, hopefully we'll have the UK approval before the presentation.
I wonder if it's possible for the company to put the presentation on their website after the conference ends.
Gary
No, she started with a rare form of kidney cancer that normally is very deadly, but was thought cured after 10 years. She had some good years before it returned with a vengeance. I hoped that DCVax-Direct might be available in trials, but clearly it didn't happen. She did have surgery, then substantial chemo, but she refused additional surgery which might have given her more time, but couldn't possibly be curative.
I've recently had a few friends choose quality of life over duration when it came to treatment they'd accept. The beauty of our vaccine is that it offers both quality and duration, especially if the right other therapeutics are combined with it. I often think that drugmakers fail to emphasize the quality of life with their products when they're not found to extend life more than the SOC but in fact are easier to tolerate for the patient.
Gary
I may be mistaken, but I believe you file for approval. If the regulator conditions the approval to requiring some further confirmation in the future, you except it. It might be different if you're going for approval out of a Phase 2 trial, and already have a Phase 3 trial running, but I wouldn't want to propose doing another trial at the time I was asking for approval based on the Phase 3 I'd already run.
I'd be more inclined to suggest that all patients receiving the product post approval reported the outcome into a Phase 4 database. I really believe that should be the case with all new products, then problems with products couldn't be hidden behind settlements with non-disclosure agreements.
Gary
Flipper, it would seem to me that an mRNA vaccine that was intended to prevent the onset of cancer, or used on discovery of cancer prior to surgery could be beneficial, likewise once the cancer was detected DCVax-Direct could be effective prior to surgery. Once surgery occurs, I've got to believe that a vaccine that's made from that specific tumor would be more effective than an mRNA vaccine.
I'm certainly not an expert, but this would seem like common sense to me.
Frankly when my wife was determined to have breast cancer, over a quarter century ago, I was surprised at the time between discovery and surgery, it took months, and today it seems no different. I believe that treatment with DCVax-Direct could be initiated within weeks of discovery of an operable tumor, and should be injected into that tumor well before surgery. The greatest benefit of such treatment would hopefully get some anti-cancer action into the mets which left untreated can result in the cancer returning years, even decades later in multiple organs. If the mRNA vaccine could potentially do the same, perhaps both should be used.
If the mRNA vaccine is given as a preventative to cancers, like many other vaccines we all take, once a cancer occurs in a patient who's already had the vaccine, I don't know that more vaccine would have any effect whereas both DCVax-Direct and L post surgery should be effective. We know that by themselves they're not curative, but other therapeutics become more effective and lives are certainly being lengthened and at some point the cancer may be determined to be cured. I frankly don't know if all the longest living patients treated with DCVax-L are considered to be cured. It's been 10 years since I had stem cells for leukemia and I still return to City of Hope quarterly to determine I'm still in complete remission, I cannot consider myself cured as long as my Dr. still believes such testing is necessary.
I should note, my sister was thought cured by her oncologist until a body scan done by her new internist found tiny tumors in several places that ultimately proved fatal, it was roughly a decade after the initial cancer was treated. I don't believe the old sentiment that after 5 years cancer free your cured is currently considered the SOC for most cancers.
Gary
It's interesting that Dr. Liau is not yet speaking about what happens when DCVax-L is combined with other therapeutics. I believe the reason is based on the formalities applied to clinical trials in which nobody speaks officially about advancements until they've in some way been presented for peer review. Let's hope that happens in the near future.
To my way of thinking the entire process of developing new products takes entirely to long. While a company can release a TLD statement, it's very general, just an overall impression of what they've seen, and as we know the peer review can take a year or more before either Journal, or acceptance at a proper conference occurs. How many lives could be saved if the regulators really got into what was seen in a trial and if justified did an EUA to make the product available while all the formalities of peer review and formal filing for approval, often in excess of a million pages, is done over what's often in excess of a year.
It's not that no data has been revealed from the trials at UCLA, interim results are spectacular, but in a formal presentation by Dr. Liau, she's apparently not discussing them. I feel certain that if she were treating a patient with DCVax-L they would also be receiving Poly-ICLC. I don't know if the company is permitting her to treat such patients if they're not officially in a UCLA trial, though she clearly knows how to make the vaccine herself.
Yesterday I saw a neurologist because of essential tremor, which is hereditary as my father had it. While she doesn't suspect anything, she's having me do a brain scan, which I've never had previously. While I've been very pleased with City of Hope, if there we a problem requiring surgery, I'd probably try to go with UCLA and Dr. Liau if possible, only because of the after surgery treatment that may be available there, and nowhere else, at least right now.
If the EUA were used more frequently, I would suspect the regulators would have had sufficient evidence to do so back at the point where the trial was resumed after the halt. I believe the German's insisted that all get the vaccine because they clearly saw the benefits, and the others did come over to their way of thinking. I suppose the other aspect of using an EUA would be having a production facility that wasn't fully approved for commercial production, but was qualified to supply pivotal quality trial material. How many tens or hundreds of thousands of patients might have been benefitted if an EUA had been done back then?
Gary
I don't know if anyone knew the size of the trade, anyone see it?
Gary
I am still curious about the after-hours trade on Thursday. If the trader does have some information, it would have been normal to believe it would be released on Friday. The company, on the other hand, should know that good news is best released early in the business week and does have the flexibility to do so.
If there is anything to this Monday, it should be very interesting.
Gary
We know they have St. Gobain's Glass for production of the disposable cassette, I believe they can produce virtually any quantity that NWBO wants. In terms of the EDEN unit itself, I'm sure that several companies would be capable of either building the entire unit, or building components that the Flaskworks personnel could assemble, test and certify.
I believe the EDEN units will be leased to those authorized to make the vaccine, NWBO will be responsible for all maintenance and upgrades, and I think they'll track each cassette to the machine that makes the vaccine and it's proper disposal. The question is whether Flaskworks will assemble the EDEN's from contracted components, or just certify each unit prior to delivery to the producer, and then maintaining and updating it as applicable. I think that Flaskworks will be a profit center of it's own.
Gary
Thanks, I think I may have after hours authority at Fidelity, but didn't think OTC was covered, clearly it is. Pink's aren't, and that's fine with me.
Let's hope that purchase is based on someone knowing something. The other possibility is someone put in a market order after hours and the MM's took total advantage of them. Market orders have risk anytime, but after hours I believe you're exceptionally vulnerable to MM's playing games as practically no trading is going on, especially in a stock like NWBO.
Gary
I didn't know that you could buy after hours on the OTC, but perhaps on a foreign exchange. If this is real, someone knows something.
Gary
Doc,
To my way of thinking, the real question regarding production of the vaccine is what the capacity is for whatever company, or companies, is for making the EDEN units and disposable cassettes. I don't know if estimates that some made of the EDEN costing tens of thousands each when mass produced, but if true, well over the cost of making it is returned in the first batch of vaccine that's made in it. I believe that if worldwide demand were a million batches a year, we could find, or build cleanrooms capable of supporting 20,000 EDEN units which at 50 batches a year give us 1 million batch capacity. I suspect that CRL could house all, or most of the EDEN's in existing facilities they have worldwide that already have cryogenic, and other support needed.
I would think that if the demand is there to build 10,000 EDEN units a month, at the right price manufacturers will materialize who can do it. I'm not saying that many are necessary if production proceeds approvals, but if substantial numbers don't exist at the time of approvals, rapid production may be needed, especially if off label use in other solid cancers is available.
Gary
In roughly the next week NWBO should issue their quarterly report. Unless we have action from the UK, it's doubtful if they'll say anything beyond the filing there. I believe that if they wished, they could gain an additional week if they thought there would be more to report in the additional week.
As of today, the 150th day is just under 3 weeks away, the company certainly knows if they got an RFI or not, which would give them a clue when they should hear from the UK, but I doubt they'll say anything unless they have something official from the UK. As for anything new on the EDEN, perhaps if something worthy of discussing has occurred, we might hear of it in the quarterly.
To me it would be big news if they broke their tradition of only releasing the formal report, but no webcast, if in advance they PR'd a quarterly release coming on a specific day, and a webcast very shortly thereafter.
Gary
I don't believe that has to be true. Remember, I'm not saying for every trial, but if the DSMB or lead clinician believes such action worthy, it could take far less action at that point to make such a decision than waiting years and reviewing applications that run to over a million pages. I believe a fairly small panel of expert Drs. actually seeing what's happening at key trial sites would take a smaller effort than evaluating a BLA or NDA as applicable.
Gary