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We went through this last summer, it seemed the obligations were met. Now you’re doing a rerun. This gets so f’ing tiresome with your constantly rerunning the same nonsense over and over and over again.
NWBO had absolutely nothing to do with this event being closed at all.
I look forward to it. Also, I make no claims that someone might not have a reason to just go ahead and buy or sweep
advent into a company, even NWBO. I do not think they have to do it, but sometimes it is just easier and the nice thing to do. These are folks who have worked hard on this project. They have received shares, so that is probably the fix there. But even if a third-party did that, it’s not theft from us. It’s just likely a way to sweep that talent into the firm or overall project. Talent is talent. Sometimes it is difficult to come by. They would not have to do it. But, depending on the circumstances, it might be the nice thing to do.
But I honestly don’t see it. I just don’t want to be absolute.
There are always these miracle cures for cancer in test tubes. I think there has been a cure for cancer out of Israel that will just be 5 years almost every year since I have been conscious as a human being. Lots of great headlines, but one must look at the core concept, that it has a means to be consistent with the way the body works and immune system works and we happen to be in the sweet spot.
In that context you describe, it’s an approved drug, prescribed by a doctor which is off-label. But they will easily extend the label after approval. It will take a while, easy compared to past hurdles, because of changed laws and regulations.
I have no worries about this because they have had shorts on their back since Cofnate, got scrutiny from the SEC because of complaints from shorts, put in additional protections in terms of contracts and the contract they have in place was the base contract from Cognate as this was a subsidiary. Typically extending such contracts is very simple and the terms described and the baseline contract when I reviewed the old contract were exactly the same. Obviously you modify the new details and you address things like new costs and inflation. This development occurred in NWBO’s facilities. It’s a positive that they have commercial manufacturing not just approved, but can manufacture and provide DCVax-L under the UK Compassionate Use “Specials” program.
You clearly do not understand how biotech works. If they set-up the factory without a CDMO, the costs would likely be even higher. In this instance it is in their factory, these are contractors, so benefits and other issues are on Advent. Further, because of the easy regional development authority financing of Sawston’s development, NWBO has responsibility to sell services to other companies. Advent is doing that and effectively the facility can be subsidized by whatever business comes in.
The fact is, it is modular. Those employees are on the payroll of Advent. There are set costs which NWBO would have no matter what but because of the lease and possibly other factors, for Advent, costs can be spread potentially to other potential customers and NWBO being the owner of the key infrastructure and facilities, benefits. It’s a win-win-win for the companies and the region.
The fact is, traditionally, in the past, companies needed their commercial manufacturing facility set-up up front, and this cost billions of dollars in the earliest period of development of such companies. CDMO’s allowed those requirements to be eased, for specialization and know how to be aggregated and for costs to be shared to some degree amongst developing firms. They did not need to create full fledged factories before their clinical trials even started. Costs like that were horrible. I recall a friend telling me about his experience with a blood substitute company early on, many years ago. Now the product may not have been ready, but just to get to clinical trials was an ordeal.
You complain a lot about Advent, but the reality is that it was Cognate’s subsidiary and she got it as her payout when CRL bought Cognate and it allowed for immense flexibility and symbiosis that benefits everyone. Further, the regulators understand that it is a modular relationship and not what shorts claim, and to them, their understanding is what matters, not the ravings of people on bulletin boards who trade the stock up and down and praise and then complain depending on which way they are trading this week.
Partial.
No, they do not need Advent. Advent is a contractor and a smaller version of Cognate, which is a contractor. The contracts of these companies and Advent and Cognate are drafted intentionally to be modular and replaceable. There is a term for the replacement of either internal employees hired to do the job or another firm, doesn’t matter. Completely modular deal.
As for a larger firm buying, they can just as easily buy out employment contracts for any employees that they want.
Your notions about where the value is and what is what are completely out of kilter with reality. You’re repeating short narratives that have no commercial reality.
I completely agree HB4C! Well said!
It’s percentage. You said a higher percentage. The percentage is the same. Of course if you go to trial and get a larger award it is a “higher amount”. The percentage is the same. It is set by law. They do not take less, regardless of when it is settled. Of course states have different rules. This is NY State.
No, the partial halt started in August of that year, late in 2015, not all of 2015. And it doesn’t say they stopped enrolling as of that date. It says the last 17… they did not need to expand the trial arm with basically no placebo arm… this is why they have an external control arm with many, many times the number of patients they could have enrolled.
And yes, likely with the advice of counsel and the regulators themselves, they waited for the FDA to roll out reformed policies that would make the pathway easier. They could have rushed it under the bad policies of the past, but that would have been immensely stupid. We were all here to watch all of it. It was immensely skillful and showed great thought and strategic foresight.
And yes, if you’re going to run a trial for OS, you actually have to measure SURVIVAL… that’s why it takes long. You don’t seem to understand what is going on here.
No, it doesn’t say they stopped from that day, it says they did not enroll the last 17, which was an expansion of the trial as well as the placebo patients.
As for the starting context, it was not with you. You jumped into the middle of a conversation not about “judging” others for lack of patience but discussing that some investments are better for different people and this investment is not for everyone. You took virtually all of it out of context with your diversion into the esoteric nature of short term trading volatility rather than understanding that this stock of course is wildly volatile and it can go way down, hard and fast, on any given day, or way up and sometimes it is up over a long time given the nature of early stage bios, where little happens over long periods of time.
Here below is where this started, not where you falsely suggest it started. How much more noise are you going to throw up here?
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173739383
OK. Sure.
Celator Pharma. CPXX One of Adam’s predicted too small to succeed pharmas that succeeded.
They were $1.35, news hit. The swung wildly from there to the teens. Within a few months they were bought for $30+.
This notion that because NWBO at the moment is where it is at, it caps the possible price, is nonsense.
It all depends on a range of factors. At the moment the price is where it is at. But that doesn’t mean that things cannot change rapidly.
It’s exactly when I said, and they said only after August “the last 17”… does not say no more patients were enrolled after the hold.
You really did not say anything new you just linked to an earlier PR, than previously.
And it focuses on the events.
This confirms what I said and what I said was consistent with the final outcome. They had enough patients to complete the trial, and they were not told the final patients were either treatment or placebo, just the last x number would nir be needed, the end result was that they had their original trial number, no additional placebo patients. They effectively completed the trial, and they were then waiting for the final events.
“To date, the regulators have not agreed to remove the partial hold, but have allowed all of the patients in the Trial to continue being treated in accordance with the Protocol. The Company is pursuing ongoing dialog with regulators. However, at this point the Company believes that the potential benefits that could be obtained from enrolling the final 17 patients would not be worth the time it would take, as the process of re-starting and re-training the sites (including through Institutional Review Board renewals) for further enrollment would take months, followed by further months for the recruitment itself.”
No need to expand the number, no placebo, though they were not apparently told the arm was not fit for purpose they likely knew enough to know that they had a lot of crossover patients, a hallmark of a successful drug that virtually all patients desperately wanted to take even upon recurrence. And they had known about the problem with pseudoprogression, so also likely that there would be a challenge with patients being diagnosed as recurred under the old standard measure for recurrence for that part of the trial, but the secondary measure was mOS. So before being unblinded they did adjust the trial and they had extended the time out for OS anyway, for the long tail survival arm anyway, so that made the most sense, and of course they would also know then to discuss with the regulator the need for the external control arm to have a statistically vigorous measure for OS.
Contracting that out to a truly blinded, highly respected third party statistical and epidemiological team was a very clear effort to address any concerns about bias, to inoculate any final result for purposes of regulatory discussion and review and further have a result that regulators could reasonably consider as valid, though other drugs approved for gbm had far less clean statistical and other issues. They bent over backwards given what they knew up to that point.
You really did not say anything new. They made an incredible effort to get this to where it is and to get approval to be providing it through the specials program even now, is amazing in my book and speaks to the respect the regulator in the UK holds them in.
I do not necessarily think additional bells and whistles for manufacturing would hold up the application, though I know that is a much stated opinion.
I do think they are going methodically with MHRA because the agency seems way more enthusiastic and friendly and that will be a good way to set-up other applications.
I do not necessarily believe there is any higher barriers or likelihood of problems at FDA, but I do think the MHRA process has been so much friendlier that they will have a very good idea ahead of time to avoid challenges at FDA. And of course they know there might be trolls in wait seeking to undermine or slow their progress and I think they may believe those trolls would likely be far less influential once they are already approved elsewhere.
The attorneys get the same percentage whether they go to trial or not. Plaintiffs don’t pay a lot unless they think things are getting real. It doesn’t mean everyone will wait to settle until actual trial, and for some, discovery might not be a worry at all. But for some, that could be the key event or unflattering info could come out then and make settlement at all costs better than going to trial. Timing is often valuable and waiting is often the best strategy for getting anything valuable.
The FDA has certain timelines. The delays had to do with the trial and costs and challenges putting together the case for approval given what they already know are criticisms from certain corners. That is not FDA delay.
But I did not give you a timeline for FDA. They have not applied to FDA yet.
I just don’t count litigation spoils before the litigation happens. If of the parties settle before discovery or trial, that might be good, but also the company has to decide if maybe not settling will reveal things that will make them want to settle even more and for more money.
So I would not count that money yet.
Shareholders are not suing. Lawyers get 1/3, company pays court costs for suit in some way or other, I believe as well, filing costs and such, very minor.
Hi Gary!! Thanks for the post response.
I think if they get MHRA approval, which I believe they will, then FDA approval also is highly likely. I don’t see the FDA rejecting this treatment. It’s extremely safe, very natural in terms of not manipulating oncogenes or similar tactics, the data is just too promising and there are too many top doctors backing it, with of course as always a few back benchers with their own interests at stake on the sides complaining about “more research”.
I never bank on lawsuits. I have friends who have invested purely on lawsuits. It has never been a super fruitful way to get a benefit. I am hopeful about the lawsuit, I am not banking on a huge amount or necessarily a satisfactory one. Do I think NWBO deserves it? Absolutely. Do I think they should get a huge payment for the damage done. Yes. I simply don’t have a lot of faith in making plans around the benefit to an investment based on lawsuits until I see it. There are just too many factors that delay things.
I believe they have a winner treatment, and I am hopeful that BP will join in on the effort seeing the almost miraculous results of DCVax-L and Poly-ICLC alone. I do think other drugs could boost things even further, and it is hard to see other companies not also seeing that.
Lawsuit monies would be gravy.
1) it is a partial clinical hold;
2) the PR is not for a few years into it, Feb 2017. The news I believe broke from Adam in August of 2015 or so.
And as I said, we saw that the treatment arm was fully enrolled. It appears to me the meaning of that was intentionally unclear from the regulator so as not to spoil the trial, which is their duty, though their imposed crossover arm caused the depletion of the placebo arm to the point that it was not useful (fit for purpose). So the decision to stop enrolling that arm was a good one, but the challenge is in the nature of notions around clinical trials and their validity, which the regulators are working hard to address, to the consternation of traditionalists who have benefitted so far from the rigidity of things and their alignment with larger, well-funded companies and research programs.
I did not bring up the partial halt, and you did it again. I am just responding.
You said it was a halt. There were patients I understand still in the process of enrolling and we do not know the details of when and what patients enrolled. What we do know is they were only short placebo arm patients. I have explained what I think that means. I expect they had many discussions with regulators leading up to their creation of the external control arm.
I think if you were serious, you’d not be arguing with longs on any bulletin board or social media, you’d be long gone and happily invested elsewhere. The mere fact that you are here arguing in the manner you do speaks loudly about complex motives inconsistent with the notion of a long investor looking for success here.
The fact is, what you are arguing about and bringing up is now long irrelevant. What is relevant is there is an application pending with the MHRA for marketing approval, but you want to discuss things long past, which is typical of a short with very little to say.
We do not agree. Oil and water.
I am not exactly sure what you’re initially saying but the history is the history. It has nit been a mystery for a good number of years now, as you point out, yet you’re still here posting… strange.
We do know there was a financial crisis which caused a financial pause. We do know they had early capital issues and LP came in and helped to address those issues. We do know there was PARTIAL halt, not a full halt and enrolling patients were still enrolling. Your statement there is not fully factual, and what we do know is they are short placebo arm patients, not trial patients which says quite clearly to me that they were not allowed to enroll more placebo arm patients but since the trial was blinded, they did not know this was the reality. That seems obvious to me, the placebo arm was not fit for purpose and we know there were no safety or other issues that necessarily causes a “Partial Halt”….
We don’t disagree on “reasonable time frames”, the time is the time. There is no such thing. If you did not like it, why are you still here.
And again, I point to REGN, 20 years as well…
Bio
I am not trying to get into another argument . 1012 years ago was at supposed very end of phase 3 enrollment at that time the way it was portrayed . By no means that will be considered too early. Partial hold was in 2015 and no new patient obviously enrolled after that . And we are approaching a decade from that . We can leave it at that we disagree on the reasonable time frame for these events that normally occur and what patience means . People can read and judge for themselves and they can go back and read the posts from 10-12 years ago and see for themselves what time frames were being discussed and implied etc . No point going to and fro
Likewise, I think that describes you to a T. You sound like you’ve only ever worked at the piddly level.
I did not Google. And I’ve made my points, they are clear and I have no doubt that many in the professional financial world would agree with me. You posted investopedia… so quit it with the “you googled”… and as I said, I actually did not google.
I never said “this is normal” and I clearly do not claim to be an expert. Yours and the attacks of others are simply because you’re not very good at making your own good points. You attack instead. Try to make some good points.
I have explained that you have to have a strategy to invest in these stocks. It should be a portfolio and no, I generally but not always, but generally don’t invest early. The only people who should be investing in spanking brand new technology like this on those first rounds are, in my opinion, professionals and the core team, their contacts in firms that fund such companies.
I have already told you I do not think k these are ideal for retail that do not understand this sector, and that taking time to understand is critical. You also can’t get much experience without dipping some toes in the water. That is why you have a portfolio, not a single stock portfolio, at least a few investments you can follow and manage and probably also an index.
The feeling is mutual. I note when I comment on your posts I get downgraded by whoseholdingthebag… any connections?
Or less.
Agreed and a surprisingly agreeable exchange. Shortbread does indeed produce crumbs. :)
Advent is irrelevant and not the topic. Dilution is a requirement up to commercialization, and even to kick it off, but they have done a lot to have it ready for production on approval, at reasonable cost. Hence shorts have to squeeze the price to increase the dilution… they have no choice and it costs them little to do it. This is the genesis of the problem but also common to such companies and circumstances, not unique to NWBO. Management is not going to magically transform reality, and anyone experienced in this space knows this. They might get a deal or start doing deals but even those can be dilutive. Depends on the terms.
But dilution is not all bad, it’s just a reality. And they have a very moderate burn rate and seem to be working very inexpensively to get this across the finish line. The price decline in my opinion, despite a number of posts claiming so, is not all about dilution. But obviously it would be nice if they did not need to do it.
Certainly could have found a transcript. Since others were discussing it, it seemed reasonable to ask them to post exactly what THEY were discussing so that there would be no ambiguity or false claims that it was not THE specific language they were referring to, etc. You know, to avoid engagement with some of the sleazy things that some bad actors might do when they deceive. Have to be careful and ask for people to back up their claims.
Note that I also asked a fellow long about a point made.
No real argument with my point however…in your response.
Regardless of your view, your characterizations are not accurate. They show you consistently do not understand the context or the technologies or the way companies organize their efforts in this space.
Validating deals will need to happen first, or no sale. They are not selling at squeezed prices, while shortie claims it’s a scam, and markets don’t have a clue.
I appreciate that, but I think there was an animal study only at that point and it was not originally a part of DCVax-L, and I do not believe they adjusted the formula of DCVax-L, and there is no indication of a 4th drug in the combination trial. So I think the Daiichi drug is yet to be included in a human combination trial.
It is very promising, but I don’t believe it is yet part of any human trial with DCVax-L. Do you have anything more conclusive re the combination trial?
Oh, I see, you’re saying the next SPORE trial will include. Yes, I agree with that.
Thanks ExW.
I don’t think that means what people seem to think it means based on what sounds like were superficial reads.
Does sound like a general ballpark and it makes sense if you’re growing a portfolio of potential drugs with great prospects yet unproven, and further the conversation, related to Daiichi to collaborate also has critical substance as well.
But as for buyouts, it’s always about the product, its capability and what the sellers are willing to take for it if they can control the sale and the acquirer doesn’t want the mess of a hostile takeover, which BP typically doesn’t really want with these small drugs with complex issues around transfer.
Interesting but not as dramatic as some make it seem. Reasonable targets for Merck to enunciate.
Transcript?
Great list of interesting factors to keep in mind Flipper.
I am aware of the benefits and opportunity with PLX-3397, and it was one of my earliest topics here relating to NWBO and Daiichi. But I was not aware that it is a key constituent in this cocktail. What is the source for this?
“9. PLX-3397 is a key constituent in UCLA cocktail DCvax-l + plc-3397 + poly-iclc and sometimes Keytruda.”
Beta is a flawed measure for penny stocks like this. It only takes ONE measure per month, over that 5 year period and we are closer to where we were 5 years ago now so it looks artificially and falsely less volatile.
I find these trading measures often not a lot better than astrological predictions.
But some measures that are suggested for penny stocks are:
Average True Range (ATR): Measures the average daily volatility of a stock.
Standard Deviation: Similar to ATR, but based on historical price movements over a specific period.
Sortino Ratio: Focuses on downside risk rather than total volatility.
Price-to-Sales Ratio (P/S): Can indicate overvaluation in penny stocks with limited profits
The point further is someone who bought a few hundred thousand here at one point might find their investment at a hundred thousand at one point or a little more and then over a million. And then back down again. Most investors seek steady market investments in commercial companies because they have steady income and that range is far more predictable.
I am not recommending anything, just pointing out the weakness in using the beta measure for a stock like this, it is useful sometimes and sometimes less meaningful.
And for investors, it is the potential and opportunity they are buying, so if they are satisfied, then the objective is to buy low and ultimately to sell high, so that volatility can work quite favorably for knowledgeable investors who are willing to embrace the risks of microcap biotechs and their long timelines.
It is the epitome of capitalism to invest in the small guy and see the business become a major economic, commercial and scientific force.
But small companies are less steady ships on a big ocean.
Your definition for traders is not applicable for retail or long holders of shares like this in small penny stocks like this. You can preach all you like that it’s not volatile, but it literally defines volatility for regular investors. Your hot air is wasted.
Yes, I do not think short term investors, people who cannot do the due diligence satisfactorily for themselves should be invested in stocks like this. It is a great opportunity, but small penny stock companies and even on large exchanges these small biotech microcaps always carry a great risk of loss either due to product or corporate failure, or loss of nerve or need for money by small investors. So everyone needs to determine if they can wait these companies out, follow them intensely daily and understand what risks are unrecoverable and what are just noise or life-cycle or larger macroeconomic risks, etc, and then they need to make clear, rational decisions, which is typically difficult ultimately for most investors, which is why generally people are typically advised to focus on indexes, which simplify the analysis to some greater degree.
That is not what Captains posts mean. They show dilution, not personal sales.
Say what you want, fluctuations this large in price are volatility for ordinary investors. What happened on May 10th way back when was textbook. Yes, it is a single product, slow development product. It doesn’t change the fact that for investors of every type, the price is very volatile to hold and can go from one extreme to the other and back again in fairly short time. Blue chips, most investors expect and hope and indexes tend to move slowly, with the markets the follow, and fluctuate way less in valuation.
These are stupid arguments and you know it.