You clearly have no idea what you’re talking about. A casual dive into that site tells anyone vaguely knowledgeable that this is not anything like the Flaskworks machinery or technology and that this machine does not manufacture anything like DCVax-L. You might be able to use it for prep before you then do the actual manufacturing of a vaccine like DCVax-L, but this is not at all what you think it is…

This machine is for separating DC’s not for a cGMP manufacturing process of a real clinical vaccine. This is for separating dendritic cell types and mixing them a bit, it has nothing to do with actually creating a state of the art vaccine for a manufacturing process. This is basically a clinical machine you might use in prep for a manual process like NWBO does now.

Did you even look at the brochure or the actual “machines”? Total nonsense.

No, they already have units, they just need a cGMP version. And this other company having their claimed units doesn’t mean they can make every product. Flaskworks had such units when they were bought, but to get the machines to the specific requirements of a particular product and the cGMP takes more than reading a website claim and equating the two…

More on general IP Protection, old post

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172826539

I do not consider myself uninformed. I think this is the obvious circumstance. Flaskworks will come along shortly. I think I also previously predicted how they would get it approved, that it would not require human testing or any of the things some suggested and that you would be able to do multiple different batches at once in one system. All things that caused my assertions to be challenged.

It’s looking very good and very exciting, and the patent process as well, is extremely exciting. These will become core and very important patents for maintaining ownership of the Lysate + DCVaccine pipeline. Others will not only need to create, and trial and prove survival numbers comparable to DCVax-L, but they will also need the manufacturing technology. NWBO can become a go to for vaccine inventors and a partner for commercializing such vaccines also, if they want to go that route and if there are new innovations that make that a profitable and viable route. But most importantly, regardless, they will have a solid set of patent moats to protect the company and investors.

Very exciting PR in my opinion!

Why do you throw out these patented lies every day? It’s really strange at this point.

Not news. And it cannot attack the diversity and reality of unknown and broad antigens like DCVax-L. Further, it will take them years to accumulate the survival data NWBO has even if it has some efficacy, which may be very unlikely given past efforts to attack handfuls of known antigens only. If everyone gets a different mix of different antigens, how do you even measure which human concocted version worked and which didn’t? Seems like a questionable endeavor.

And I previously told you why that would be a stupid move for any BP interested in a deal. It would trigger basically a hostile takeover and a bidding war most likely. It’s no way to actually invest for a serious potential partner as the money is paid to other shareholders and not the company and a negotiated deal can create rights and opportunities that buying shares on the secondary markets cannot possibly trigger. Given the extensive holdings of various persons and friends of the company, as well as other complex relationships that drive some crazy, a hostile buyout for cheap would be a grave mistake.

Excellent post!

Inquirig continues to illuminate the nature of Dunning-Kruger.

Don’t be so churlish.

Wish posting is not reality, as much as some might like to believe it. DCVax-L published peer reviewed results, has the backing of top doctors from top institutions in top developed countries and apparently a very friendly disposition pre-approval in the UK. It’s unlikely your wishes will ever become reality.

Great post!

Only in a hostile takeover scenario, which involves a proxy and likely triggers a competitive situation. You don't buy 10% on the market if you're Merck except in that scenario and even then, it's way too splashy. Not going to happen.

If they want 10% only, they are going to discuss it with the company and negotiate and likely there will be some other factors that will lead to proper valuation despite what is going on in the market. Most likely those RIGHTS and joint commitments will be about things much broader than the current share price.

Just saying, your scenario is completely unrealistic.

I did not say it was a bust at all. Reread what exactly I said. You need a reading comprehension skills refresher my friend. Very basic stuff.

Thank you Roman. I think it's important to clarify on your post that when you say 30,000 vaccines, you don't mean individual doses but basically a full course of vaccines. They make them by batch, not shot by shot, which was Dendreon's problem. So potentially $250,000 doses for 2 to 3 years, assuming the tumor tissue allows it. I suspect, despite their pre-approval pricing, that they would make the full course all at once because going back after, unless there is new tumor tissue, is very inefficient and costly.

That may be but if DCVax-L had those kinds of sales I think it is a virtual certainty that YOU and every short here would label it a “bust”. Meanwhile the long you replied to said the opposite, that Gilead paid $21B for it.

Shorts play all sides of every argument to always argue, maximally, that longs are “delusional”, that other drugs are better, regardless of the details, and that DCVax-L is a bust, again, regardless of details.

So yeah, if DCVax-L generated those levels of sales, I am pretty certain shorts would be on here day and night saying, “it’s a bust”!!! What else would they or could they do?

You can be wrong and correct at the same time.

Since the numbers after the last 10Q are larger, clearly they are the most up-to-date at this point in time. The 10Q will be definitive as of that date. But the in between updates are the best information possible unless they file something in the interim that is up-to-date as of that day.

Captain’s posts are very helpful and a good deed for other investors.

You don’t need to 8K an application.

This Dunning-Krueger syndrome thing of yours is really a problem. You clearly don’t know what you don’t know and so you’re very confident about the false things you say.

I believe there was a discussion where we went through this with shorts when they left and they were compensated for each milestone. There were indications, but some things, you complete and you can’t wait around for the final outcome, they have staff for that. These conversations are typically is so tedious and really pointless to repeat every 6 months again and again. I expect they will ultimately announce in some form or another when Flaskworks is finalized for actual utilization in the manufacturing process.

I have never claimed that, I have always been consistent in my statements on this matter. I can’t explain why you apparently can’t recall what I have been saying directly to you consistently. Feel free to find some past statement of mine where I said what you suggest. It doesn’t exist.

Nonsense. Advent is a contractor. They may buy it as a courtesy. They do not need to buy advent. There is no IP, nothing critical in advent that is not transferred when they buy NWBo. You do not understand corporate affairs or buyouts if you think that is the case. Contractual rights travel to the buyer. All of advents obligations flow to the acquiring company. Period. Advent has no other significant clients and is under contract to manage Sawston. They get Sawston when they buy NWBO and they get all of Advent’s obligations.

I have dealt with this issue for fortune 100 and smaller companies thousands of times in my career. What I just told you is the basic circumstance. And a buyer would certainly be sure of that before they bought NWBO regardless.

This noise shorts make is about the largest pile if crap you’ll see and is meant to deceive retail. Generally I couch my statements in “I believe”… this is not one of those instances. What I said is basic. Basic, basic basic. Anyone saying otherwise is not experienced in buyouts. There are circumstances where parties agree to terminate outstanding contracts, or parties do not want to have a contract with a following party. Typically that will be where the buyer is of a lower credit value, and usually those parties are banks. Those contracts just like the NWBO contract with Advent are terminable at will, but as I said, a buyer would in fact work those details out with NWBO before a buyout if it was critical. However, a buyer would likely plan to sell Sawston and potentially build their own facility, so that manufacturing might only be required for a transition period anyway.

Advent is a modular provider of services and that is how the CDMO business works. They do a phenomenal job and I do not say this because I want snitching other than prosperity and security going forward, but short nonsense is constantly and wrongly describing situations to deceive retail.

There is no apparent looting going on. This was previously raised with the SEC by shorts and was not found to be the case. Nothing has changed except the provider. Even the contract is based on the same contract. And if shorts thought otherwise they have a remedy even if we all know they’d end up in the same place and be seen for the harassing parties that they in fact are.

I suspect so as well. Guessing.

You sure sound like you’re working this on the short end as a “long”. And you and ExW sound in sync except for your claim you “believe” periodically.

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.