Northwest Biotherapeutics Inc (QB) (NWBO) Quote

Meet Natasha working on Flaskworks Eden biosimilarity. Article from 2023

https://advancedtherapiesapprenticeships.co.uk/latest-news/testimonial/meet-natasha/

What has been the most rewarding or interesting project that you have been involved in and why?

I have worked in the development of a cancer vaccine for a rare brain tumour and have been involved in projects to optimise our current procedures such as experimenting with current automated machines. The idea that I am helping reduce the pressure of working within a cleanroom is rewarding. The potential to optimise the clinical outcome of the drug is even better!

No clinical trials needed.

Each batch is made in a cartridge that is self-contained. Takes something like 8 days but u expect they will be able to multi process during that period because of the self-contained cartridges. That was not part of the original lane equipment, but for a commercial operation, that would be the easiest and fastest way to increase throughput per the space and employee limitations rather than having an entire space, employee and piece of equipment sitting doing largely not very much while the cells do their thing in the cartridge.

As I understand it, whether manual or EDEN it takes just under 8 days to make the vaccine. Some believe the EDEN may be optimized to do it quicker, but I'm not aware if that's the case, and if it is, how much quicker. Best to figure roughly 50 batches a year from each tiny cleanroom or each EDEN.

I certainly don't know, but if excess material exists for patients who're no longer with us, but for whom DCVax-L has been made, I'd hope they could use the excess material and make DCVax-L in the EDEN for comparison purposes. I don't know that's possible, but if it is I would hope a decision on the EDEN could be made rapidly.

Gary

That doesn't seem right to me. I just believe that trials using the EDEN can be permitted before full approval come, at that could be just a couple months from now.

The process for getting the EDEN units approved was laid out at the AGM. I can't see the MHRA approving the use of a biologic that comes from a process that has not been certified. The EDEN process has to show that it produces a product that matches the approved product with GMP criteria being met. Since it is a new physical process getting the GMP part is going to take some time. The thing that stuck out to me from the AGM comments was that the process has to show that no particles are leaking out of the EDEN machine that could endanger the operators.

It looks like approval for the biologic will come any day. The EDEN certification process is going to take months after they get the hardware in and installed. By the way, do you know how long it takes to create a batch from receipt of the tissues? I don't recall seeing that number.

Gary- do you realize what you just said. getting approval and it will be conditioned on further trials. We spent more than 15 years and mucho money to come to this goal post. The further trials is a slap on LP, LL and shareholders. Common man

You’re a fool. You cannot fool 73 coauthors.

I agree with you there completely Kab. I just believe that trials using the EDEN can be permitted before full approval come, at that could be just a couple months from now.

I have no idea if LP is looking to surprise us all by having the Brits examine the EDEN at the same time they're evaluating everything else. Not saying this is the case, just looking at possibilities and why a 150 plus perhaps 60 day process has taken over 250 days, and counting. I feel over 99% certain we'll get an approval, it's possible that it will be conditioned on further trials, but hopefully they'll permit the use of other therapeutics, like Poly-ICLC, which better than triples the 5 year survival seen in the Phase 3 without it.

Gary

Thanks Gary. I wasn't focused on use of Eden in any trials, though that would obviously be desirable. What I was objecting to was the random claim by negative Nelly investor082, that it will be years before Eden can be used in commercial production. That was baseless nonsense imo.

I've watched and sometimes been invested in biotech's whose price fell after approval, it could happen here, but not at these prices. If by the time we actually have approval our market cap is in the $2 billion or greater area, then being down post approval is possible, but if approval comes at anywhere near the current price we should rise to something over a billion after approval. I could be substantially more if media coverage is very positive, but if not, over a billions should be a certainty.

Gary

Buy the rumor and sell the news may be a good strategy for traders, especially day traders, but while prices sometimes do come down after the news, the long term investor is often well rewarded for holding and allowing the share price to grow. There is a great deal of good news that can be anticipated over time after initial approval, it comes over many months or a few years, but as approvals grow it leads to revenue growth, ultimately earnings will dictate the price warranted by the stock.

It's my belief that NWBO on the strength of GBM alone with worldwide approvals will be earning billions. No telling how high up is if ultimately the DCVax's are used on multiple solid cancers. With growing revenue for the foreseeable future, I believe NWBO will warrant a P/E of 30, or perhaps even more. If earnings were $2 billion that would give a market cap of $60 billion, if we had 1.5 billion shares outstanding at that time that's a $40 share price. I don't believe it will take that long, but if it took to the end of this decade to get there would anyone object to well over a one hundred banger by then.

Of course anything is possible between now and then, a buyout ends it all, equity partnerships may boost the price farther, faster, but if NWBO's only partnerships are for running trials where the DCVax's are combined with others products the growth can still be phenomenal. Does that mean, don't sell a share, certainly not, sell shares, options, whatever you wish, if you sell out completely I'll wish you well with what you do with the funds. Personally I'm looking forward to when NWBO's at or near double digits and options are available, I'll be looking to make pocket change perhaps approaching six figures annually from selling out of the money calls on a small percentage of my shares. I don't mind getting interest from some of the shares being borrowed, I really don't believe they're at risk and as the share price rises, this too could bring in tens of thousands or more annually.

Gary

Just more stream-of-consciousness psychobabble verbigerations. Keep that garbage inside your head.

You are exposing yourself

Ewwwwwwww.

Can’t say I’m surprised, though. Creep.

You cannot channel everyone. You are just a minion who bets against the company.
Wait and see what will happen when the approval is granted.

Why do I need to understand pharma? I trust LP knows pharma better than anyone else on this planet.

BTW, do you understand my posts about why DCVax-L is revolutionary?

Kab, I believe that new trials could be initiated utilizing the EDEN after some initial testing that was successful, but before full approval was granted for commercial production. It's hard to know if the company has advanced it to this point already, but I believe by late this year or early next they'll be able to initiate new trials utilizing the EDEN.

Gary

Best way is to take this deal…

Whistleblower awards can range from 10 to 30 percent of the money collected when the monetary sanctions exceed $1 million. As set forth in the Dodd-Frank Act, the SEC protects the confidentiality of whistleblowers and does not disclose any information that could reveal a whistleblower's identity.

Whistleblower awards can range from 10 to 30 percent of the money collected when the monetary sanctions exceed $1 million. As set forth in the Dodd-Frank Act, the SEC protects the confidentiality of whistleblowers and does not disclose any information that could reveal a whistleblower's identity.

There is a bigger picture here than the Statistical Significance achieved by DCVax-L. The results from the Combination Therapy, excellent Safety Profile, Immune response and the fact that rGBM is a deadly disease.
Even if no Statistical Significance was achieved, approval might be granted on the basis of the disease and the measured immune response. If you’re thinking they will make NWBO run another trial, think again. It’s taken 30 years to get a positive result.

Maybe you don’t understand pharma ;)

Everyone realizes that’s why SP is where it is . At the end of the day all is that matters from investment standpoint . Science fair part can carry on .

Could've had a nice article like this but they passed on it AGAIN.

https://www.oncologynewscentral.com/article/after-astounding-survival-results-in-sclc-updated-data-raise-question


Btw,

>>“Cisplatin is our long-held standard for limited-stage small-cell lung cancer. We would often reserve carboplatin for patients who were not robust enough for cisplatin, patients who had comorbidities, impaired renal function, so one might suspect that, in the cisplatin arm, we might see younger patients with better performance status, and that’s exactly what we do see,” he said.

Go easy on yourself. You don’t take up that much space.

You really need to do your homework before betting against the revolutionary science. You mean those researchers from BPs cannot realize how revolutionary is the technology that NWBO owns. Are you trying to be funny?

Is that why they're not there because she's afraid of bumping into Adam?

Another saviour. I thank you.

Time for ship to turn around

If nonmanagement does a deal with conditions, then they are WAY dumber than we all knew, and still best to sell any decent pop than suffer those fools any longer. They are going to shed SH by the thousands if they fuck this up again.

Agreed. Although, we would be lucky if we get any meaningful pop now, particularly if UK approval has any conditions attached to it like running another trial?

Bunch of liars.

There is a good reason I put flipless on ignore. But your making the board suffer your replies when talking to a tree would produce better results. Give it a rest and ignore that clown.

Thanks Adam.

I was saying that you can’t say there is no chance a BP is interested or not simply because NWBO does not have a new combo deal right now.

There could be a perfectly good reason. Like we are days/weeks away from an approval decision, and perhaps a BP would not want to get out their wallet yet.

It’s ridiculous for you to say there is no BP interest simply because there is no combo deal now. It is concrete thinking. They could be interested, they might not be based on your one criteria.

Sell the pop is the best way out from under this inept mute nonmanagement group of clueless clowns. What a mess they have made out of real science. Greedy bastards.

New STAT News article out!

"After 10 years of game-changing immunotherapies, a cancer conference celebrates — and sees more work to do"

>>The annual ESMO meeting featured gratitude and also debate"

LP and LG should be sued for lying to shareholders again and again!

Manual production has been approved. So there is no uncertainty there. So again what payout were you referring to there?

I didn't ask for any specifics around payout terms except I wanted to rule out NWBO having to pay for the vaccine and participant recruitment cost. Can we accommodate that?

How about this deal:

There will be a combo trial deal with another company before March 2025 and this will be at no cost to NWBO.

You say yes. I say no.

If no BP is interested, why are you here 24/7 posting diversionary comments? Bad stock, Bad Management, etc, etc, etc. Only one reason. To try and create a smoke screen so the market makers can drive the price down. If you’re not on the site, new investors will buy at these prices which are worth more than the current SP.
You are an integral part of the manipulation effort and deserve to be prosecuted as such.

How could I possibly know what payout terms would be? I did not contradict myself at all.

Answer this. Would you make a combo deal with a company just before it was known whether or not their product was approved. I’d say, no, you would not.

This was my first question in the thread.

Don’t be dense. If you were the CEO of another company, would you pay for a combo deal if DCVax-l was not approved? No. So your point is moot.

Yet you say, effectively, there can’t be any interest by big pharma, because NWBO has not entered any combo deals yet.

That’s just poor logic. It’s dumb rhetoric. Does it mean there is interest? No. Does it mean there isn’t interest? No.

Of course.

Flip just confirmed that he does not expect any cash payout (forget about significant cash) and a big pharma to PR combo trial deal. Rather he expects a small company like Oncovir to be involved! ;)

It’s logical that there will be a major dilution to fund this trial. What I am now thinking is will there be any conditions attached to UK approval like running another confirmatory trial, which is why LP would want to start a larger combo study with Oncovir in 2025. And this is why share price has been tanking with no real buying interest because major dilution is expected? And another reason for not going on a hiring spree and filing reimbursement evidence.

Watch out for sell the news at UK approval! I thought we would at least get a nice spike at UK approval of somewhere in between 100-200%, but that looks very doubtful if UK approval has some conditions attached to it. We might even sell off who knows!

You have contradicted yourself. Why did you say this then:

“No, if you were a CEO of another company, would you not want to see the commercial version installed and producing a few acceptable DCVax-l batches (albeit not verified by MAA for commercial use yet) first before you began to pay for a combo trial? At this point, I would, before I signed”

What payout are you referring to here and why wait for Flaskworks if you are a small company that is not intending to pay NWBO anyway. Just get on with a combo clinical trial right away. Manual version is ready.

There are enough facts for me to currently bet (against you) my posting privileges that I believe a combo deal involving NWBO (or whatever entity it is at that point) will be announced by March. There are not enough facts for me to bet my posting privileges what level the drug/biotech company will be, what financial tradeoff will be, or when it will start.

You are scared to take my bet, and want to add contingencies.

No bet.

Ahh, you don’t like BP and you don’t like payout to NWBO. Thanks for proving me right once again. No big pharma is interested in supporting NWBO.

So what you are implying is this:

There will be a combo trial deal with another company before end of March but there will not be any cash payout to NWBO.

Where will the funding come from? Major dilution ahead?

Here is the path to biologic equivalence according to LP at the ASM [highlighting below is mine]. What part of no clinical trial is required don't you understand? Please explain where you get your claim that a clinical trial will be required to certify Eden for commercial production.

So now that the adaptation for clinical grade GMP, that design work has been done. The remaining steps are; complete the the streamlining, or condensing some of the portions of it, get the units ordered, have the units delivered, and then Advent will need to conduct a large amount of, what are referred to as, engineering runs. They're practice runs. You have to run, do practice runs with the Flaskworks machine in the Sawston facility, collect all the data, compare the data with the data from the DCVax products produced by the existing manual process, because they have to show, they have to demonstrate to the regulator, not only that the Flaskworks machine operates properly, doesn't shed particles into the clean room air, things like that.

We have to show that it produces a product that's the same, or as close to the same, as a biologic product can be. So they'll be in addition, after they do all of these engineering runs, and they collect all the data, they'll do comparability studies, equivalency studies, and collect the data from that. And then all of that will be submitted to the regulator, and the regulator will give approval. And this will all be going on, these are all things, all going on in parallel. Right? So this will be going on over the coming months, at the same time that the MAA process is going on, and the same time that the inspections are going on, and so forth. So it's not stretching out, you know, to infinity. It's parallel. What else on this? I think that's enough.

No. You are still adding contingencies, and you were not right in the first place.

This is the bet I will take, I believe there will be a combo deal announced between NWBO and another company before March 2025. (Hopefully much much sooner).

Take it or leave the opposite side of my bet.

Ahh, I see.

You do not want BP in our bet. Then you have proven me right once again. But let’s not get into that.

How about this bet:

There will be a combo trial deal with another company by end of March. And this company will
make cash payout to NWBO for this combo trial.

Is that a deal?

“Post approval” ✅️ Noted



I like the way you’re thinking! It’s almost like your comments are consistent with a somewhat reasonable perception of reality …all of a sudden.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175102539

What LP said about Flaskworks at ASM 1. LP said very clearly in the ASM was that they were not going to wait for Eden to be ready before they start commercial product shipments. 2. There will not be any clinical trial required to move from manual to Eden production.

Another big priority, in this grouping of top priority, is preparations for commercial launch. There, we've been working on this for years, as I've described, but there's still a lot to do. We're very excited about working on this. First off is, we anticipate that we will be beginning commercialization using our existing grade B labs. So we're gonna be pursuing the build out process for the grade C labs as rapidly as we can, but we're not counting on that to get started with commercialization. We're able to get started with our existing B labs. We will, and likewise, we, a part of this preparation for commercialization, will be finishing the process that we described with the FlaskWorks machine.

So now that the adaptation for clinical grade GMP, that design work has been done. The remaining steps are; complete the the streamlining, or condensing some of the portions of it, get the units ordered, have the units delivered, and then Advent will need to conduct a large amount of, what are referred to as, engineering runs. They're practice runs. You have to run, do practice runs with the Flaskworks machine in the Sawston facility, collect all the data, compare the data with the data from the DCVax products produced by the existing manual process, because they have to show, they have to demonstrate to the regulator, not only that the Flaskworks machine operates properly, doesn't shed particles into the clean room air, things like that.

We have to show that it produces a product that's the same, or as close to the same, as a biologic product can be. So they'll be in addition, after they do all of these engineering runs, and they collect all the data, they'll do comparability studies, equivalency studies, and collect the data from that. And then all of that will be submitted to the regulator, and the regulator will give approval. And this will all be going on, these are all things, all going on in parallel. Right? So this will be going on over the coming months, at the same time that the MAA process is going on, and the same time that the inspections are going on, and so forth. So it's not stretching out, you know, to infinity. It's parallel. What else on this? I think that's enough.

Nope, you added contingencies. BP show interest all the time by working through third parties. I once bought shares in a company making an antibiotic, it was bought for cheap by a small bio, I left with little profit, then that second small bio was bought for a much higher percentage and was gulped down by a large BP (Pfizer) just a couple months later. Large BP work in mysterious ways, and demonstrate their “interests” methodically.

Well , then if approval comes before end of the year and there is no announcement of some large upfront cash in form of partnership/licensing/JV etc , then don’t be surprised at a very Luke warm response esp on OTC in my opinion . But one can always blame nefarious forces .

For sure, the more merrier. Ask LP not to disappoint and come up with excuses post approval.

Thanks! You’ve got me thinking here … the possibilities are intriguing. Merck and Bristol Meyers are always top of mind, but you’ve really made me consider the others who could come into play too!

…Traded companies with MC over 10B .. 🤔



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