Northwest Biotherapeutics Inc (QB) (NWBO) News

Fortunately, LP & LL know more than you. We do know that FlaskWorks was not ready for production and I believe they want to Flaskworks certified when they start production in the US. I also believe they needed to pick one financial battle at a time. These are 2 guesses on my part. Like I said, management knows more than you. I trust LP and her goal is to bring DCVax-L to the market.

For posters like Manibioteg, the real question he should ask himself is,"What kind of an investment banking group would loan a pre-revenue biotech company on the OTC at .25 cents per share, $5,000,000 for 13 months for a 7% placement fee with no payments due AND commit for a $50,000,000 "standby" line after the $5 million repay for 24months and agree to accept NWBO common shares at a slight discount to the then current price without believing that the company represents a solid, going concern value for the next several years"??????

AND the answer should be, an investment banker that is confident that the company will receive MHRA regulatory approval and many more RA's from multiple other countries AND have the MTD in the company's current lawsuit denied opening the door for Discovery with an eventual settlement or a major Trial Victory. Yorkville is that banker, who, by the way, underwrote a $38,000,000 offering for DJT's social media company that was also attacked by Ken Griffin's Citadel taking theTruth Social from the $50's to $12 . That's a $93,000,000 bet on 2 companies attacked by Citadel.

NWBO is across the finish line and Citadel and Virtu are looking very puny!!!

Cheers,

BB

Yes, the same guy who knows a little about the numbers game but nothing about the science, the guy who told us two years ago he was leaving the board, only to suddenly reappear when the company is on the verge of regulatory success. And all because he cares about us stupid retail shareholders? He's just drawing a paycheck.

Flaskworks won’t be approved commercially until second half of 2026 at the earliest. Take that to the bank!

Well as some have been saying that if they already have a deal signed contingent upon approval , it shouldn't make a difference in my opinion . Unless you are saying there is no deal finalized as some have been touting .


Good question!

Here are my thoughts....As you stated...IMO, a deal has been signed contingent upon approval. I also believe, upon approval, Merck has other motives beyond the "deal"....As in buyout, which may not be in the best interest of shareholders long-term AND not to LP's current plans....She is thinking Franchise while Merck may be thinking they want the entire company...So, with this line of thinking (on my part), there is nothing for Merck (or any other BP) to be a "nice guy" and loan money to LP&co. BP's have a lot of cash, however they are not in the loan business. Bottomline...Perhaps, Merck (and other BP's) have decided to wait and see. Stay under the radar until it is time to show their hand(s).

For sure, there could be no deal. However, I am long and hopeful. Not only for the money but for the promise of a cure. Having family members die of cancer and an uncle to GBM, I have an interest in success that goes beyond monetary reasons as I'm sure many here also.

In any event, we should be very (extremely) close to a decision.

Best wishes to you and a Happy New Year to all!!

exwannabe,

If there had been a Specials like program in the US since 2012 when the safety profile had been well established, this facilitated access could have possibly caused Cognate to remain the sole initial CDMO for commercial production. Best wishes.

DCVax-L label approval in the UK will include, at a minimum, all newly diagnosed Glioblastoma patients (nGBM) and recurrent Glioblastoma patients (rGBM).

It’s possible that the approved DCVax-L label could be expanded to include all malignant gliomas patients (all malignant Grade III astrocytomas and Grade IV Glioblastomas).

That would be a short analysis.
DCVax-L achieved statistical significance in both rGBM and nGBM. This is the FIRST trial in 30 years to move the needle on rGBM. So let me get this right why would you only approve a sub type?
The real question you should be asking yourself is what other types of solid tumors will they use this treatment on off label? Many people cannot tolerate chemotherapy.

Should have read just less than a 2:1 enrollment rate remaining. Best wishes.

space~farm,

You know that “should” is the operative word. With cost reduction being an obviously big factor for a health care system more constrained by finances, it seems the smaller footprint move was also necessary to reach some sort of realistic business opportunity for NWBO. I was disappointed that the first GMP iteration of Flaskworks evidently was not going to get NWBO where they needed or wanted to be with margins or volume and so another delay because of the need for a smaller footprint. Best wishes.

I agree with your assessment which is why I’m a little concerned that approval will only be for a sub type

I don't expect that. There was a modest improvement with DCVax-L for unmethylated patients, and since there is no good alternative and the safety profile is benign I don't think that makes sense. I also believe the regulators will be factoring in the possibility of significantly better survival outcomes for all patients with future combination options and would not want subgroups excluded.

I agree with your assessment which is why I’m a little concerned that approval will only be for a sub type. At best the PPS will nominally appreciate under this scenario.

Results are marginal once adjusted for nwbo advantages over competitors in full resection, KPS score, patient health, etc.

"Marginal" is of course subjective, and while I disagree that the mOS advantage, after the adjustments built into the SAP, was marginal, for argument sake let's say it is. Is there more to the trial results? Here's LL in an interview in March 2023 with Kate Nevell from Neurology Journal:

"…what I think maybe even more interesting is the long tail end of the survival curve and some of the subgroup analysis results that came out of the trial. For instance the median survival of the MGMT methylated patients was over 30 months, with almost 20 percent five-year survival. It was interesting in that the majority of these patients surviving over five years are surviving without recurrence, which in the field of glioblastoma is actually quite unusual."

Are those results, which have been supported by other data, "marginal?" What about this from the JAMA article:

OS in Patients With rGBM
The 64 patients with rGBM who received DCVax-L after recurrence had mOS of 13.2 (95% CI, 9.7-16.8) months from relapse vs 7.8 (95% CI, 7.2-8.2) months in the ECP (HR, 0.58; 0.00-0.76; P?<?.001) (Figure 3). These data indicate a 42% relative reduction in risk of death at any point in time for patients with rGBM treated with DCVax-L at first recurrence, and this survival benefit continued over time (Table 2): 20.7% of the patients receiving DCVax-L vs 9.6% of the patients in the ECP were alive at 24 months after recurrence, and 11.1% vs 5.1% were alive at 30 months after recurrence.

P<.001 in rGBM, where the SOC is palliative care? KPS score and patient health imbalances explain that? Is that "marginal"?

That's why there is no word from UK more than a year after submission.
No, that's not why, which will be clear in the coming weeks.

Flaskworks was acquired in 2020. The work should have already been done.

exwannabe,

Your thesis collapses when you say the regulator will not allow new patient enrollment because at the time of the screening halt around June 2015, 299 or 300 were enrolled and enrollment continued from June until November but only in the treatment arm. SOC/placebo ended up shorted by 17 which constituted just more than a 2:1 treatment to SOC enrollment rate remaining to be done after the halt. Almost 100% of patients at that time were being enrolled from Germany. This means the Germans were keeping patients out of the trial likely for ethical reasons assuming they knew that SOC/placebo was a lesser treatment. By law they do not allow patients to be given a lesser treatment. Fraunhofer made this pretty clear when they stated in their 2015 annual report that patients were only enrolled to the point statistically necessary. The findings in the peer reviewed article in JAMA Oncology basically backed the rational for the halt being due to benefit with published results that showed the best advantage went to earliest treated patients even though rGBM patients had benefit as well. Germany also was the only jurisdiction that had early eventing low absolute lymphocyte count patients enrolling meaning that identifying benefit from treatment would be recognized earlier in this group of patients. Go phish!; ). Best wishes.

Investor082,

So how would setting up expensive to maintain and soon to be unneeded clean rooms be a good investment strategy for NWBO or a partner?; ). Maybe the other jurisdictions are for Flaskworks launch and a truly viable business model that includes reimbursement at a rate sufficient and necessary for a healthy bottom line with rapid, steady growth possible that addresses expected demand and reduces limitations on patient access sometimes created by health care agencies with higher cost treatments. The timing for an application to these jurisdictions sure looks like when big pharma would want to be in on the action once Flaskworks is approved or is at the stage of being just a formality. Certainly management will take the heat but they also extended an olive branch in 2018 by asking for help with manufacturing development that was never taken. Linda will not give away the farm to only possibly get done a little sooner and big pharma didn’t want to get involved for their own reasons so no one can truthfully say they didn’t try to advance more quickly. Best wishes.

Same, I still think there is a decent chance for an exit (relatively) unscathed, aside from the opportunity cost of having to sit on an investment for so long.

My main concern is a conditional subtype approval and issues with reimbursement (CAR-T took a while and is still a tiny market, granted it’s for a different indication)

So....you watched the litigation and difficulty as it unfolded after communication issues...and you stayed...

Yeah, it is what it is.

MHRA, please get me out this asylum.

Agree 
Thing is I invested when it was still on NASDAQ and not silent long time ago . 
But it is what it is 

Thank you for the graphic.

Ha. No offense was intended.

My point was that all the complaints on this board - EVERY ONE are issues identifiable up front via pre-purchase due diligence.

Of course, everyone now just cannot, I mean CANNOT, understand why the company is silent.

Sad.

If you follow ASCO session reports, PFS is regularly used as a primary endpoint. Even Dr. Liau has chosen PFS as the primary efficacy endpoint for her SPORE/UCLA trial -- she must surely have confidence in the measurement methodology. And again PFS is very common efficacy endpoint, but yet seems only NWBO has a problem with it in their trial. Sorry, they chose PFS and FDA agreed with it from the beginning of time -- even Dr. Liau agreed. Only when they did the interim analysis and it was obvious they were going to blow the trial primary endpoint they suddenly made dubious claims PFS can't be used even when hundreds of oncology trials use it.

It is certainly NOT a manufactured problem, it is a problem for the fanboys who bought the NWBO denial because they likely have too much cash tied up with this stock. Have you even noticed that MHRA is now months past due for a decision which means NWBO has been trying to deal with the trial issues that MHRA has raised. And NWBO has not made ANY public mention of the status of the review -- deny, deny, deny. Hoping that they can get some other data from UCLA possibly. MHRA claims 150 day review and it's been months since that end date.

Management must take the biggest blame for not applying in the EU and one of Canada/USA at the very least. Over 4 years from data lock. No one takes this long. Not even a company of half a dozen people. Diluting close to 500M shares and true ups along the way!

I hope it is tomorrow…..lol.
Thanks. And good luck

😂😂.

Don't need investment advice from you .
I get it accountability is not looked upon nicely on this board . But that's your prerogative . 

Those attacking Northwest Biotherapeutics have blood on their hands.
If -L actually works then supporters of management have blood on their hands for not only delaying the start of a proper trial for 7 years or so, but diverting funds intended for it to L's CDMO.

Steady is dead on, co silence is clearly deliberate. The only solution is to find another horse if it's too distasteful or if you think it creates too many negative 2nd order effects.

But how do you really feel about the company?

Do you have anything to support the "futility halt recommendation". Seems like the trial continued.
To correct the wording, the DSMB recommended a futility finding. Per US law, the sponsor, NWBO, decides if the trial can continue. But the FDA will decide if that precludes enrollment of new patients and would issue a hold if they decide to.. As far as evidence, what we know is:

. An efficacy IA was conducted in 2015 (per the JAMA paper). NWBO disclosed it would happen, but never said a word about it later.

. The data presented at NYAS was clear that futility would be seen. It does not matter if the reason was psPD or not.

. The FDA in such a case would follow the law and allow the trial to continue if no safety issues were present. But they would not allow new enrollments as it would be unethical to have patients sign a consent (which in the trial happened at initial screening). This action by the FDA can be seen in the CVM case that was almost identical.

. Despite this being the core thesis of shorts, NWBO has never disclosed the reason despite there being no reason not to do so.

. LP is on record saying after the hold was issued that they wanted to restart enrollment "soon". If the reason was for any good news, NWBO would not say this.

Now, some dot connecting:

. NWBO went dark on the IA because even though is is legal not to disclose such, if you disclose the IA happened it can be "lying by omission" to not disclose the negative story. See the case Anders posted repeatedly where the exact issue was decided in Court.

. LP wanted the trial enrollment to resume because they were trying to change the endpoint to OS. The FDA disallowed this because the trial had already performed an IA, thus the endpoint change would still no be part of a "well run trial".

. As a factual note, NWBO implied in PRs in late 2016 that the trial was ending with planned 211(?) PFS events. Then later when that passed that it would end with 2 more OS events. Then it would end whenever. As a theory, I take it as obvious that with the trial already formally busted they were having the DSMB (or some such) perform analysis to see what was working. This would allow them to properly say the trial was still blinded despite knowing what was going on. If you doubt the legality, you can find many PRs by respected BPs that announce results while also saying the trial is ongoing and still blinded.

You can believe what you want. LP could always deny any of this, and does not.

Exactly .... by same logic , not taking check book from BP and getting every thing done years sooner . So assigning blame is a two way game 

Well that's ONE of the big reasons for the current SP
And once company takes money from public/shareholders it has duty to provide shareholder value which of course is a foreign concept on this board 

The notoriously irrelevant clinical trial data!

With that logic you can also blame the pumpers for being so complicit and satisfied with managements glacial pace.

Longer than some. Shorter than others. Coming up on the July-November 296 clock-on day average.








*assuming clock start on 1/24/24 validation and one 60-day clock off period = 281 clock-on days since validation.

The company has legal requirements about communications with stockholders. Filings with the SEC and material events.

Beyond that, it is the company's discretion as to what information to share.

You may not like the amount of information the company chooses to communicate but as long as it complies with the legal requirements not a lot you can do except bitch about it. Well..... you could sell your shares and walk away.

So, new lows for this stinking POS. Longs wondering why nothing from mute inept nonmanagement. No MTD. No approval. Linda Grifter is raking in the $$ while nwbo burns, there has to be lawsuits forthcoming against this POS. So sorry I ever told anyone about this crap. Never ever seen a more worthless clown crew runnig a company. Stinking POS.

exwannabe,

Roswell Parks started over 2 years ago and IL-7 integration started before that after initial results came back from Phase 1. Development time was unknown for IL-7 and Covid hit which created changes in execution focus that stretched into Roswell Parks developments. Take all this and add in the specific type of BCG shortage that developed that NWBO was forced to consider with development plans for Direct and you can take your pick of reasons why things got delayed the way they did. Point being that now they are in a much better place with upgrades and workarounds; ). Best wishes.

Maybe go take that argument up with the scientific community.... or continue to live in that delusional world where you think you know anything about science.... let alone how to intepret statistical outcomes. That is best left to those that signed off on the JAMA article...you know, the 'other guys" that get paid to do the research, not the guy working over the Christmas holiday to spread fud on a message board.

We are now 340 days since Application validation of January 24, 2024.....

I am bullish too. But you know NWBO management never released multiple good news in a row during the past. Management is not aggressive at all. So don't expect it will happen this time. Approval is approval, buyout or partnership news might not come until few months later..

First there is no such thing as FOIA request to a company. FOIA is directed at governmental agencies.

Do you have anything to support the "futility halt recommendation". Seems like the trial continued.

exwannabe,

I think you misread my post to some extent. The lack of disclosure only concerned data up to the point of data lock. After that point it appears the lack of disclosure was more about business concerns as some folks were likely unable to trade on non public information which has made it difficult to bankrupt or buy out NWBO on the cheap and if it has anything to do with something positive NWBO might easily see too many shares go into the wrong hands for them to maintain control to maximize investor return based on Linda’s plan for leverage in negotiations. It’s definitely a tricky dance to get to the point that others will need to pay up for their connection to NWBO at a reasonable valuation for all that has been done and the potential for future reward; ). Best wishes.

Those attacking Northwest Biotherapeutics have blood on their hands.

https://open.substack.com/pub/bamboolounge/p/nwbo-shorts-and-fudsters-have-blood

Gee. Let's fight over something that happened 10 years ago, as if it makes a lick of difference to the MAA outcome.

MAA decision is all the matters at this point in time.
The rest is just entertainment.

Curious why not wait until UK approval to sell? Its pretty much a done deal and we should see at least a 50% spike, if not close to 100%, within a month or so.

Jackxkr your words echo the truth. Means nothing to them, as long as the information can't be verified.

Well as some have been saying that if they already have a deal signed contingent upon approval , it shouldn't make a difference in my opinion . Unless you are saying there is no deal finalized as some have been touting . 

longs know what and why they are holding

Something that's lost them 95%?

Ah yes, Merck that's apparently not interested helping out NWBO with a loan?

Why is that?


The answer is very simple if you think about it......

By doing so, Merck (without an official agreement),would be "tipping its hand" and thus increase the amount of a potential deal.

If Merck "loaned" LP say 20M, then word is out on the street that Merck is dealing with NWBO and thus the share price of NWBO will likely rise...permanently AND most likely increase the value of a deal....Considering Merck would rather wait until approval so money isn't wasted....Pay more upon approval vs. "gambling" now with the approval status unknown...We are so close to a decision that it really doesn't make sense for either party to strike a deal pre-decision. We just need prroval for everything to fall into place.

Soon!!