Northwest Biotherapeutics Inc (QB) (NWBO) ニュース

She has had all the time in the world for the last 10 years yet she messed up TLD release. Nothing will change at the UK approval announcement. The excuses and victim mindset will continue. And so will the endless dilution.

Only thing that changes the narrative is non dilutive funding from big pharma. Nothing else matters at this stage. Fluff PRs like Oncovir partnership will have no impact on the share price, just like Roswell Park announcement. If anything, the markets will sell the news.

Don't like the sound of this especially after I have bought more this week.

Not in this case – see https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175897450

But it does happen all the time that medicines are approved out of order.

It first appeared in the minutes for the February 22 2024 meeting:

a medicine used in combination with platinum-based chemotherapy indicated for the first-line treatment of adults with metastatic non-small-cell lung cancer caused by changes in a gene called ‘EGFR’ (Epidermal Growth Factor receptor).

In this case, there were 7 months in between the first meeting and the second, rather than the 6 which is more common.

Perhaps the poster didn't read the post correctly that I was responding to?

"Every dog(S) has his day(S)!!" 🥁⚖️🧹🔐

JunkSavvy
@JunkSavvy
BREAKING UPDATE🚨🚨
META MATERIALS BANKRUPTCY TRUSTEE ISSUES NOTICES OF ISSUANCE OF SUBPOENAS TO PRODUCE DOCUMENTS and... EX PARTE MOTIONS FOR ORDER REQUIRING CUSTODIANS OF RECORDS TO APPEAR FOR EXAMINATION for...

CITADEL SECURITIES
ANSON FUNDS
NASDAQ
DTCC
FINRA
SCHWAB
TD AMERITRADE
TRADESTATION
VIRTU

DOCUMENTS: courtlistener.com/docket/6902957…
https://x.com/JunkSavvy/status/1897745317245993296?t=bBr-KponBlWj11S676OoWQ&s=19

NOTE: SUMMARY OF THE COMMISSION ON HUMAN MEDICINES MEETING HELD ON
THURSDAY 21ST AND FRIDAY 22ND NOVEMBER 2024 published today.
https://app.box.com/s/jv487awvqzzsrdql0o34h9gg350ceyd4/file/1795506843637

But the September minutes are not yet published. Perhaps they skipped the month?

The Market Maker can control the settlement price with Zeros on the left side of the decimal point.

And it was approved by
FDA in August https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lazertinib-amivantamab-vmjw-non-small-lung-cancer and
EMA in November https://www.ema.europa.eu/en/medicines/human/EPAR/lazcluze

Agree 1000%!!!!!!!!!!!!

Cheers,

BB

Right, these "time lines" are noise

So it's CHM meeting was after DCVax, but they got approval first?

Nice find Starric!

I looked into the CombiG-Vax with CoPilot.
It’s years away with phase 2 results.

CombiG-Vax is a dendritic cell vaccine currently being studied for its potential to treat glioblastoma (GBM). The vaccine is part of a phase II clinical trial conducted by the IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori” in Meldola, Italy. The trial aims to evaluate the progression-free survival (PFS) and safety of the vaccine when integrated with standard therapy in resected GBM patients.

The study involves administering the vaccine after the completion of radiotherapy and chemotherapy, with weekly administrations for four weeks, followed by alternating monthly administrations with temozolomide (TMZ) cycles. The primary endpoints of the trial are PFS at three months and safety, while secondary objectives include evaluating the immune response both in vitro and in vivo.

The initial results from the first step of the study have shown promising outcomes, with the enrollment, treatment, and follow-up of nine evaluable patients.

If you have any more questions or need further details, feel free to ask!

As for the SP, IMHO, I can see LP having a plan A and a plan B, with either executable in short order. We can pretty much assume that the wolfpack is prepared to resort to their standard playbook. Does she bait the Wolfpack with less meat on the bone, to see what the pack is willing to throw at the announcement, pre-market, at opening, etc.? Let's consider plan A consisting of positive achievement announcements in succession, spaced and timed, with the trading action in mind. Let's suppose for some reason that the MM's have a way, you know, whatever their illicit methods are to prevent the SP from running up.
LP would have plan B, or the mother of all bazooka's to deploy. It could be any number of options really right? She could announce:
- Direct trial official start date
- Signed Partnership(s)
- Eden Rollout
- C rooms ready
- Merger announcement i.e. with Revimmune and or with an additional synergistic entity. LP is a monster in this area. I wouldn't want to speculate.
- A new CUSP registration number under submission.
- Granular plans of a move to a different exchange, and what the specific steps will look like.
- Miscellaneous insert here___'''
She had a front row seat that infamous May 22 day which will go down in infamy. She's had a lot of time to assemble her strategy. Your most prized bullet(s) is, are, best fired upon a major catalyst, like your "FIRST OFFICIAL APPROVAL." Not before. It's not basketball with nonstop points scored over two hours. She's waited a LIFETIME for this moment. It's beyond stupid shorts spoofing. She has a soup to nuts, "turn-key" business she can embellish any which way her heart desires. Let's go!

With almost 40 attorneys cranking up those billable hours, it must be interesting to control.

Smitty, all I'm saying it that NWBO has all sort of options. There is no set way that they must go forward.

I believe that if a hostile takeover were attempted they'd have to tell shareholders what was offered, and their intention to reject it. Such a move would be foolish as the share price would almost certainly rise to near the offer price and necessitate a higher price if the offeror were serious. I don't believe it will happen, companies don't like spurring on a bidding war, so they'll negotiate until something acceptable is found, but that won't happen at anything near todays stock prices.

Gary

no, "without prejudice" means it temporarily dismissed. It can be bought up again at a further time

seems you have a answer for everything. Lots of time on your hands. But I am willing to bet nothing you type will come true. NWBO is the opposite of what rational investors think. I have been wrong myself, but was smart enough to stop postings nonsense after all the delays. You might be wise to do the same.

Your clueless skibigtoe.

I'm fine with or without a BP partner, I just hope that if Toucan takes a far great position to fund the company it's at a substantially higher share price.

Once UK approval is in, EDEN approval is in, new trials have begun, and filings for approvals with other regulators are in place I think our share price will be approaching double digits, if not already in double digits. If Toucan is bringing in funds at that point, I'm fine with it.

I'm not certain that BP's won't be bringing in substantial funds to run trials with their products combined with the DCVax's. If that's the case, NWBO will be bringing in substantial money and giving up no equity for it.

I believe that LP has done an amazing job to reach this point and she has the knowledge and experience to keep this going till we're among the biggest of the biotechs.

I don't believe that LP needs billions, or even hundreds of millions to grow the company. I believe that vaccine production, distribution, and perhaps even sales will be done by CDMO's and others who will profit nicely from what they do, but may pay the company for the privilege of doing so.

I don't believe the company will sell the EDEN to anyone. Others may pay to lease them, or the company may provide them, the point is, such agreements can be structured in numerous ways. If another company pays more for the rights, they'll make more for each batch of the vaccine they deliver. It will be up to all of the companies working with NWBO to negotiate the terms of their specific agreements. I really can't say if this will be just one or two companies, or if LP will have numerous companies located all over the world licensed to utilize the EDEN system to make the vaccines for certain geographic areas covered by their license.

In the past I've voiced the opinion that Advent and CRL could handle this entire effort if they wished, but that's certainly not the only choice. No one knows, CRL might have no position at all, we'll only know when something official is announced.

Gary

Don't be so sure --- LP has surprised up multiple times

I believe the news items released are going to be awesome.

NEWS ITEMS

Yes Sir!!! These dudes are SIL !!!!

Cheers,

BB

BB - Yep! The denial is HUGE!

They can control the SP, but they can't control the settlement price AND that's going up everyday!!!

Cheers,

BB

IMO there are no BP partners waiting in the shadows. LP intends on moving forward with an arsenal of Toucan biotech investments.

If by the time of the Annual Meeting we have the UK approval and perhap a great deal of additional news resulting in a share price well over $1 I believe that shareholder will have no qualms about increasing the authorized shares, the only question is, how high.

Frankly nearly all the longs I know would eventually welcome one, or more BP's taking an equity position in NWBO as part of a partnership with them. Most believe that LP would take them in at a market cap of $20 billion, or more.

That market cap would represent say about a $10+ share price if shares outstanding are approaching 2 billion, and that many shares may be necessary.

Why? Because if a BP is taking say a 20% ownership in NWBO, they're either buying all those shares from the company, or the company is providing say 50% of the shares to generate a lot of equity being available, and shareholders are tindering the remaining shares. Either way, substantial shares are required to permit a partner to have an equity position. If the partner was paying $12 a share, and say 1.5 billion shares were outstanding at the time, over 300 million shares would be required to give them a 20% interest.

If the company issued all new shares to meet the demands, they'd receive hundreds of millions to operate with, but of course the O/S would grow by over 300 million shares.

Of course we don't necessarily have to commit to the shares needed for a BP partnership now, but at some point sufficient shares will be needed to do it.

I have no qualms about giving management the shares needed for a future partnership once we're looking at a share price in dollars, or not, but if we are to take in a BP partner, and bring in a great deal of working funds by doing so, a lot of shares will be needed to do so.

Gary

Also interesting the everyone here ignored the article, as usual.

Got to love those 6 digit trades.

This new medicine had an extremely long duration from 1st CHM meeting to approval – 378 days, which is the second longest in my dataset (just beating out mRESVIA (371), which was approved last week, and just behind Sugemalimab (398), the longest in the set).

tunnelvisionofplenty,
I think it's more like 224 days between the first CHMP meeting and the approval today.

SUMMARY OF THE COMMISSION ON HUMAN MEDICINES MEETING HELD ON
THURSDAY 25TH JULY and FRIDAY 26TH JULY 2024
The Commission considered and advised on medicines used with another cancer medicine to
treat adults with lung cancer called non-small cell lung cancer when the cancer has spread to
other parts of the body and has gone through certain gene changes.
https://app.box.com/s/jv487awvqzzsrdql0o34h9gg350ceyd4/file/1722468014372

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 6 March 2025, approved lazertinib (brand name Lazcluze) for adults with non-small cell lung cancer that has spread to other parts of the body and has undergone specific changes in a gene called epidermal growth factor receptor (EGFR). It is to be used in combination with an approved cancer medicine called amivantamab.
https://www.gov.uk/government/news/lazertinib-approved-for-use-in-combination-with-amivantamab-for-the-treatment-of-adults-with-non-small-cell-lung-cancer?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=38e7cbd1-9503-4735-8318-3d76dbcde455&utm_content=immediately

NOTE: SUMMARY OF THE COMMISSION ON HUMAN MEDICINES MEETING HELD ON
THURSDAY 21ST AND FRIDAY 22ND NOVEMBER 2024 published today.
https://app.box.com/s/jv487awvqzzsrdql0o34h9gg350ceyd4/file/1795506843637

wow we like to make mountains out of mole hills. probably SOP to ask for oral arguments even if you expect the request to be denied. You are acting like we just won the world series when this denial is a foul ball in the 1st inning of a preseason game.

Yeah, but anyway you slice it, Wood's ain't buying what they're selling. I wouldn't want to be in that position.

Besides, it was very poor optics from the Defense. A hail mary move of desperation, dumb enough to believe, that by some remote chance, Judge Woods could be snookered by a graph in need of further clarification. As a layman, it didn't take me more than one pass of Posner's amended filings to understand, that the bar at this stage is naturally much lower, otherwise, Defense could game the court indefinitely. With the idea being, "if you have nothing to hide, and you've done nothing wrong, then with discovery, you have the opportunity to prove it."

Again, I am happy to bet there will be no non dilutive funding this year. And there will be no guidance/details of non dilutive milestone funding.

Meanwhile, endless dilution will continue in 2025 and 2026. In fact, my bet is they will beg shareholders to raise the authorized share count at the ASM this year.

Interesting that the author worked as a cancer researcher in the UK from 2003 to 2022 and didn't mention DCVax-l or even the immune system antibody approach to treating brain cancer in the article about brain cancer new approaches.

I told you the court case was DOA. 3 million to worthless lawyers for NOTHING. 1 million to linda worthless for NOTHING. Salaries for the nonmanagement clown crew of mute morons FOR NOTHING.

Especially since most things that come out of her overpaid nonworking mouth are lies. Mute, inept, and a thief.

I think it simply means less delay.

I don't follow the whole mmtlp thing, but I see the bankruptcy trustee is subpoena-ing citadel.

So good for them, and maybe nwbo

I hope they don't issue any PR Friday evening . Those are always bad news 

The denial is a huge psychological blow to the Defense. KG must have dropped everything and call them, and proceeded to tear them a new one.

There’d have to be a new request, the old one/motion is terminated.

Regardless, defendant’s request for oral arguments is preserved for appeal.🤗🙄

I'm just putting it out there is all. I don't expect them to move forward with oral arguments.

How could I know? I hope there is detailed nondilutive funding announced concurrent with any approval, and/or details of nondilutive milestone funding. It would be most helpful.

But you agree that there will be no non dilutive funding from big pharma. Thats what I meant.

skitahoe,

Just don’t forget the word “franchise”. That takes a great deal of the load off of NWBO while still maintaining the rights to ALL indications. Seems like quite the pension plan for someone who still might want to be an “interested party”; ). Best wishes.

Doc, I believe that we're far from knowing all the benefits of DCVax-Direct. Remember, at least at first Direct is intended for patients with inoperable cancers, which I would gather to be more advanced cancers. By that time the BP's will have already sold all sorts of products for their treatment, unless DCVax-L has eliminated the need for at least certain products before then.

I believe that we all believe in time that DCVax-Direct could have tremendous benefits if employed before surgery. I would hope that given well before surgery it migrates to the mets, which can't be found, seen, or removed during the surgery. It's the mets that often have the cancers reoccur many years after what was believed to be a completely successful treatment years before as the cancers return in different organs.

Hopefully making the vaccine from the tumor after surgery will also go after the mets, but I would hope that Direct could play a big part if used prior to the surgery.

I still suspect that in time one or more of the BP's will want to partner, or acquire NWBO. I would hope it's partnerships as that will give them greater equity as the company grows, but still permit our investment to grow dramatically. If we're bought out, while very profitable to us, it immediately ends our growth, and creates a tax consequence, unless we can choose to take stock in the acquiring company.

Gary

>>“In brain cancer, a 600-patient trial may take half a decade from start to finish,” he says.

Defendant’s pending motion for oral arguments is terminated. The original request was ignored. Again, the second request was denied and that motion terminated.

What do you think happens next:

1. A judicial ruling on MTD

Or

2. A third request for oral arguments by defendant???
🥴

All this talk about settlement before discovery. I really hope they don't settle and discovery shows all. Sometimes its not about the money sometimes it is seeing the pain in the bullys face.

DJPele,

Looks to me like the issue is that the graphs used by the defense to petition for oral arguments do not take into consideration all the possible scenarios that plaintiffs are alleging but rather that spoofing was just done to buy at an artificially depressed price and sell later for a gain. Plaintiff is apparently being given the opportunity to provide proof that other interactions occurred that actually created the damage. If not convinced, the judge could agree to the request for oral arguments later. Best wishes.