Northwest Biotherapeutics Inc (QB) (NWBO) News

They will skip the ASM, as they have done in the past with zero enforcement. Mute inept and in hiding is what they are going to continue doing. Fucking clown show.

In their universe AI will give approval as well

In my opinion they can argue that they believed that CHM will give favorable recommendation , so they didn' t have to PR till final decision is made . But who knows . They have been behaving as if it is a private company personally owned by them . 

Dead stock crawling now. The asshat ceo is hiding bad news.

The total dilution for this month so far is 5,117,673 shares, which is the lowest we've seen in recent months.
To me, this supports my theory that they have been referred to CHM.
completely utter rubbish conclusion, just laughable. When they sell a lot of shares, you are complaining (and so am I with good reason) and when they sell a lower number, you are complaining.

Your correlation between a low number of shares being sold and the idea that no one wants to buy them because of a CHM referral is more than laughable. I’ve seen better logic from an eight-year-old. If anything, the silence and reduced dilution could just as easily point to an embargo period during a pending MHRA decision — or simply cautious capital management while they wait. This isn’t inherently bullish or bearish — but calling it an “indication” of trouble? That’s laughable unless it’s backed by something real.

Btw my contact spoke with Les last week. They are fully prparing still for commercialization so he was told (for whats worth)

And btw if its true what you say and those that finance the company have been told in an NDA about the MHRA having big doubts about approving, then there would be huge selling volume for that kind of news would not be convined with a small group. They would sell and so would their friends.

Denial for you is a river in Egypt.

I should have gotten back into gns at .21. Instead, this stinking POS is being destroyed by a worthless ceo grifter and trapped many.

Exactly. The worlds worse mute inept ceo and nonmanagement are hiding some painful truth, and once revealed will be buried in lawsuits.

General question: What could it imply if someone consistently sells a large block of shares right at the end of the trading day? I've been noticing this on a penny stock over the last 4–5 business days - someone seems to be dumping nearly 40% of the day’s total volume (in one transaction) right at the close.

I think the company believes it is protected from needing to PR the referral by its prior statements confirming that they will not discuss the status of the application until the MHRA has made its decision. The MHRA, even if the MAA has been referred to CHM, still has not made a decision.

I hope that is not true since I certainly believe it would be considered a material event by everyone since the news of it would certainly impact share price.

These AI generated "research" post's are getting on my nerves. They extrapolate data while ignoring nuances.

So tell us what’s left then?

>>It seems company running out of shares to dilute is latest fud narrative.

I always like to take in a broad view. I can see the rationale here: for GBM alone..... not including every other Cancer out there..... Also another reason I believe MHRA is taking longer is that NWBO is rolling in a broader approval for more cancers than just GBM.... IMHO— Bo Miha (@bohsie) June 23, 2025

Gilead also paid 21B for Trodelvy when they didn't have an approval in place. So there's immense upside from this manipulated dumpster fire market capitalization that's for sure.

Yes, a label expansion makes sense given Specials, Nature PII, and Proteomic MOA data.— autologous assassin (@DCVaxDefender) June 23, 2025

I will say it again, if there is any doubt about dc-vax, then it would be pulled from compassionate care use and we would hear about it immediately. There are many theories why the delay, my personal belief is that the approval will be sweeping. More than the application asks for or the application was amended for more than Glio. If this is the case, MHRA definitely has to dot every I and cross every T. This has gone on too long, IMO, to be just a simple approval.
It seems company running out of shares to dilute is latest fud narrative.

Ooooooooo, say it ain't soooooooo

LOL, counter arguments! Look at the share price. Can’t you see LP has been bending over backwards for so many months and years, but still can’t convince a single big pharma or credible institutional investors to support NWBO. If she had data from a secret trial, you’d think she would have disclosed it on NDA and gotten boat load of funding. Nothing to show! No interest in DCVAX technology while endless dilution in .20s and .30s continues for months.

Also EDEN BS has been exposed many times. It won’t get commercially approved in 2026. So anyone BSing around that are just pathological liars like LG, Zivic, Andrew, and many more!

If we do not have approval in August then I’d also
lean towards your thought process. Either way, a lawsuit is inevitable this Fall.

Here is what Grok3 has to say on the subject.

This suggests that CHM is likely to be involved for possibly positive or negative reasons, but likely to be involved.

Does the MHRA refer all MAA recommendations to the CHM both positive and negative?




The Medicines and Healthcare products Regulatory Agency (MHRA) does not refer all Marketing Authorisation Application (MAA) recommendations to the Commission on Human Medicines (CHM) for both positive and negative outcomes. The referral process depends on specific circumstances outlined in the MHRA’s guidance and procedures. Here's a detailed explanation based on available information:

Positive Recommendations: The MHRA typically does not refer all positive MAA recommendations to the CHM. If the MHRA’s assessment concludes that the application meets the necessary quality, safety, and efficacy requirements and the risk-benefit balance is positive, the application may proceed to approval without mandatory CHM consultation. However, the MHRA may consult the CHM or its Expert Advisory Groups (EAGs) during the assessment process for complex or innovative applications (e.g., new active substances, biosimilars, or applications for conditional or exceptional circumstances authorisations) to seek advice on quality, safety, or efficacy. This is particularly common during the initial assessment phase (up to Day 90) or for applications under the rolling review or 150-day assessment processes. If the application is straightforward and approvable after resolving any issues (e.g., through responses to Requests for Further Information (RFIs)), the MHRA can grant the authorisation without further CHM involvement.
Negative Recommendations: The MHRA is more likely to refer an MAA to the CHM when it proposes to refuse the application, particularly if there are unresolved major objections or deficiencies that present a potential serious risk to public health. For example, if safety, quality, or efficacy concerns remain after the applicant’s responses to RFIs, or if no response is received within the specified timeline (e.g., 60 days for established medicines), the MHRA may refer the application to the CHM for advice on refusal. In such cases, the CHM provides a provisional opinion, and the applicant receives a letter outlining the reasons for potential refusal. The applicant then has the opportunity to make written or oral representations to the CHM. The CHM’s final advice informs the MHRA’s decision to grant or refuse the MAA.
Specific Scenarios:
For applications under the International Recognition Procedure (IRP), if major objections persist at Day 110, the MHRA seeks formal advice from the CHM on approvability, reverting to the standard 210-day national procedure timetable.
For established medicines, if deficiencies are considered to pose a serious public health risk or if no response is received within 60 days of an RFI, the MHRA refers the application to the CHM for advice on refusal.
For Article 29 referrals (related to mutual recognition or decentralised procedures), the MHRA may adopt the CHMP or CMDh opinion (positive or negative) unless UK-specific changes are needed, but this applies specifically to Northern Ireland until 31 December 2024, and from 1 January 2025 for UK-wide applications under certain conditions.
Exceptions and Context: The MHRA’s decision to consult the CHM depends on the complexity of the application, the nature of the medicinal product (e.g., new active substances, biologics, or advanced therapies), and whether significant issues arise during the assessment. For instance, applications for conditional marketing authorisations (CMAs) or exceptional circumstances MAs may involve CHM consultation to assess eligibility or unresolved issues, but this is not automatic for all positive recommendations. The CHM’s role is advisory, and the MHRA makes the final decision, considering CHM advice when it is sought.
In summary, the MHRA refers MAA recommendations to the CHM primarily when there are significant concerns (e.g., potential refusal due to safety, quality, or efficacy issues) or for complex applications requiring expert input. Positive recommendations may not always require CHM referral unless specific issues or complexities arise during the assessment process. For the most accurate and up-to-date guidance, applicants should refer to the MHRA’s official website or contact RIS.NA@mhra.gov.uk for clarification.

They must be in the process of closing another debt round that likely refinances an existing deal and tacks on $ and term. The size and terms of that deal if it is in the works and disclosed shortly should be telling on when we might expect an MHRA decision

"I'm saying nothing with certainty."

exactly, just pure bs made up speculations that swing to the negative for nothing other than nefarious purposes.

Do you know what if anything is reserved for a poison pill?

Appreciate you sharing your insight — thank you!

i dont think the C shares that will eventually convert are included in the 1.455. I think all in we are close to already AS saturation.

They can also reverse split while leaving what’s left of the authorized “as is”. It’s a sneaky trick sometimes played on poor retail. But with NWBO’s authorized being depleted so rapidly, I’m not sure that would work. LP will likely pump moving to the Nasdaq as a reason for needing the reverse split. After that whether she does or not is a whole other story.🤷‍♀️. It’s that or LP bows out in a reorg or it goes private (Both will surely benefit Advent).🤷‍♀️

The total dilution for this month so far is 5,117,673 shares, which is the lowest we've seen in recent months. It's unclear whether this is because they're running out of shares to dilute — but if that's not the main reason, then it's actually a positive sign for investors.


To me, this supports my theory that they have been referred to CHM.

I think the company believes it is protected from needing to PR the referral by its prior statements confirming that they will not discuss the status of the application until the MHRA has made its decision. The MHRA, even if the MAA has been referred to CHM, still has not made a decision.

However, when it comes to selling shares, they are likely held to a more stringent compliance. It's my belief that in order to issue new shares at this point, they would be required to sign an NDA and inform the buyer they have been referred to CHM review because that is material non-public and NWBO could not sell shares while in possession of MNP without risking a securities violation. That's why they are having trouble selling shares right now. People either won't buy because of this information, or NWBO doesn't want to disseminate this information to too many parties even with NDA's in place and therefore they are handcuffed.

There are, unfortunately, many many many indications saying the MAA is in trouble, and very few indications to the contrary.

I'm saying nothing with certainty. Either outcome is still possible. But my 90:10 for approval when NWBO submitted is now 50:50 at best, and probably leaning on the wrong side of that.

It suggests the company has a clear sense of where things are heading.

They still have to pay their bills. They can't just stop paying their bills because they have a clear sense of where things are heading. It's not like they're sitting on a mountain of free cash.

Do you know the current total share count and how much more the management is allowed to dilute?
The second part of that is very murky.

DE law restricts them to 1.7B common shares, and that is a hard limit but specifically common. So they are fine there.

But there are employee options, warrants, preferred shares and converts. Some of these require common shares to be reserved against them. But to further confuse this, failing to reserve might not even be actionable until somebody could not convert.

In short, I have no clue how many common they could issue today. It is likely a complex dance with the holders of the derivative instruments.

I am sure LP knows though. And you will find when the limit is reached when you see it on Edgar.

So, 1.7 billion minus 1,455,079,979 leaves about 240 million shares still available to dilute — but is all of that actually usable? Or are some of those shares already tied up due to previously issued warrants?

if approval drags on for months they will have no choice to rush an ASM demanding another AS raise. shareholders should make it clear that we need concessions from mgmt. we should own Advent for starters. They are posting PROFITS whle we struggle

if they ask for them selves its a big hell no, hope everyone votes like this. If its for operations then we have no choice.

1.7 billion shares are authorized.

I doubt if an Annual Meeting will be scheduled until we've gained approval, once that occurs, I would expect that they'll ask shareholders to authorize a substantial increase in authorized shares.

Gary

underpar71 Thanks..

Do you know the current total share count and how much more the management is allowed to dilute?

Given the safety profile, nobody knows what MHRA will do. Conformational trials would make sense as many individuals simply will not permit Chemotherapy

You can't dilute if volume is collapsing.

🤷🏻‍♂️

Thanks EX, it's more than I've seen, but I'm not into all that's not provided in PR's.

The key is approval, anything less than that would hurt. If the approval has conditions, I'm fine with that. The company can sell the vaccine and use some of the funds to meet whatever conditions are required.

I don't expect conditions if the approval is for GBM, but should we get a tumor agnostic label, I would expect the regulator to place some serious demands on the company for additional trials to validate their judgement.

Of course, we all anticipate further trials to demonstrate how much more effective DCVax-L can be when combined with others like Poly-ICLC and/or Keytruda, and perhaps others. I don't know if the regulators will accept these trials as being confirmational.

Gary

https://mhraproducts4853.blob.core.windows.net/docs/8dcbd83799317a10cfe5a2551123b649e6541609

The only thing I have ever seen from regulators is there decision, how they arrived at it has never been discussed.
For the FDA, one can often find details when published per a FOI request., This is really an excellent source of information on how the staff reviews really work. Other than that, one can look to ADCOM briefing material.

For EMA, once approved there is a published PAR report.

For MHRA, once approved there is supposed to be a PAR report, but I have never seen one. Suspect a post Brexit issue. One note, sponsors can withdraw the MAA prior to final rejection and avoid a public report.

The total dilution for this month so far is 5,117,673 shares, which is the lowest we've seen in recent months. It's unclear whether this is because they're running out of shares to dilute — but if that's not the main reason, then it's actually a positive sign for investors. It suggests the company has a clear sense of where things are heading.

06/17/2025 - 06/23/2025 (25,000)
06/16/2025 1,455,054,979 (+1,609,091 = 129,148,013 YTD)
06/12/2025 1,453,445,888 (+675,917 = 127,538,922 YTD)
06/09/2025 1,452,769,971 (+1,000,000 = 126,863,005 YTD)
06/06/2025 1,451,769,971 (+412,632 = 125,863,005 YTD)
06/05/2025 1,451,357,339 (+674,158 = 125,450,373 YTD)
06/02/2025 1,450,683,181 (+720,875 = 124,776,215 YTD)

Did ESMO ever score DCVAX?🤷‍♀️

https://www.prnewswire.com/news-releases/accord-healthcare-receives-approval-for-hetronifly-serplulimab-from-the-medicines-and-healthcare-regulatory-agency-mhra-for-first-line-treatment-of-extensive-stage-small-cell-lung-cancer-es-sclc-302488662.html

Would love to hear from Ashkan on his opinion of this MHRA delay. would feel better if he affirmed the independence of MHRA from Wall St/BP influences.

The company has a law suit against 7 MMs which have immense resources. Those companies would pounce on ANYTHING they could to damage NWBO more than they already have.

I don't like the silence from the company, but I do understand it.

The MHRA decision is taking much longer than expected for whatever reason. That makes the silence more difficult to endure. The reason for the silence hasn't changed.

IMHO

If and when there is a public hearing, like an ODAC meeting, briefing documents have the FDA’s concerns, at least. But it’s right that this is the exception to the typical silence

They will ask for an AS raise and even bigger bonuses i bet

Absolutely right , who trues up my shares that I bough higher. This thieving mgmt should be giving any and all options back.

imagine the folks collecting 6 figure salaries and doing virtually nothing day in day out week after month after year. Sickening

The only thing I have ever seen from regulators is there decision, how they arrived at it has never been discussed.   Companies don't ever discuss such issues as they must continue to work with the regulators. 
We'll get a statement that establishes where we are, and any conditions that are required in the future.   That is about it.
Gary 

Last time it did not break 1mm shares traded was 10/31/24

the company is running out of shares. How are they going to continue funding the company in July August and beyond??? we must be getting wind of an ASM sooner than later with a desperation AS raise demand. They need to cancel millions of insider options/warrants IMO. No execution = No True Ups

Like sand through the hourglass. These are the days of our lives.