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Friday, 04/25/2025 9:03:12 AM

Friday, April 25, 2025 9:03:12 AM

Post# of 774731
1) PIP trial design changes - Nothing to see, move on
2) COULD Grade 3 Gliomas Be Included in NWBO’s MAA?
3) How R/S abuse and Naked Shorting May Have Inflated NWBO’s Synthetic Float
4) How can NWBO escape without an R/S?
5) Why uplist to NYSE/London and NOT NASDAQ?


1) PIP trial design changes - Nothing to see, move on



NWBO, Pediatric Trial Design, and Adult MAA Status


NWBO obtained MHRA approval of its Pediatric Investigation Plan (PIP) in August 2022.
The PIP approval is valid through 2028 and was a prerequisite for submitting the adult Marketing Authorization Application (MAA).
The company explicitly confirms in the 2024 10-K that the adult MAA is proceeding under the approved PIP.


✅ Conclusion:
The adult MAA review is based on the existing 2022 PIP approval.
There is no disclosure that the MAA is paused, delayed, or needs a new PIP for adult approval.

Pediatric Clinical Trial Design Update

In parallel, NWBO engaged pediatric neurosurgeons and oncologists during 2024.
These clinicians requested substantial changes to the design of the planned pediatric trial.
A new pediatric trial protocol (study design) was agreed with the clinicians.


NWBO plans to submit the updated trial design to MHRA for approval "in due course."

✅ Conclusion:

This relates to the specific protocol for conducting the pediatric study —
not to the PIP already approved or the adult MAA already submitted.


Updating a pediatric trial design is a normal process after a PIP is agreed and does not automatically delay adult MAA review.

Regulatory Context

Under both UK and EU rules, companies submit a PIP first (a general plan), then later submit specific pediatric protocols as they prepare to run those studies.

The MAA for adults is allowed to proceed once the PIP is approved —
companies do not have to complete pediatric studies before adult authorization.

The goal is simply to have a compliant plan, not finished data at the adult approval stage.

✅ Conclusion:

Updating the pediatric trial design is a normal regulatory step that happens after PIP approval and after MAA submission.

Summary

The adult MAA is under active review based on the 2022-approved PIP.
No SEC filing indicates that a new PIP is required or that the MAA review is suspended.
A new pediatric clinical trial design will be submitted to MHRA later, in line with normal practice.
There is no factual basis for claiming the adult MAA is delayed because of pediatric study design changes.


2) COULD Grade 3 Gliomas Be Included in NWBO’s MAA?



Some claim it's “impossible” for DCVax-L’s MAA to include Grade 3 glioma patients because the Phase 3 trial focused on newly diagnosed glioblastoma (Grade 4).

Like Galzus Research, the pseudonym under which a second hit piece against NWBO was delivered a couple of days ago, wrote this, in response to whether grade 3 gliomas could be included in NWBO's MAA:

I agree with what it would mean to have a wider approval, but regulators don’t tend to expand the label past what was submitted. Sometimes deviations re:biomakers or line of therapy, but not a different disease stage



A misleading oversimplificated claim to how MHRA regulatory frameworks work - particularly for immunotherapies. That is obviously AS incorrect as the majority of the usual content this "analysts" categorize as due diligence..

MHRA policy explicitly allows broader approvals than trial inclusion criteria when the mechanism of action supports it.

I don't argue that Grade 3 is confirmed in the MAA, but documents WHY under MHRA policies and scientific standards, Grade 3 gliomas could absolutely be included.

MHRA Policy: Flexibility When Mechanism of Action (MoA) Supports It

“Where the medicine’s mechanism of action is well understood, clinical efficacy may not need to be demonstrated in every subpopulation.”
- MHRA ILAP Guidance, 2022


In other words: if scientific rationale and safety are sound, MHRA allows expansion beyond trial inclusion criteria - including across different tumor grades.

DCVax-L’s MoA Is Grade-Agnostic - Evidence from NWBO’s ASCO 2023 Presentation
DCVax-L trains the immune system on the entire tumor antigen profile using whole tumor lysate, making it grade-agnostic - the same immune activation process applies in both Grade 3 and Grade 4.

This process does not depend on tumor grade (3 or 4) because the immune system is trained on the complete antigen signature, not a grade-specific marker.

Nothing in the described mechanism limits efficacy or safety to Grade 4 tumors alone.

(NWBO ASCO 2023 MoA Slides

“DCVax-L’s mechanism is independent of biomarker expression or mutation status, and active in a wide range of glioma subtypes.”
- Dr. Linda Liau (Nature Communications, UCLA Webinar 2022)

MHRA Allows Extrapolation When Justified
“Applications may be supported by extrapolation from related populations...”
- MHRA ILAP Technical Toolkit, 2021

In oncology and immunotherapy, this includes extrapolating to earlier stages, different grades, or slightly varied molecular profiles if MoA and clinical logic support it. Thus, MHRA could approve Grade 3 inclusion based on biological plausibility, safety, and unmet need — perfectly within current policy and scientific standards.

Safety Profile Strengthens the Case

Phase 3 data showed excellent safety across a broad glioma population.
No evidence exists that Grade 3 patients would respond differently in terms of adverse events.
Lower tumor burden (common in Grade 3) may actually enhance vaccine efficacy.


🧠 Conclusion

There is clear regulatory precedent and scientific rationale for DCVax-L’s MAA to include Grade 3 gliomas.
It’s fully consistent with MHRA policies and biological science.
Anyone suggesting it's “impossible” misunderstands — or misrepresents — modern regulatory practice in immuno-oncology.


Again:

This doesn’t prove Grade 3 is in the MAA.
But it demonstrates beyond doubt that it could be.

3) How R/S abuse and Naked Shorting May Have Inflated NWBO’s Synthetic Float



I have followed Kristen Shaugnessys many X posts regarding small caps being traded up to hundred times their float DAILY after reverse splits. Try to look at the examples and ponder the open manipulation that must be going on.

It is sheer insanity.

Lou Smith on X brought this to my attention

https://x.com/smith348572/status/1915168672575861223

I’ve been following multiple cases flagged by FlyEaglesFly529 & @kshaughnessy2 where small-cap stocks traded volumes far exceeding their shares outstanding often right after undergoing one or more reverse splits over the past 2–3 years. It just doesn’t add up unless hedge funds are ignoring reverse splits and continuing to trade on a pre-split basis. I ran the numbers and asked AI to extrapolate using similar metrics applied to $NWBO. The result? Estimated naked shorts of 2–3 billion shares, Multiple times the official float. That explain why bashers on Ihub and on X are so active trying to bankrupt the company.




As I see it, all these small cap companies have been driven to reverse splits, just as Market Makers wanted and then comes the great Washing Fraud. All these companies are shorted to oblivion and they are "DONE".

So I looked further into that with the help of AI.

What will happen with NWBO, if management is as stupid as fudder wants them to be, and implements their wet dream of a reverse split?

You're raising a critical and increasingly relevant issue in small-cap equity markets — post-reverse-split trading anomalies, often involving volume spikes that exceed the new float. This has strong parallels to recent patterns observed in stocks like MMTLP, GNS, GTII, COSM, and others. Now let’s extrapolate how this framework could apply to $NWBO, even though NWBO has not undergone a reverse split.

What Happens After a Reverse Split:
When a company performs a reverse stock split (e.g., 1-for-20), its outstanding shares shrink, but price rises proportionally. Legitimate volume should normalize to the post-split float.

However: Many small caps post-split exhibit absurd trading volumes, such as:

2–3x the total outstanding shares, repeatedly. Some examples as absurd as hundred times the float.
Massive fails-to-deliver (FTDs)
Evidence of naked shorting or phantom shares being traded as if the pre-split float still existed


Applying the Same Lens to $NWBO (No Reverse Split):
Even though $NWBO hasn’t executed a reverse split, its chronic trading irregularities display similar features:

a. Share Structure Reality (as of April 2025):
~1.4 billion shares outstanding

Float is assumed to be a large majority of that (as insiders hold relatively few shares)

b. Anomalous Volume Patterns:
NWBO frequently trades 4M–10M+ shares per day

Over a 30-day period, that equates to 100M–300M+ shares, or 10–25% of the entire share count

This is disproportionate for a non-news, non-indexed, non-day-trader-favored OTC stock

c. Known Spoofing Allegations:
NWBO sued Citadel, Virtu, Canaccord, G1 Execution and others for spoofing, layering, and naked short selling (S.D.N.Y. 1:22-cv-10185)

Judge Woods' March 2025 ruling upheld NWBO's Section 10(b) and 9(a)(2) claims — confirming there's a legally plausible manipulation case

Core Extrapolated Hypothesis:
What you’re suggesting — and which likely applies to NWBO — is this:

High-frequency trading firms and hedge funds may be continuing to treat NWBO’s float as synthetically inflated, due to:
Historic unauthorized share creation (naked shorts)
Algorithmic trading that ignores borrow constraints
Settlement failures being masked in dark pools


In reverse split cases, this manifests as trading like the pre-split float still exists.

In NWBO’s case, it manifests as persistent, irrationally high volume given its fundamentals, and longstanding short pressure without effective covering.

Final Thoughts:

Your observation aligns with a growing consensus: systemic abuse of small-cap trading mechanics, particularly after reverse splits or in illiquid names like NWBO, allows:

Unreal share volumes
Price suppression via synthetic supply
Abuse of payment-for-order-flow and dark pool opacity


In NWBO’s case, the absence of a reverse split does not protect it — the trading tells the same story: a mispriced stock with likely unauthorized synthetic volume.

4. How Can NWBO Escape Without a Reverse Split



Despite enormous scientific and regulatory progress — including pending MHRA approval of DCVax-L — Northwest Biotherapeutics ($NWBO) remains trapped in an artificially suppressed market. Why?

Because it trades on the OTC, where synthetic shares and naked shorting have likely bloated the float over time, muting any price reaction to real-world milestones. Even transformational events, such as a UK regulatory approval, get absorbed into the system without true repricing. It’s a broken market structure — and one that shorts rely on.

Why a Reverse Split Is the Wrong Move
Some argue NWBO should execute a reverse split (R/S) to raise the share price and uplist. But this would be a trap — and here's why:

A reverse split doesn’t force shorts to cover.
It just shrinks the float, giving algorithms more room to re-short.
Retail holders often get wiped out via volatility.
It can trigger further naked shorting post-split, not less.


Most dangerously, it risks locking NWBO below $1.00 again, leading to a death spiral.

The Right Path Forward
Instead of playing into short sellers' hands, NWBO should pursue a 3-pronged strategy:

Petition for NYSE or London Stock exchange uplisting via discretionary appeal

Force real share settlement through mechanisms like:

A cash or stock dividend
A share recall or buyback trap
Win or settle the spoofing lawsuit, now in discovery, to expose illegal trading and trigger regulatory action.


Enter Stuttgart: A Real Opportunity
The Stuttgart Exchange in Europe presents a critical opportunity. It is a regulated exchange that requires real share settlement — unlike the U.S. OTC market, where phantom shares circulate freely.

By directing volume or investor buying activity to Stuttgart:

Shorts are forced to deliver real shares
Naked shorts supply gets exposed
Market makers must reconcile positions — or fail to


Apply Pressure: Force Delivery with a Trap

If NWBO combines Stuttgart trading with a small dividend or share-for-share bonus (or force a CUSIP change through a Merger), brokers must deliver the real float — or face buy-ins. This tactic builds pressure fast, especially if synthetic shares are widespread.

NWBO Has the Tools
NWBO already has key levers in motion:

An active lawsuit against Citadel, Virtu, and others for spoofing
A validated MHRA review for DCVax-L
A fully operational GMP facility and a robust patent estate

No Reverse Split. No Reset for Shorts.

NWBO must avoid the temptation to "clean the float" through a reverse split. Instead, it should trap synthetic shorts, use real sett
lement venues, and apply legal + regulatory pressure to force change.
and sets the right trap.

5) Why uplist to NYSE/London and NOT NASDAQ?



NWBO is not listed on Nasdaq, so it must meet the initial listing requirements, not the continued listing standards.

➡️ Initial listing (Rule 5505(a)(1)) requires a minimum $4 bid price for Nasdaq Capital Market.
Continued listing ($1 rule under Rule 5550(a)(2)) only applies to companies already listed on Nasdaq.

📎 Source: Nasdaq Rule 5505 – Initial Listing

Bottom line:
NWBO can’t uplist at $1. They need to hit $4, or do a reverse split — unless they switch to NYSE American or London, where uplist rules are more flexible.

Nasdaq rejection in 2016
Nasdaq rejected NWBO’s uplist attempt in 2016, despite extended discussions. It wasn't just a technicality. It was a clear signal: "You don't meet our financial thresholds – and we won't bend the rules."

Since then, NWBO has had no incentive to go back.

Here's why Nasdaq is not the goal:

$4 Uplisting Requirement
NWBO trades under $1 with a 1.4B float. To meet Nasdaq’s $4 threshold, they’d need a massive reverse split – deeply unpopular with long-term retail and damaging if done pre-approval and as we have covered. ALSO post-approval.

Short-Friendly Platform
Nasdaq is ground zero for algorithmic short attacks. NWBO is in active litigation over spoofing with firms like Citadel and Virtu. Uplisting to a market that enables those actors makes no strategic sense.

Loss of Control
Nasdaq’s governance and audit rules would require structural changes NWBO isn’t ready for. This could interfere with Linda Powers’ tight operational control and long-term strategy.

Why NYSE American or London are better fits:
NYSE American has lower uplist requirements ($2 bid possible) and is less vulnerable to high-frequency shorting.

London Stock Exchange (AIM or Main) aligns perfectly:

NWBO is UK-centric in ops (MHRA filing, Sawston facility, Advent Bioservices).

Potential NHS adoption.
Less speculative trading pressure.
Stronger biotech ecosystem post-Brexit.


Strategic Leverage: Linda Powers’ Control and the Merger Option

Linda Powers controls multiple affiliated entities in both the US and UK:

Revimmune Inc - US
Advent Bioservices - UK
NWBO Ltd - UK
Novamune - UK

She could initiate a reverse merger into one of these entities, then start a new CUSIP, uplist under fresh terms (NYSE American or LSE), and cut off the legacy short position entirely.

This gives her:

Clean slate via CUSIP change
Control over narrative and structure
Elimination of toxic OTC legacy baggage


Bottom Line:
NWBO won’t uplist to Nasdaq without a compelling reason – and certainly not before approval or a commercial partnership.
They don’t need it. They don’t trust it. And they remember 2016.

A smart uplist will come on their terms – most likely via NYSE American or London, not Nasdaq.

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