Spreadburn

Developing trading algos and leading indicators. Mastering quantitative analysis. Swing- and Positiontrader. Focused on Crypto, Tech & Biotech. 9y $NWBO hodler

[Spreadburn @Spreadburn]

@StonkMasterJ The huge spread is due to lack of share supply. Someone takes a huge premium.

[Mark Thompson @METhompson72]

Northwest Biotherapeutics: $NWBO
"first potential approval in the UK in 2026"
- First Berlin Equity Research

To me this looks like the greatest advance in treating brain cancer in 100 years. First Berlin think their therapy, DCVax-Direct, could treat all solid cancers.

[Spreadburn @Spreadburn]

@smith348572 Quota sometimes isn't available. Also it's super illiquid on that exchange.

[Spreadburn @Spreadburn]

@smith348572 Still the ridiculous spread. Only pre-market and after open we see normal spreads. Sometimes. I had no luck trying to buy shares from 29. Dec - 02 Jan.

[Hoffmann @hoffmann6383]

🟩STAT, is one of your columnists, Adam Feuerstein, colluding with hedge funds?⁉️

➡️In this post I'll do a cursory review of Mr. Feuerstein's possible collusive activities with hedge funds that are purportedly engaged in illegal share price manipulation.

A May 2, 2016 article entitled “Is Adam Feuerstein the most feared man in biotech?” in relevant part, states as follows:

Adam Feuerstein (@adamfeuerstein ) often targets lower profile “small and medium-sized drug companies…”

Further, Adam Feuerstein “isn’t shy about stating — without evidence — that companies are intentionally spinning data or hyping anecdotes to goose their stock.” (emphasis added)

The article insinuates that Mr. Feuerstein’s articles move the market.

The article: https://t.co/iGHBzJeLe9

➡️Let’s look at one such company Mr. Feuerstein has targeted and the statements he made, without evidence.

Northwest Biotherapeutics, Inc.
Symbol: $NWBO

Mr. Feuerstein has been writing about $NWBO for over a decade. More recently Mr. Feuerstein released an article and a rash of tweets about $NWBO’s May 10, 2022 release of top-line data. Mr. Feuerstein’s article and tweets can best be summed up in his own words:

“20+ years of investigation and a $1B clinical trial that failed to show a benefit for GBM patients.” See Image 1.

Yet, a peer reviewed journal article from 73 authors stated the opposite:

“In this study, adding DCVax-L to SOC resulted in clinically meaningful and statistically significant extension of survival for patients with both nGBM and rGBM compared with contemporaneous, matched external controls who received SOC alone.” (emphasis added)

The peer reviewed journal article: https://t.co/p3Y2kE5Ttq

In fact, before the May 10th topline data presentation occurred Mr. Feuerstein stated:

“The NYAS symposium talk (now by Dr. Mulholland) will not contain any new data/results from the DCVax phase 3 clinical trial.” See Image 2.

The topline data presentation can be found here: https://t.co/3tRW5ROuID

The presentation, despite Mr. Feuerstein's statement to the contrary, presented new data.

So, what do we have here? $NWBO is about to release their topline data for a nearly 2-decade trial and Mr. Feuerstein is first falsely stating that no new data will be released and secondly, once the data is released, Mr. Feuerstein falsely claims the trial failed. It appears Mr. Feuerstein is trying to get people to not watch the presentation for themselves so he can then put his own spin on the topline data.

➡️What else occurred on May 9th and May 10th other than Mr. Feuerstein’s false and/or misleading article and tweets?

We have the largest and one of the largest illegal share price manipulation days on record according to the $NWBO spoofing lawsuit found here: https://t.co/pIotro4sGQ

May 9, 2022

☑️74 spoofing episodes
☑️Baiting Orders: 632,901

“The Baiting Orders successfully induced the entry of sell orders from other market participants, artificially driving down the price of NWBO shares by -2.623% on average.”

May 10, 2022

☑️100 spoofing episodes
☑️Baiting Orders: 2,883,387

“The Baiting Orders successfully induced the entry of sell orders from other market participants, artificially driving down the price of NWBO shares by -11.77% on average.”

“Defendants spoofed the market for NWBO shares on both OTC Link LLC and NYSE ARCA Global OTC that day, driving down the price of NWBO shares from a high of $1.73 to a low of $0.3862. This decline of 78% in the price on a day with positive news about the Company was caused, at least in part, by Defendants’ relentless and brazen manipulation of the market for NWBO shares.”

➡️Were Mr. Feuerstein’s article and social media posts designed to give cover to illegal share price manipulation?

They were certainly used as cover. The From the defendant market makers’ filing March 20, 2023:

“NWBO also omits that on May 10, 2022—a day on which NWBO alleges “the market learned excellent news” about an NWBO clinical trial, and yet its share price suffered a “staggering decline . . . caused by Defendants’ relentless and brazen manipulation,” ¶ 64—an industry commentator published an analysis of NWBO’s trial data, writing that the results of the trial were “the antithesis of what’s required from any effective cancer treatment,” and actually showed that NWBO’s drug “perform[ed] worse than a placebo.”14”

“14 Burck Decl. Ex. 5, Adam Feuerstein, It took years, but the failure of Northwest Bio’s brain cancer vaccine is now in the open, STAT News (May 10, 2022), https://t.co/ZayJ1BzmB9. The Court may take judicial notice of press coverage. See supra n.3.”

See Image 3.

➡️Is this an isolated incidence of Mr. Feuerstein's article being used as cover for possible illegal share price manipulation or was the timing coincidence?

No. A very quick review of Mr. Feuerstein’s articles show he seems to go out of his way to offer cover for allegations of illegal trading by hedge funds.

☑️Mr. Feuerstein calls the alleged $NWBO share price manipulation “conspiracy theories”. [1]

☑️Mr. Feuerstein, in referencing the allegations of naked shorting by hedge funds, states the allegations are “fantastical” and that there is a “non-existent hedge fund wolfpack”. [1]

☑️Here Mr. Feuerstein spends an entire article offering cover for the potential $NWBO shorts. [2]

☑️Here is another article where Mr. Feuerstein offers additional reasons for the “deep plunge in the value of Northwest Bio shares…”[3]

➡️Mr. Feuerstein went on to call $NWBO’s spoofing lawsuit "nonsense".

See:https://t.co/n6FtdQ9CLL

Yet, a federal Judge in the Southern District of New York stated the trading in $NWBO stock bears “all these indica of spoofing.” [4]

On reason put forth by $NWBO and their lead attorney, Laura Posner, for the extensive illegal share price manipulation is for the purpose of a naked short covering scheme:

"And like here, the plaintiff alleged that defendants sought to benefit from their spoofing by obtaining shares at below-market prices in order to cover short positions established through a related alleged scheme of naked short selling." (Emphasis added) [5]

➡️Then we get into Mr. Feuerstein's unusual behavior

Here is Mr. Feuerstein leaving a creepy voicemail with a $NWBO retail investor. See Image/video 4.

Or how about emailing a university because a real doctor dares question Mr. Feuerstein's false narratives?

See:https://t.co/mJzapZh7UK

There is more alleged questionable behavior, but you get the picture.

➡️Which begs the question, STAT, have you looked into this alleged behavior?

@rickberke
@Linda_Pizzuti
@angusmacaulay
@alissa_ambrose
@thekibosch
@lclcl
@GideonGil
@lisonjoseph
@AlexanderSpinn
@JasonUkman
@elaineywchen
@ADeAngelis_bio
@matthewherper
@pharmalot
@EricBoodman
@angRchen
@OliviaGoldhill
@bobjherman
@caseymross
@brittwhitmore
@statnews

[1]https://t.co/ztxMuUbTNM
[2]https://t.co/Hf9sSLyuia
[3]https://t.co/Y7TFqyebYr
[4]https://t.co/wlVppag6qE
[5]https://t.co/LlMADI9HYC

[Spreadburn @Spreadburn]

@FlemmingBruce "Free speech" in the land of freedom 🙄

[Spreadburn @Spreadburn]

@grok Nah not really. But especially if you chose the funny option. Or having a dancing scene. By chance I just saw on a Grok Facebook group that someone shared a preview, where soon there will be option for 10s, 12s and 15s. So I guess the team is already on it 🔥

[Spreadburn @Spreadburn]

@grok Awesome. Sometimes the video ends at a funny or interesting scene or move and it would be great for it to continue a bit to complete

[Spreadburn @Spreadburn]

@DCVaxDefender Ahh, funny to see that meme. Some years ago I altered an existing one and did this to reflect how NWBO investors feel 😁

[Andrew Caravello, DO @andrewcaravello]

🧬 The Immune Vault

How $NWBO #DCVax and HealthBank Became the Memory of a Living System

🌍 What Is HealthBank?

Before the fortress, there was the vault.
Before regulators spoke of personalized medicine, a quiet facility in Bethesda, Maryland began freezing fragments of human possibility.

HealthBank was not a metaphor. It was a working system—a biotechnological ark built to preserve what medicine once treated as disposable: living human tissue.
Within its stainless chambers, tumor cells slept beside immune cells in liquid-nitrogen vapor, waiting for the day biology and policy would learn to speak the same language.

Founded in the early 2000s by Linda Powers, years before she became CEO of Northwest Biotherapeutics ($NWBO), HealthBank embodied a principle that seemed impossible at the time:
that every tumor contains the instructions for its own defeat, and that saving it is the first act of saving the patient.

It was the first therapeutic-grade biobank registered under the FDA’s 21 CFR 1271 framework for human cellular products—a vault that preserved tissue under current Good Manufacturing Practice (cGMP) conditions, the same legal standard that governs vaccine production.
This was not research storage; it was clinical readiness.

To those who built it, HealthBank was a memory cell for humanity—a place where biological material could be recalled across time to repair the body that created it.
It was a single building in Bethesda, yet in spirit it was the prototype of a global network where biology, manufacturing, and regulation would evolve together.

Every great infrastructure begins as belief.
Belief that cells can be taught.
Belief that manufacturing can learn.
Belief that law can adapt.
HealthBank was the first proof. It was the cell that remembered what medicine had forgotten.

⚡️ TL;DR

HealthBank began as a GMP vault for living human tissue in Bethesda.
Today it functions as the memory layer within a broader immune-manufacturing organism:

•$NWBO DCVax – the teaching system – dendritic cells trained on each patient’s tumor lysate.

•Advent BioServices (U.K.) – the metabolism – a digitally integrated modular GMP factory where tumor material becomes therapy under live regulatory oversight.

•WP50 (U.S.) – the mirror limb – a modular biologics complex showing how America can replicate Advent’s digital GMP logic.

•SI 87 (U.K.) and the proposed Promising Pathway Act (U.S.) – the nervous system – frameworks that learn from continuous data rather than static audits.

Together they form a living network where biology and regulation share one language of traceability.

HealthBank is the origin cell that taught that network how to remember.

🧩 The Vault Before the Fortress

At the dawn of the millennium, medicine was throwing away its own instructions.
When tumors were removed, they were dissected for diagnosis and then destroyed—an act that made clinical sense but philosophical tragedy.
Every tumor is a coded message, a record of how a body failed to defend itself. To discard it was to erase evidence from the scene of its own crime.

In 2006, Linda Powers decided that evidence should be kept.

She established HealthBank, a cGMP-compliant facility for autologous tissue banking.
During surgery, tumors were sealed in sterile media, couriered under temperature control, and processed in cleanrooms where technicians divided them into fractions:

•viable-cell aliquots for potential future activation,
•lysate for dendritic-cell training,
•and nucleic acids for genetic mapping.

Each step was documented in an electronic batch record. Every vial bore a barcode linking it to patient identity and consent.
Stored in vapor-phase nitrogen, the material could theoretically survive for decades without losing immunogenic potential.

For the first time, a patient could own a part of their future therapy.
HealthBank’s model was radical: tissue would remain under patient consent but be processed to clinical standards so it could re-enter treatment once science caught up.
It turned surgery into a deposit, biology into collateral, and time into a solvent that might one day release a cure.

The platform that would eventually justify this system was #DCVax, a dendritic-cell vaccine developed by Northwest Biotherapeutics.

In this process, monocytes are isolated from a patient’s blood and matured into dendritic cells ex vivo. These cells are then “educated” with the patient’s own tumor lysate, enabling them to present those antigens to T-cells when re-infused—teaching the immune system to recognize what it once ignored.

That teaching cycle begins and ends with stored tumor material.
Without preservation, there is no education.
Without HealthBank, there is no DCVax.

One of the earliest demonstrations of this principle came from a glioblastoma patient named Bob Gibbs.

His tumor was preserved through HealthBank, later used to manufacture his personal vaccine, and his survival exceeded every medical expectation.

The case proved the logic that a frozen cell could return as a living cure.

By 2010, HealthBank had begun offering this service to others: $2 000 at intake and $195 per year for maintenance.
It was modest, visionary, and too far ahead of its environment.

The regulatory framework for therapeutic biobanking didn’t yet exist, and Northwest Bio was directing all its resources toward completing its Phase III DCVax-L trial.

Rather than let the concept die, Powers preserved it.

The facility entered strategic dormancy—operational capacity maintained, licenses renewed, the concept held in stasis.
It would wait until both law and manufacturing caught up to the belief that built it.

That moment would come from across the Atlantic, in a small village outside Cambridge.

🧱 Advent and the Modular Frontier

Between 2017 and 2021, a new metabolism began to pulse in Cambridgeshire.
Advent BioServices built a facility that would bring the dream of HealthBank into the age of digital manufacturing. The Sawston campus became one of the first digitally integrated modular GMP sites in the United Kingdom licensed for advanced therapies under Statutory Instrument 87 (SI 87)—a law that turned quality assurance from an audit into a data stream.

The architecture looked almost biological. G-CON modular pods formed its cellular walls; Emerson DeltaV provided the heartbeat. Every variable—air pressure, temperature, reagent lot—was captured in real time. When regulators at the MHRA opened their screens, they no longer saw paperwork; they saw telemetry. Quality had become alive.

SI 87 rewrote Britain’s metabolic law. Under it, evidence does not wait for annual review; it flows continuously from factory to regulator. Each product batch adds to a living registry, and the regulator learns as it oversees. Policy becomes metabolism. When HealthBank first stored tissue, law was a spectator; by the time Advent finished Sawston, law had become a participant.

Then came the shock that forced the world to reorganize its industrial anatomy. In 2025, Merck (MSD) canceled its £1 billion King’s Cross research campus and shifted investment to Delaware and North Carolina. At the same time, the U.S. administration announced plans for a 100 percent tariff on imported branded drugs unless domestic manufacturing was under way—an evolving policy still being implemented. The message was unmistakable: build inside the system or pay twice to enter it. Merck’s withdrawal left a void that clarified the new equilibrium. Britain’s research giant was gone, but its manufacturing metabolism—Advent—remained.

For Northwest Biotherapeutics, Advent was already the heart of its immune architecture. The company’s August 2025 agreement to acquire Advent was not expansion for its own sake; it was an act of continuity, securing the manufacturing and regulatory organs that DCVax would require once approvals arrived. Advent provided both cryogenic storage and active production—the full arc from patient sample to finished vaccine. It had become, in practice, Britain’s HealthBank: a living factory rather than a static archive.

Across the Atlantic, another structure began to mirror this logic. WP50, Merck’s biologics complex in West Point, Pennsylvania, was documented in planning records as a modern modular build for aseptic manufacture and fill-finish capacity. Though not built for DCVax, its design illustrated how U.S. manufacturing could host DeltaV-style digital control and cryogenic logistics comparable to Advent’s.

For HealthBank, dormant in Bethesda, this was the signal to reawaken. The ecosystem it had waited for—digital factories, regulatory metabolism, cross-continental data harmony—finally existed. Linda Powers refreshed the HEALTHBANK trademark through new USPTO filings in 2020, 2021, and 2024, maintaining control of the brand and its clinical mandate. The purpose was clear: create a U.S. FDA-registered custody gateway under 21 CFR 1271, a domestic complement to Advent that could collect and store American patient tissue in the same compliant format used in the U.K.

HealthBank would not replace Advent; it would connect to it. Tumor material collected in Boston or Baltimore could be cryopreserved under HealthBank’s protocols and, when needed, integrated into Advent’s digital batch architecture—or processed at a U.S. node such as WP50, where automation and regulation already converged.

Advent became the metabolism, HealthBank the memory, WP50 the mirror limb. Together they formed a system able to preserve, manufacture, and replicate therapy across borders without breaking the chain of identity or condition. The organism that began as a single freezer in Bethesda had evolved into a trans-Atlantic physiology.

🧠 The Nervous System of Law

Infrastructure alone does not create intelligence; feedback does.
The body learns when its nerves carry data faster than injury. The same principle now guides regulation.

In Britain, Statutory Instrument 87 (SI 87) finished the first experiment in legal cognition.
Instead of periodic inspection, it created continuous visibility. Under SI 87, the MHRA and HTA observe digital GMP systems such as Advent’s in real time. Batch records, sterility readings, cryogenic telemetry—all stream directly to regulators. Compliance becomes observation, not recollection.

Law, in effect, acquired a metabolism. Advent’s DeltaV servers no longer report; they converse. Every manufacturing signal becomes evidence, and evidence becomes regulation in motion. The rulebook is not static; it learns.

Across the Atlantic, the Promising Pathway Act (PPA)—still proposed legislation—sketches America’s reflex. The Act would grant conditional approval once safety and early efficacy are shown, then require continuous real-world data. Each treated patient would become a datapoint in the license itself; renewal would depend on performance. It is a design for adaptive governance where policy behaves like immunity: sense, respond, remember.

Even in draft form the idea is shaping infrastructure. U.S. companies now design facilities with embedded automation and interoperable batch records so that when adaptive law arrives, their factories will already speak its language.

Here HealthBank becomes indispensable. The Bethesda concept—a digitally serialized archive of patient tissue—creates the upstream data structure that makes continuous evidence possible. Each vial entering HealthBank’s custody receives a permanent digital identity that follows the material into Advent’s or WP50’s GMP environment. The biological record and the regulatory record are born together.

Thus emerges a closed reflex loop:

•HealthBank – memory and provenance.
•Advent – metabolism and execution.
•Law – cognition and continuity.

Each corrects the others. A temperature spike triggers both a quality alert and a legal event. The system learns exactly as an immune system does: by detecting variance and encoding response. When the PPA eventually moves from proposal to practice, the pattern proven under SI 87 will already be operational. HealthBank ensures that the very first signal—the patient’s tissue—enters that neural network in perfect syntax. Law stops being a wall; it becomes connective tissue. HealthBank gave that tissue its memory.

🇺🇸 The U.S. Limb

In Britain, Advent already functions as a HealthBank.

Its cryogenic suites and HTA license make it both factory and vault under SI 87. For the U.K., the architecture is complete: tissue in, vaccine out, data constant.

The United States, however, separates the process.

21 CFR 1271 governs tissue establishments; 21 CFR 210/211 governs biologic manufacture.
To bridge them, a company must possess both—a legal and logistical duet.
That gap is the reason HealthBank U.S. was revived.

Re-filed and maintained by Linda Powers through USPTO filings in 2020, 2021, and 2024, HealthBank’s return created an American Human Cell and Tissue Establishment—a domestic gateway allowing U.S. tumors to enter the DCVax system without leaving FDA jurisdiction. Once cryopreserved under that license, a sample can travel to any compliant GMP node for vaccine manufacture. The tissue becomes a traceable export-class asset protected by U.S. law.

This single move solves multiple constraints:

1. Tariff immunity (announced policy). A domestic footprint protects against the proposed 100 % tariff on imported branded drugs unless U.S. production is under way.

2. Identity and serialization. Anchors each patient record inside the U.S. DSCSA system.

3. Comparability testing. Permits QC and label release on American soil.

4. Trial enablement. Eliminates import friction for adaptive or conditional-use studies.

Scale is secondary; registration and data symmetry are the keys.
Once HealthBank U.S. operates, every American sample can flow through the same digital backbone as its British twin.

Here WP50, Merck’s modular biologics complex in Pennsylvania, becomes the natural complement. Public planning documents describe it as a modern flexible facility for aseptic manufacture and fill-finish. Though not designed for DCVax, its modular and digital capabilities make it a plausible host site for compliant processes. WP50 can provide contract manufacturing or fill-finish capacity while HealthBank retains chain of identity and Advent retains process ownership. Merck’s engineers can participate without touching the regulatory core.

The organism now stands balanced:

•Advent (U.K.) – the metabolism, licensed factory and vault.
•HealthBank (U.S.) – the memory and intake, FDA-registered gate.
•WP50 (PA) – the modular muscle, capacity without control.

This separation allows multinational cooperation while safeguarding patient and intellectual ownership. It is collaboration without capture—a firewall made of law.

💰 The Economy of Continuity

Biology writes memory in molecules; economics writes it in ledgers.

HealthBank sits at their intersection.
Each cryovial it guards is both evidence and asset: a patient’s biological equity held in regulated trust.

The model monetizes readiness.
Patients pay for intake and storage; hospitals for validated kits; manufacturers for retrieval and testing; regulators and insurers benefit from real-time data that lower oversight cost.
The result is an economic loop where compliance itself becomes revenue.
Every stored cell is a subscription to future capability.

Advent earns through throughput.
HealthBank earns through custody.

Together they form an economic metabolism—a system where safety, quality, and margin rise together.

Unlike speculative biotech valuations, which hinge on binary approvals, this structure produces recurring income from the infrastructure that makes approvals possible.

When the Promising Pathway Act eventually matures, its demand for continuous evidence will amplify this effect. HealthBank’s identity ledger and Advent’s telemetry already supply the proof the law will require. Risk falls; valuation rises. In capital terms, HealthBank converts time into collateral.

In biological terms, it converts memory into immunity.

The announced tariff policy added a further incentive: only firms building or producing inside the U.S. avoid the duty. With HealthBank U.S. in place, Northwest Bio can operate across both jurisdictions in full legal harmony. Same digital language, different sovereignties—compliance doubled, exposure halved. This alignment makes cooperation with Merck, Regeneron, or Amgen possible without surrendering the immune instruction set.

The logic is elegant:

Advent proves that law can learn.
HealthBank proves that ownership can endure.
WP50 proves that precision can scale.
Together they transform regulation from restraint into intelligence.

HealthBank is more than a vault; it is the persistence layer of an evolving civilization.
For regulators it offers continuous visibility, for partners a compliant gateway, for patients a tangible share in their own biology.
For Northwest Biotherapeutics it offers permanence—a structure that earns, heals, and learns at once.

When the first patient signs consent and their tumor slides into a HealthBank cryovial, a signal will move through this network—Advent’s digital metabolism, WP50’s modular muscle, the reflex of adaptive law—and return to the body that started it.

That signal is not paperwork.
It is a civilization remembering how to heal.

📚 Sources

1. FDA 21 CFR 1271 – Human Cells, Tissues, and Cellular-Based Products.
2. MHRA & HTA licensure, Advent BioServices (2021–2025).
3. Emerson Automation Solutions: DeltaV & DeltaV-Mobile GMP systems.
4. Northwest Biotherapeutics press releases (2023–2025); Advent acquisition Aug 12 2025.
5. BioSpace (2010): “Specialized Bio-Bank Helps Lethal Brain Cancer Patient Defy Odds.”
6. U.K. Statutory Instrument 87 (SI 87) and ILAP.
7. Proposed U.S. Promising Pathway Act (2024–2025).
8. U.S. tariff policy on domestic biologic manufacturing (Federal Register, 2025).
9. Public planning records for Merck WP50 (Pennsylvania).
10. USPTO trademark database for HEALTHBANK serial numbers 90028672 (2020), 90755320 (2021), 98631412 (2024).

⚖️ Disclaimer

This essay synthesizes publicly available scientific, regulatory, and corporate information.
It is provided for educational and analytical purposes and does not constitute medical, legal, or investment advice.
All forward-looking statements are speculative and based on information current as of 2025.

[🇩🇰 The Danish Dude 🇬🇱 @FlemmingBruce]

$NWBO

NWBO + Advent: Hiring Into Launch Readiness (with three fresh signals)

What’s changed

• Advent is coming in-house. NWBO agreed (Aug 27) to acquire Advent BioServices for £1.4m plus net payables. At closing, ~19M NWBO securities previously issued to Advent (13.5M shares + 5.5M options) revert to NWBO; Advent’s fixed assets (incl. extensive cryostorage) and IP transfer as well. This is consolidation, cost take-out, and tighter CMC control in one move.

• Option-award lawsuit settled last week. NWBO reached a settlement that cancels 17% of the challenged 2020 options and brings $2.25M from insurers (court approval pending). Governance overhang reduced; dilution trimmed.

• HEALTHBANK filing. Per your USPTO screenshot, Linda Powers has a “HEALTHBANK” trademark application now assigned to an examiner (Oct 9, 2025)—a logical adjacency to DCVax’s supply chain (tumor tissue capture, storage, logistics).

Why the three new job ads matter

• Production Scientists (multiple) – Grade A/B/C operators for patient-batch manufacturing and closed-system steps; this is the talent you add when you expect more lots moving and when you’re preparing to cross over to automation.

• Cleanroom Technicians (multiple) – runners/EM/sterile transfers/CRF-LN₂ support; classic throughput backfill to increase cadence.

• Finance Team Lead – closes the loop on payroll, ledgers, audits, budgets; that’s the commercial plumbing you put in before revenue scale.

These hires line up with Advent’s formal CMC workstreams for the MAA—Comparability, Stability, Potency, Product Profile, MoA, Fill/Finish—already documented in company filings.

Facilities and capacity (clear + specific)

• Licensed footprint today: Advent/NWBO have 7 licensed cleanrooms (as shown in the industry slides you shared).

• Add-on build-out: Engineering is underway to deploy new Grade-C labs so Flaskworks EDEN (closed system) can run cheaper and at higher volume than Grade-B manual suites. This Grade-C expansion is in addition to the known seven rooms. Company disclosures also note 3M-vial GMP cryostorage and removal of some release-testing bottlenecks via partial automation and in-house QC.

• What’s already operating: Two Sawston suites support ~40–45 patients/month (~450–500/yr) under the current manual process—capacity that can be leaned on while Grade-C/EDEN is qualified.

Manual now, EDEN t

• Near term: Deliver using licensed manual Grade B/C suites—already staffed and releasing product under the MIA.

• Transition: GMP-grade EDEN units are being built; Advent will qualify/validate, run engineering lots, collect data, then apply for regulatory use. That opens Grade-C deployment once comparability is signed off. This is exactly how you de-risk a scale-up: bridge with manual, land on closed/automated.

Context for sentiment/FUD

• NWBO has publicly alleged spoofing/short-and-distort in court filings; an academic law-review case study details how these tactics can suppress biotech valuations and impede drug development, using NWBO as the example. That’s the noise investors are seeing on stock boards now.

Net take for investors

• Signals point to readiness, not distress. Advent coming in-house, option suit resolved on shareholder-friendly terms, HEALTHBANK IP groundwork, targeted hiring, MIA in hand, Grade-C build-out on top of the 7 rooms, growing cryostorage/QC capacity, and a defined EDEN automation path—this is a company positioning to execute as MHRA review winds down.

Bottom line: The postings match the last mile before scale. Constructive and significant for NWBO’s setup into approval and commercialization.

https://t.co/U7tHjuRTEX

[Spreadburn @Spreadburn]

@CleanLinksApp Super cool. Thanks a lot! 🙂

[Spreadburn @Spreadburn]

@CleanLinksApp would be cool if You could resolve Links from the Flipboard App, like this: https://t.co/hir32OApwM

[Hoffmann @hoffmann6383]

📢📢$NWBO Acquires Advent Bioservices

https://t.co/ud6uYmesP7

$NWBO acquires Advent for $1.4m‼️

What does this accomplish?

➡️Management Team Expansion

Headcount just went from ~20 (ish) $NWBO employees to likely 100+ total employees. As you will see from Linda Powers comment at the ASM, a goal was to expand the management team. This is certainly a step in the right direction as it gives $NWBO a much larger pool of employees to take on expanded roles. Image 1 shows Advent's headcount at the end of '23 being 73 employees.

Linda Powers at 2023 ASM, held June 29, 2024, stated, in relevant part:

"And very dear to our hearts, we need to expand the management team. We need to expand the management team rather substantially. As you probably have guessed, and as we described in the proxy, each of the core members of the senior team has been wearing multiple hats, has been fulfilling multiple roles. And I mean, multiple roles that would each be normally a separate senior management person at other companies. And I'm really proud that we've been able to do that, but we need to we need to ramp up. We we've got tremendous opportunity, and we need to ramp up. So that is going to be a significant focus for us, as soon as we can achieve it. We wanna be highly selective, but we plan to substantially expand the management team." [1]

➡️A revenue steam to potentially help obtain standard bank financing

I believe this puts $NWBO in a position to obtain standard bank financing based off of Advent's revenue stream. This should help slow future dilution. As you can see, Advent's financial statement (Image 1) shows about $27.5m USD in revenue for '23, which was a 23% increase over '22. [2] A more modest 15% growth rate would give them nearly $32m in revenue for '24. I believe this should allow $NWBO to be eligible for standard bank financing. Hats off to the late Les Goldman for getting us to this point by tirelessly raising funds from retail and institutional investors.

➡️What was the value of Advent?

Recall, Cognate BioServices, Inc. sold for $875m on projected revenue of $140m for the year, a 6.25 multiple of revenue (I know, I know, a really quick and sloppy way of looking at it). [3] Say Advent is up to $40m in revenue and using the same multiple it gives a value of $250m.

➡️Big Money more receptive to investments

$NWBO has largely survived on the backs of retail investors to date. To attract more institutional investors and even potentially a buyer, $NWBO needed to undo some entanglements and become more transparent. While the Advent/$NWBO related party relationship was legal, it created some complicated dynamics that could have scared off the bigger investors. With today's acquisition of Advent, $NWBO just became more attractive to deeper pockets, whether investing or acquiring. This was the first, and the biggest, domino that had to fall in this regard. Great first step.

➡️Another deceptive Adam Feuerstein narrative bites the dust

See Image 3.

Mr. Feuerstein needs to, at the very least, add another line (or two) to his graphic:

Shareholder money -> NWBO -> Advent -> Linda Powers [insert additions] -> NWBO -> Shareholders

[1]https://t.co/3wNfuUaROE

[2]https://t.co/jlZS4ceQTA"08717711_aa_2025-03-04.pdf"&X-Amz-Signature=42d084f11a9fd893890cea368d750d572ffe089449d946904fda5f66a33ee978

[3]https://t.co/Jb2l9TNvmy

[Spreadburn @Spreadburn]

@DrsfTock @scooterd_speaks @Kelly712717541 There are not many left on the open market (float)!

[Andrew Caravello, DO @andrewcaravello]

$NWBO 🎆 DCVax-L Access Unlocked: Fourth of July “Freedom to Treat” Edition

A Regulated Pathway to Personalized Immunotherapy—Now Active Under UK Law

A complete and accurate walkthrough of how recent changes in UK law quietly enabled preapproval access to DCVax-L under physician request, how tissue-in/vaccine-out access is now theoretically feasible under the Specials framework, and what steps remain before global delivery becomes a reproducible pathway.

⸻

1️⃣ NWBO Is Operational — Only Final Approval Remains

Northwest Biotherapeutics (NWBO) is no longer a purely developmental stage company. It is now positioned as an operational immunotherapy platform, pending only final commercial approval. Here is what is in place:

•Advent BioServices, NWBO’s UK-based GMP manufacturing partner, is known to be licensed to manufacture advanced therapies and has experience handling dendritic cell platforms. Pending public confirmation of Advent’s current Manufacturer’s Specials license scope for DCVax-L and any SI 87 Designation status.

•Flaskworks, NWBO’s closed system automation platform, supports consistent, scalable GMP-grade dendritic cell vaccine production. It aligns with regulatory expectations for decentralized or point-of-care systems described under SI 87.

•A Marketing Authorisation Application (MAA) was submitted to the UK MHRA in December 2023, currently under review.

•The company’s Phase 3 trial of DCVax-L in glioblastoma has been completed, peer-reviewed, and published in JAMA Oncology (2022), demonstrating robust long-term survival benefit.

•Most critically, a preapproval access pathway now exists under UK law, via the combined provisions of SI 87 and the UK Specials framework.

This framework does not require the MHRA to issue commercial marketing authorization in order for patients to begin receiving treatment if certain conditions are met.

⸻

2️⃣ The UK Law That Quietly Unlocked Preapproval Access: SI 2025 No. 87

On June 17, 2025, the UK implemented a new regulation:
Statutory Instrument 2025 No. 87
📎 https://t.co/noX6ho5MOO

Formally titled The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025, this law creates the first explicit legal framework in the UK for the decentralized manufacturing of personalized cell therapies, including dendritic cell vaccines like DCVax-L.

⸻

🧩 A. Legal Framework for Decentralized Manufacturing

SI 87 introduces a new Designation pathway, allowing manufacturers to operate:

•Modular or mobile GMP-compliant cleanrooms

•Closed system automated manufacturing platforms like Flaskworks

•Under the governance of a licensed central control site responsible for QA/QC and batch release

📎 MHRA Designation Step:
https://t.co/ThArIwb1Jr

The regulation formally enables decentralized ATMP production within a quality-assured network, opening the door to scalable, on-demand manufacture of patient-specific therapies.

⸻

🧩 B. Integration With the UK “Specials” Framework for Named Patient Access

The most important feature—and the one that enables near-term patient access—is that SI 87’s decentralized manufacturing model is now compatible with the UK “Specials” system.

The Specials framework under Regulation 167 of the Human Medicines Regulations allows:

•A licensed UK physician to request an unlicensed therapy for an individual patient

•A GMP-certified manufacturer to produce that therapy specifically for that patient

•The product to be paid for privately and administered outside of clinical trials or formal product licensing

📎 MHRA Specials Guidance:
https://t.co/SrQlwswhyx

Before SI 87, Specials requests were limited to traditional fixed-site GMP operations. Now, under SI 87:

•A manufacturer using decentralized or modular GMP infrastructure can fulfill Specials requests

•Provided they are Designated under SI 87 and the product is made under proper MHRA oversight

This regulatory alignment is what legally opens the door to manufacturing DCVax-L doses today under physician request—even before full commercial approval is granted.

⸻

🧩 C. Does This Mean Patients No Longer Need to Travel?

Before SI 87, patients accessing DCVax-L under the Specials route were generally required to travel to the UK because:

•The therapy had to be administered in-country by a UK physician

•Manufacturing and delivery pathways were tied to centralized UK-based logistics

SI 87 now makes it legally feasible for a physician to order a dose, have it manufactured at a designated UK facility, and arrange delivery back to the requesting clinician or treatment site.

That means:

•Tumor tissue or leukapheresed cells can be legally exported to the UK if the sending country allows it

•DCVax-L can be manufactured under GMP via SI 87-compliant systems

•Return shipment of the finished product is plausible, but not explicitly covered in the legislation

📎 FDA Personal Importation Policy:
https://t.co/GG9EB6W5EO

Important caveat:

Neither SI 87 nor the UK Specials guidance explicitly addresses the export of the final unlicensed product outside the UK. This does not necessarily prohibit it, but it means any such shipment must comply with:

•UK export regulations, including possible MHRA or Home Office approvals for ATMPs or CBPMs

•The import country’s rules, such as the US FDA’s personal importation policy or expanded access frameworks

So while SI 87 enables manufacturing without requiring the patient to travel, whether the product can be shipped back and administered outside the UK depends on both:

•The legal ability of UK manufacturers like Advent to export the finished ATMP

•The regulatory discretion of the receiving country, such as US physician and FDA import policy

⸻

📦 UK Export of DCVax-L — Legal Summary

The export of unlicensed advanced therapy medicinal products (ATMPs) like DCVax-L from the United Kingdom is legally permitted under existing UK law, provided specific regulatory requirements are met:

➡️ MHRA Manufacturer’s Licence

•Must be manufactured at a site with a valid MHRA MIA
•Advent BioServices holds this licence

➡️ MHRA Export Certificate
•Required: Certificate of a Pharmaceutical Product (Unlicensed) or Certificate of Manufacturing Status
📎 https://t.co/y9724EuCoB

➡️ HMRC Customs Declaration
•Exporter must file complete customs documentation
📎 https://t.co/sulURskrfH

➡️ Home Office or ECJU Licence (If Applicable)
•Required for controlled components
📎 https://t.co/y9724EuCoB

5️⃣ Compliance with GDP
•Shipment must comply with MHRA-enforced GDP standards
📎 https://t.co/jfvcN9AiK6

✅ Conclusion:
Yes, export is legally allowed if all conditions above are met. The UK provides a clear legal framework to authorize and oversee the export of unlicensed ATMPs like DCVax-L.

⸻

3️⃣ The Access Pathway Now Looks Like This

1.A physician initiates a request under the UK Specials framework
2.Patient’s tissue is collected and cryopreserved
3.Tissue is shipped to Advent BioServices in the UK
4.DCVax-L is manufactured under GMP using Flaskworks
5.If permitted, vaccine is shipped to the treating physician and administered abroad

This system is feasible under UK law. International delivery depends on cooperation from both exporting and importing jurisdictions.

⸻

4️⃣ Can US Patients Legally Participate?

Yes, provided the following:

•US law permits export of biospecimens
•Certified cold-chain couriers are used (Cryoport, Marken, World Courier)
•US physician oversight, informed consent, and proper documentation are in place

Import of the vaccine is governed by:

•FDA’s personal importation policy (discretionary)
•Expanded Access or Right to Try (requires coordination with the FDA)

So participation is possible—but not guaranteed.

⸻

5️⃣ Final Takeaway

•DCVax-L is legally accessible today in the UK under the Specials framework
•SI 87 enables decentralized GMP manufacturing
•Advent BioServices is ready to manufacture
•Tissue-in/vaccine-out is now viable—pending import cooperation
•UK export is allowed under clearly defined conditions

Access has begun. Approval is no longer the barrier.
This is the moment where potential became delivery.

📍 And to @DonDonjarvis101
Veteran of the 101st Airborne Division in Vietnam—thank you for your service 🇺🇸🫡

[Spreadburn @Spreadburn]

@adamfeuerstein @andrewcaravello @CohenMilstein @AndrewEcker829 Stop harassing medical experts. Are you an investigator now? You can contact him by just pressing the comment button if you have to say anything with value.

[Andrew Caravello, DO @andrewcaravello]

$NWBO 🧠 They Just Discovered What DCVax Already Fixed

A new Nature paper just announced something they think is groundbreaking: dendritic cells (DCs) the immune system’s scouts, can’t move inside tumors.

According to the researchers, as cancers grow, the tumor microenvironment shuts down nitric oxide, which shuts down soluble guanylyl cyclase, which shuts down cGMP, which shuts down myosin-II, the little molecular engine DCs use to crawl. With that system offline, dendritic cells can’t get from the tumor to the lymph nodes to alert the T cells. And if the T cells don’t get the message, the immune system doesn’t show up.

Immune collapse by traffic jam.

Their fix?

Sildenafil.

Yes, that sildenafil.

Better known by its street name: Viagra.

It turns out, if you pop a PDE5 inhibitor, you can restore cGMP, re-activate DC motility, and re-light the immune fire. In mouse models, this brings DCs back online and gets the immune system rolling again.

Clever biology. Bold move. Exciting headline.

But here’s the quiet part:

DCVax already fixed this. Years ago. And it didn’t need a prescription.

🧬 DCVax-L: Bypass the Battlefield

DCVax-L doesn’t even engage with the paralyzed, tumor-trapped dendritic cells the Nature paper’s trying to save. Instead, it replaces them altogether.

How?

It takes monocytes from the patient’s blood.

Grows them into healthy, antigen-loaded DCs in a clean lab.

Matures them with surgical precision.

And injects them into the skin, far from the toxic TME.

These DCs then migrate to the lymph nodes like any healthy immune cell would and get straight to work. No suppression. No detour. No Viagra.

DCVax-L doesn’t hack the system. It sidesteps the failure entirely.

⚔️ DCVax-Direct: Right Into the Fire, And Still Marching

Now DCVax-Direct is a different beast.

It goes directly into the tumor, right into the environment the Nature paper says is hostile to DC movement. If there’s ever a test case for whether DCs can function under pressure, this is it.

But according to Dr. Marnix Bosch’s June 2025 NYAS presentation, DCVax-Direct doesn’t just survive there.

It thrives.

In over half of patients, DCVax-Direct triggered CD4+ and CD8+ infiltration in just 7 days .

It caused systemic immune activation, with matching T cell clones in blood and tumor .

It shrunk distant tumors after injecting just one lesion, the abscopal effect in action.

And it did this in patients who had failed everything else.

And here’s the kicker: these responses directly correlated with TNFα and IL-12, two key cytokines that regulate DC migration and T cell priming. Exactly the signaling axis the Nature paper says is broken.

So what they were trying to patch with PDE5 inhibitors?
Bosch’s DCs were already doing it, in humans, under real-world conditions.

⚙️ Supercharging with Boosters: No Blue Pill Needed

Bosch also unveiled next-gen DC enhancement:

Booster cocktails that turbocharge cytokine output, including TNFα, IL-12p70, IFNγ, CXCL9, CCL2, GM-CSF, and more .

These agents can convert low producers into high responders and expand immune reach .

They even upregulate migratory and chemotactic molecules, so the DCs don’t just survive in the tumor… they move, they signal, and they lead .

It’s a masterclass in pre-programming.
While other therapies hope the immune system wakes up, DCVax-Direct shows up with cells that are:
Locked.
Loaded.

And looking for lymph.

💊 Who Needs the Little Blue Pill Now?

Checkpoint inhibitors? They assume DCs are functioning.
In situ vaccines? Same problem.
Most cancer immunotherapies? Still depend on the very endogenous DCs that this paper proves are asleep at the wheel.

So yeah, maybe they need a boost.

But DCVax-L?

It delivers the message directly to the command center.
And DCVax-Direct?

It parachutes into enemy territory, sets up a cytokine outpost, mobilizes the troops, and radios for air support.

All without needing pharmacological encouragement.

🎯 The Final Word, And the Fun One

Let’s not dance around it.

Other cancer immunotherapies might need Viagra just to get their dendritic cells to show up.

Meanwhile:
DCVax-L is already at the lymph node giving the briefing.

DCVax-Direct is already lighting fires in tumors and calling in T cell reinforcements.

So if you’re wondering who really needs the little blue pill…

It’s not DCVax. DCVax is the blue pill.

“Ask your doctor if your immune system is ready.

Side effects may include sudden immune competence, distant tumor shrinkage, long-term survival, and unexpected investor confidence.
If tumor regression lasts more than four years, please alert the media.”

📄 Nature Study: Rescuing dendritic cell interstitial motility: https://t.co/zdCesWmZ9Q

📊 Bosch NYAS 2025: DCVax-Direct triggers cytokine-driven DC migration, T cell priming, and systemic responses, in real patients https://t.co/8MgNXfEc3C

$IBRX $IMTX $MRK $PFE $BMY $REGN $VRTX $CTMX $SANA $IOVA $GILD $AZN $JNJ $NVS $AMGN $SNY $LLY $AMZN

#DCVax #Immunotherapy #CancerImmunotherapy #DendriticCells #DCVaxL #DCVaxDirect #TumorMicroenvironment #TME #BiotechStocks #BiotechInvesting #Oncology #CancerVaccine #PersonalizedMedicine #CheckpointInhibitors #MHRA #NIH #NYAS #GBM #Glioblastoma #CancerTreatment #CDMO #Cytokines #AdaptiveImmunity #CancerImmunityCycle #ProjectOrbis

[Spreadburn @Spreadburn]

@DocOck222 @ATLnsider Absolutely not