autologous assassin 🇺🇸🇨🇦🇺🇦🇮🇱

Retail $NWBO shareholder. Posts my own opinion. Make your own decisions. Not legal, investment, medical, or economic advice.

[autologous assassin 🇺🇸🇨🇦🇺🇦🇮🇱 @flaskworks]

Some investors misunderstood $NWBO Feb 6, 2024 PR.

The “engineering runs” on GMP-grade Flaskworks units are for commercial deployment not regulatory comparability.

Comparability was already completed using functionally equivalent prototype units.

Adjusting size of unit, fit, power supply, color, buttons, etc for mass production does not invalidate comparability assays.

Per ICH Q5E, regulators require:

🎯 Same purity, identity, biologic profile, & yield

🎯 Validated release assays under GMP-compliant conditions

🎯 No new clinical data if assays are comprehensive

If that data was submitted before MHRA validated the MAA (Jan 24, 2024) then Flaskworks was already under review when units for mass production were ordered then later proven to be at GMP standards.

Subsequent engineering runs are standard IQ/OQ/PQ steps to ensure the final GMP units work as expected but they are not for redoing comparability. So they do not need to be completed before Flaskworks data was included in MAA. They are a final validation step prior to GMP approval.

These engineering runs ensure:

🔥 IQ – Installed correctly

🔥 OQ – Operates as intended

🔥 PQ – Performs the process consistently with real materials

In short:

✅ Comparability already accepted
✅ Validation runs were for scale-up
✅ Approval isn’t waiting on hardware
✅ Feb 2025 GMP license update = validation runs successful = Flaskworks GMP process approved!

https://t.co/82ui1ktVe1

[autologous assassin 🇺🇸🇨🇦🇺🇦🇮🇱 @flaskworks]

🔥 Woods Adopted R&R in Full 🔥

Woods adopting the R&R in full changes nothing for $NWBO long term.

Why?

Because @CohenMilstein will appeal.

Stein violated clear 2nd Circuit precedent by introducing external sources at the MTD stage to discredit long-term price impact which is a blatant violation of Rule 12(b)(6).

🧵 Let’s be clear:

1️⃣ This wasn’t summary judgment.

2️⃣ The SAC allegations must be taken as true.

3️⃣ External studies were improperly used to resolve factual disputes—strictly prohibited.

4️⃣ 2nd Circuit has ruled AGAINST this repeatedly:

✅Goel v. Bunge (2016)

✅Global Network v. NYC (2006)

✅ Kramer v. Time Warner (1991)

💥 This is textbook reversible error.

Woods just handed @CohenMilstein an easy appeal.

The fight isn't over as it's now moving to the 2nd Circuit where binding precedent favors $NWBO.

You can delay discovery but you can't bury the truth.

[autologous assassin 🇺🇸🇨🇦🇺🇦🇮🇱 @flaskworks]

@AngstromU @6brooks @rrao111 I converted mine when the stock was around 60 cents :)

[autologous assassin 🇺🇸🇨🇦🇺🇦🇮🇱 @flaskworks]

If you own $NWBO in a Traditional IRA then now is the perfect time to consider a Roth IRA conversion.

Why?

🧠 Pay taxes on $0.22/share now

🧠 All future gains grow tax-free

🧠 No RMDs, great for estate planning

🚀 When NWBO hits $10 that’s $1M tax-free on 100K shares

Not financial advice. Consult a tax professional.

[autologous assassin 🇺🇸🇨🇦🇺🇦🇮🇱 @flaskworks]

Fundamentals always win. $NWBO no exception.

For context Keytruda treated ~120K – 200K patients in 2024 based on ~$30B in revenue at $150K – $250K per patient.

Sawston has cold storage for 3M doses or ~300K patients.

The scale is real. The science is real. The upside is absurd!

https://t.co/gPjNbzeJPJ

https://t.co/ffRkJY2FCb

[ATLnsider @ATLnsider]

I had a chance to update my $NWBO share price valuation table, after #DCVax-L is approved in the UK, then eventually in the US, Canada, Germany and the rest of the EU & around the world. Then, tissue agnostic approvals for all or most solid tumor cancers. Some investors are concerned about current share price manipulation & the forced dilution to fund the company & to pay bills. But my focus is on future milestones & future regulatory approvals: https://t.co/5UTYcJ3aHJ

[autologous assassin 🇺🇸🇨🇦🇺🇦🇮🇱 @flaskworks]

75% short volume doesn’t mean tons of people are betting $NWBO 📉.

It usually means market makers are shorting (borrowing from others) to fill buy orders because they don’t have enough shares to fulfill their mandated role as liquidity providers.

They could also be shorting to fulfill buy orders for a client who wants a low price for entry.

That pressure means when news hits we could gap up violently because our float isn't liquid enough for large institutional buyers.

Market makers which borrowed to fill buy orders must return them and it will be after news when everyone demands a much higher price.

[autologous assassin 🇺🇸🇨🇦🇺🇦🇮🇱 @flaskworks]

@metacollectiveG He's been going around with FeMike looking to file a class action lawsuit against management for over a year.

These "shareholders" should be blocked and ignored since they, like most town cranks on a soapbox, only thrive when given attention.

[Gregory Zivic, MD @metacollectiveG]

$NWBO Please keep in mind that the last time there was a “delay” in MHRA approval it was for the first MIA. The reason was they were able to add worldwide distribution to the approval. Thinking creatively in a silent space might give you some peace of mind if you look carefully.

[ATLnsider @ATLnsider]

You can read my post $NWBO #DCVax-L below, research shows there’re about 3,000 nGBM patients & 1,500 rGBM patients per year in UK. That’s a total of 4,500 GBM patients / Year in UK. At a cost of $200,000 per patient, the initial market in UK just for GBM is $900 million per year: https://t.co/VeVvMdhCFe

[autologous assassin 🇺🇸🇨🇦🇺🇦🇮🇱 @flaskworks]

Excellent interview with @mcuban

https://t.co/kz4pKN2rpg

[🇩🇰 The Danish Dude 🇬🇱 @FlemmingBruce]

$NWBO

True, true.

Let’s look deeper into this 👇🏻

[autologous assassin 🇺🇸🇨🇦🇺🇦🇮🇱 @flaskworks]

Lykiri's interpretation of $NWBO and Flaskworks is incorrect and built on a misreading of EMA commercial manufacturing rules that don’t apply to NWBO’s case for three reasons:

1. He’s Quoting EMA Centralized Procedure Rules—Not MHRA’s ATMP Pathway

The quote about “not permitted to add a new site or change steps of manufacture after validation” applies to non-ATMP central submissions to EMA—not to the MHRA’s national MAA for an ATMP, where rolling, parallel comparability updates are explicitly allowed under:

✅️ ICH Q5E – Which governs comparability for biologics

✅️.EU GMP Annex 15 – Which permits validation runs during submission

✅️ MHRA ATMP Guidelines – Which allow inclusion of non-finalized data if comparability is demonstrated and commitments are in place

NWBO clearly followed this path.

2. NWBO Confirmed Comparability Pre-Validation

On Feb 6, 2024, NWBO stated that Flaskworks-produced DCVax-L met the same:

✅️ Purity

✅️ Biologic profile

✅️ Dose yield via validated release assays (language that only applies to GMP conditions).

🧠 That means Flaskworks comparability was demonstrated before the Jan 24, 2024 MAA validation cutoff—as required.

And on March 7, 2024, NWBO confirmed MHRA had validated the MAA, meaning all required data was accepted. Under MHRA rules:

“All required information must be included for the application to be considered valid.”

If Flaskworks wasn’t included, the MAA would have been kicked back as incomplete.

3. GMP Update Confirms Flaskworks Inclusion, Not Post-Approval Variation

On Feb 21, 2025, MHRA updated NWBO’s GMP certificate to include commercial-grade Flaskworks.

MHRA does not update a GMP license unless:

✅️ The process was part of the MAA submission

OR

✅️ A Type II variation was filed post-approval

No such variation was ever disclosed or filed, meaning Flaskworks had to be already under review.

This matches Linda Powers’ own ASM remarks: Flaskworks validation was happening “in parallel” with the MAA—not after it.

Conclusion:

EMA commercial manufacturing rules don’t apply here

Flaskworks was reviewed under ATMP-specific MHRA pathways

Comparability was proven before MAA validation

Final validation was for scale-up, not re-proving comparability

GMP license update confirms Flaskworks was included all along

The theory that Flaskworks is a post-approval add-on is flat-out wrong. MHRA policy, the company’s PRs, and the updated license all point to one conclusion:

🚀 Flaskworks EDEN was part of the MAA from the start.

Don’t conflate general EMA guidance with the specific rules that govern GMP process changes in ATMPs under ICH Q5E and Annex 15.

https://t.co/ZV7lkoCpVW

[autologous assassin 🇺🇸🇨🇦🇺🇦🇮🇱 @flaskworks]

Together we see an irrefutable regulatory proof package regarding $NWBO and Flaskworks:

🔥 Comparability was shown with validated GMP-grade assays.

🔥 The system was GMP-compliant before MAA validation.

🔥 Flaskworks was included in the MAA or MHRA validation would have failed.

🔥 The Feb 2025 GMP license update confirms Flaskworks passed final PQ testing.

🔥 Regulatory logic (ICH Q5E + Annex 15) supports concurrent review of manufacturing changes when comparability is demonstrated and commitments are in place.

Reality check:

This is a textbook execution of regulatory compliance and rolling submission strategy for ATMPs.

[🇩🇰 The Danish Dude 🇬🇱 @FlemmingBruce]

$NWBO

I have made several AI's concurrently look into all SEC filings, PR's, ASMs and all criticism today on Investorshub into this thesis, and correlating their answers between them:

Was Flaskworks EDEN
included in the
MAA for DCVax-L?

In short?

[autologous assassin 🇺🇸🇨🇦🇺🇦🇮🇱 @flaskworks]

The fact that approval's taking so long suggests it will have monumental impact as is the case with novel best in class therapies. However at the same time patients are suffering while MHRA has known about DCVax for more than a decade. So I find it ethically correct to ask them to expedite approval. I am not fishing for material non public information.

[autologous assassin 🇺🇸🇨🇦🇺🇦🇮🇱 @flaskworks]

Some investors misunderstood MHRA’s email to $NWBO shareholders:

“We cannot share information regarding an application without the company’s agreement.”

This does not mean the MAA was approved and the company is “sitting on it.”

That language is standard protocol to avoid:

💩 Selective disclosure

💩 Violating Reg FD (Fair Disclosure)

💩.Insider trading liability

If DCVax-L were approved:

🔥 NWBO would be legally required to disclose via 8-K within 4 days

🔥 A press release would follow immediately

👮‍♂️Holding back would be an SEC violation with major consequences

MHRA’s wording simply reflects that they can’t speak for the sponsor, not that approval has secretly occurred.

This is normal during label review or final decision prep.

[Peter Davis @peter_brit]

#dcvax $nwbo #gbm

Interesting that MHRA added the following additional comment to similar comments they made when replying to others recently:-

"As a regulator, unless we have the company’s agreement, we cannot share information regarding an application. We appreciate you may be a Shareholder, but we cannot give out information without company permission"

Red_Right_Hand
33 minutes ago
Post #756,289
Re: #756,286: @pgsd - Did that also have the same emphasis on

From muee88 on February 4th.

muee88
Tuesday, February 04, 2025
Post# of 747454

Recent response from the MHRA regarding the status of the DCVax application:

“We understand and support the need for treatments for glioblastomas and are actively working to ensure all medicines filed are safe, effective, and manufactured with appropriate quality standards, and subsequently reach patients as rapidly as possible.

In our role we are responsible for licensing medicines and ensuring that both medicines and medical devices work and are acceptably safe.

As you have already seen, the company has announced that they have submitted their application to us. We are working actively on this application, recognising the impact this medicine could potentially have.

[insert a bunch of link for contacting NWBO]

Finally, please be assured we a progressing this application as rapidly as possible and in collaboration with the company.”

https://t.co/dEdJSOLBpm

https://t.co/msUNtnHo7V

[autologous assassin 🇺🇸🇨🇦🇺🇦🇮🇱 @flaskworks]

He's wrong as you pay taxes on the current market value of the assets at the time of conversion not what you originally contributed. Doesn’t matter what you paid for $NWBO, the IRS taxes you on what it’s worth today. Fidelity, Schwab, IRS Pub 590-B all confirm this fact. He might want to double-check with a real tax advisor. I know because I did this already.

[autologous assassin 🇺🇸🇨🇦🇺🇦🇮🇱 @flaskworks]

The Feb 6, 2024 PR from $NWBO made it clear:

Flaskworks had already produced DCVax-L that was “substantially comparable” to the manual method—confirmed via validated release assays.

That’s the core requirement under ICH Q5E for establishing comparability.

Yes, the PR also says GMP-grade units were being built for final validation but that’s about scaling manufacturing not proving comparability.

So let’s be clear:

✅ Prototype Flaskworks = biosimilar product confirmed
✅ Assays were validated = GMP-grade testing environment
✅ Final GMP units = IQ/OQ/PQ for full deployment
✅ Feb 2025 GMP license update = MHRA signed off on GMP units

This isn’t “AI fantasy" or "AI hallucination."

It’s just understanding regulatory sequencing.

Dismiss the tech all you want but don’t dismiss the facts.

https://t.co/cQgq1kYMgW

[autologous assassin 🇺🇸🇨🇦🇺🇦🇮🇱 @flaskworks]

Flaskworks didn’t need mass-produced GMP units to be included in the $NWBO MAA.

Per ICH Q5E (used by MHRA):

"A demonstration of comparability does not necessarily require clinical studies if analytical & functional tests are sufficiently comprehensive."

NWBO's Feb 6, 2024 PR confirmed Flaskworks-produced DCVax-L met those criteria:

✅️ Same purity
✅️ Same biologic profile
✅️ Same yield
✅️ Validated via regulatory-grade release assays

That’s all MHRA needs to review a process change within the MAA—not full commercial rollout.

Flaskworks comparability could’ve been submitted in Jan 2024, before MHRA validated the MAA on Jan 24.

The Feb 2025 GMP license update shows MHRA approved a new process because licenses don’t change unless the process does as well.

Regulators don’t approve machines. They approve processes.

If a prototype runs the final validated process, and the product meets ICH Q5E comparability standards, then that’s sufficient.

Flaskworks proved comparability via release assays, not marketing brochures.
MHRA cares about product quality, which NWBO proved, not whether the machine says “prototype.”

This is textbook Q5E compliance.

Dismiss the noise, follow the data, and most importantly trust the GMP process change!

[autologous assassin 🇺🇸🇨🇦🇺🇦🇮🇱 @flaskworks]

@hoffmann6383 “Garbage in, garbage out” only applies if the input is garbage. But when you feed AI actual regulatory documents, $NWBO peer-reviewed science, validated press releases, and ICH/MHRA policy, you don’t get garbage. You get precision.

What matters is the source not the tool.

[autologous assassin 🇺🇸🇨🇦🇺🇦🇮🇱 @flaskworks]

AI didn’t misunderstand LP’s ASM remark rather the IHub poster's interpretation lacks regulatory nuance on $NWBO.

LP said validation runs would generate additional comparability data, not that comparability hadn’t been shown.

Big difference.

The Feb 6, 2024 PR confirmed Flaskworks-produced DCVax-L had the same purity, biologic profile, and dose yield based on validated release assays.

That’s precisely what ICH Q5E requires to demonstrate comparability.

Per MHRA policy, initial comparability + a commitment to complete GMP validation (IQ/OQ/PQ) is sufficient to include a new process in the MAA.

That validation was clearly successful as GMP license updated Feb 20, 2025.

MHRA doesn’t amend a license without approving a new process.

Amendment of GMP license isn't initiated by the regulator but applicant.

In short:

✅ Comparability proven pre-validation
✅ Validation runs = final step for GMP license
✅ License update = Flaskworks approved

What you're calling a contradiction is actually how ATMP submissions work.

This isn’t AI vs humans.

It’s regulatory literacy vs armchair confusion.

[autologous assassin 🇺🇸🇨🇦🇺🇦🇮🇱 @flaskworks]

@hoffmann6383 Every Institutional Investor on the street uses AI.

Every Hedge Fund. Every HFT firm.

If you prefer to do $NWBO research with the Dewey Decimal System then by all means proceed.

I value having a team of analysts improving my gains because that's what matters.

[autologous assassin 🇺🇸🇨🇦🇺🇦🇮🇱 @flaskworks]

@hoffmann6383 Yes and he's wrong

https://t.co/09TjFmkODE

[autologous assassin 🇺🇸🇨🇦🇺🇦🇮🇱 @flaskworks]

Some investors misunderstood $NWBO Feb 6, 2024 PR.

The “engineering runs” on GMP-grade Flaskworks units are for commercial deployment not regulatory comparability.

Comparability was already completed using functionally equivalent prototype units.

Adjusting size of unit, fit, power supply, color, buttons, etc for mass production does not invalidate comparability assays.

Per ICH Q5E, regulators require:

🎯 Same purity, identity, biologic profile, & yield

🎯 Validated release assays under GMP-compliant conditions

🎯 No new clinical data if assays are comprehensive

If that data was submitted before MHRA validated the MAA (Jan 24, 2024) then Flaskworks was already under review when units for mass production were ordered then later proven to be at GMP standards.

Subsequent engineering runs are standard IQ/OQ/PQ steps to ensure the final GMP units work as expected but they are not for redoing comparability. So they do not need to be completed before Flaskworks data was included in MAA. They are a final validation step prior to GMP approval.

These engineering runs ensure:

🔥 IQ – Installed correctly

🔥 OQ – Operates as intended

🔥 PQ – Performs the process consistently with real materials

In short:

✅ Comparability already accepted
✅ Validation runs were for scale-up
✅ Approval isn’t waiting on hardware
✅ Feb 2025 GMP license update = validation runs successful = Flaskworks GMP process approved!

https://t.co/82ui1ktVe1