autologous assassin 🇺🇸🇨🇦🇺🇦🇮🇱

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! prnewswire.com/news-releases/…

🔥 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.

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

@flaskworks @6brooks @rrao111 I did a conversion yesterday and this is exactly what Fidelity told me. And, OMG, Grok was incredible guiding me through the process and giving me multiple scenarios for handling the taxes on the “in kind” transfer. Thanks for the recommendation!

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.

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! x.com/ATLnsider/stat… youtu.be/rBeNQBoPyfk?si…

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.

Wow, $NWBO's FINRA short volume ratio was nearly 75% yesterday. This makes me so bullish: nobody sane would open a new short position as the risk is off the charts, so it's existing shorts digging themselves deeper out of pure desperation. We're close now, friends!

@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.

@MDendream I’m sure you know, with all your experience, what happens in a CL2 lab for example. Would you want one of those in the same building as multiple clean rooms for manufacturing? Then think about what got treated in the Specials Program and what might have interested the MHRA

$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.

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: investorshub.advfn.com/boards/read_ms…

Excellent interview with @mcuban youtu.be/di3AqpoLI74?si…

$NWBO True, true. Let’s look deeper into this 👇🏻

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. investorshub.advfn.com/boards/read_ms…

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.

Thanks to @flaskworks for having "gotten" to the bottom of this 👋

$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?

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.

@flaskworks While I'm in great appreciation of the huge amount of dd regularly shared regarding the potential upcoming approval of #dcvax, I'm not exactly sure if reaching out to MRHA w/ inquiries is productive. There's reasons it taking this long, let's give MRHA the space to do their work.

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.

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.

@rrao111 @flaskworks I respectfully disagree with your statement regarding how Roth conversions are taxed.

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. x.com/flaskworks/sta…

@flaskworks Again, I don't care to argue about the merits of AI. It can be a fine tool. In this specific case it output something clearly false. You seem to be wanting to get into a pissing match about AI and not address the inaccurate information I've pointed out. My last response here 😀

@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.

I'm fine with AI. Yet, you can't blindly accept everything from AI as factual. You need to double check. I just linked you something that was clearly not factual in that AI statement. Instead of addressing the underlying factual (or non-factual) basis of your post, you deflected and made it seem like I was anti AI. I don't care to get into some pissing contest on the merits of AI. I'm fine with AI so long as you double check what is spit out.

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.

@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.

@hoffmann6383 Yes and he's wrong x.com/flaskworks/sta…

I don't think that happens until later. I been saying for a while that $NWBO's Flaskworks will require a variation to the MAA being filed. Lykiri is making the same assertions and he cites to some rules (assuming EMA/MHRA are similar, and I believe they are): "EDEN/Flaskworks is a new production method, and this would be considered a "change in the manufacturing process." According to EMA guidelines, which have largely been adopted by the MHRA, such changes cannot be implemented during the approval procedure and must be submitted as a variation after approval. “Once the application is validated, it is normally not permitted to add a new site or to change the steps of manufacture/release described in the dossier during the 210-day assessment procedure. Any additional site or change in the manufacturing or batch release arrangements should be submitted as a variation after the granting of the marketing authorisation."" (emphasis added) [1] [1]investorshub.advfn.com/boards/read_ms…