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Baxers $nwbo @alphavestcap Re: Baxers post# 818498 Saturday, March 21, 2026 4:00:11 PM One more little thing to bolster the case for an announcement by/ before end April/ early May. Something I just noticed that had alluded me before: In my original post I discussed mRESVIA, Moderna's mRNA therapy for Lower respiratory tract disease (LRTD), which I believe is the most similar treatment to DCVax amongst all other assessments that have followed the National Procedures pathway and which received a full MA 71 days after it's last CHM meeting. mRESVIA however had 3 CHM meetings, 200 days apart, 83 days apart and then 71 days until approval. What I hadn't noticed during my original review is the time it took mRESVIA to go from CHM 2 to the Approval announcement (83 + 71) is also 154 Days. The exact same length of time that it took Aucatzyl to go from it's 2nd CHM to the Announcement! I do not believe that this is a coincidence. In both cases I reckon this likely represents the maximum aggregate length of time after the 2nd CHM (Clock-On Day ~150) that the MHRA (+60 clock-on days) and Sponsor (+90 clock-off days) are allowed to respectively use (plus a stop/start buffer time allowance of ~4 days) in order to remain within the statutory clock-on limits of the HMR 2012 Schedule 11 framework - regardless of whether or not there needs to be a 3rd CHM meeting! We know from published minutes that DCVax didn't get discussed at the January 29/30th CHM. But it could have been discussed again at the February 26/27th CHM (which would be similar to mRESVIA's 83 day gap vs a potential 91 day gap for DCVax if it was discussed - the difference in which comes entirely down to the pre-planned CHM meeting dates). Based on the MHRA publishing schedule we wont know if DCVax was discussed a 3rd time until mid to late April as it takes 6-8 weeks. Nevertheless, whether DCVax is following a 2 or 3 CHM meeting schedule, I believe that the end result (if the maximum 210 Day statutory clock-on limit is used) will still be around the same time, end April/ beginning of May. See new posts Conversation alphavestcapital.com@alphavestcapBaxers Tuesday, April 14, 2026 5:30:27 PM Yep, today is the 137th day since CHM #2 No sign of the minutes from the February 26/27th CHM meeting yet, but I expect them published before the end of the month which will tell us if a 3rd CHM was required. Whether a 3rd CHM was needed or not, my expectation is still ~154 days from CHM #2. That happens to land us on a Friday May 1st. I sincerely doubt MHRA or the company will release news on a Friday and likely not a Monday either so my take for an MA announcement is either 4th/ 5th May. That is also 4-5 days past the forthcoming MHRA regulatory update day (with possible publication of the guidance on use of RWD in ECT) so the timing makes sense. 🤞$nwbo@alphavestcap

$NWBO @alphavestcap QUESTION TO CLAUDE ANTHROPIC AI: northwest biotherapeutics (nwbo) filed its maa application for its dendritic cell cancer vaccine immunotherapy (dc vax L) with the mhra in december 2023.mhra timeline guidence states that approvals occur on average within 210 days.Why is the mhra still processing the dc vax l application 850 days after the maa was filed in december 2023? ANSWER: "This is a genuinely complex regulatory situation. Let me give you a structured, honest answer based on what is actually documented versus what is speculative. The 210-Day Baseline Is Not the Whole Story The MHRA's 210-day target is measured in "regulatory clock days" — meaning it explicitly excludes "clock-stops." If an applicant receives a Request for Further Information (RFI) during the review, the clock is paused. Applicants must respond to all RFI questions within 6 months, and the review timeline resumes only after the response is received. GOV.UK So the 210-day clock and the calendar are two very different things. For a complex, first-of-its-kind personalized immunotherapy, multiple clock-stops are the rule, not the exception. NWBO itself anticipated this, stating at the time of submission that "the review process will be a period of intensive and extensive further work involving responding to questions and requests for further information by the regulatory authority as well as preparing for and undergoing detailed inspections of the contract research organizations, the Sponsor, the Trial Master File, a number of individual trial sites, the GMP facility and manufacturing information." Nwbio Documented Reasons for the Extended Timeline Several factors specific to DCVax-L are well-documented: Scientific complexity and novel trial design. DCVax-L used external matched controls rather than a traditional randomized placebo group. This unconventional methodology — however justified ethically — required additional regulatory scrutiny and likely multiple rounds of questions from the Commission on Human Medicines (CHM). The document provided here notes all science-related RFIs were satisfied only as of August 31, 2025. Multiple rounds of manufacturing inspections. DCVax-L is a highly unusual product: it is a personalized, patient-specific dendritic cell vaccine manufactured fresh for each individual. The MHRA had to inspect and certify the Sawston manufacturing facility, CROs, trial sites, and the entire chain of custody. According to the document you provided, the last Sawston GMP inspection was completed only around October–November 2025. Manufacturing licensure and the Advent/HTA issue. The document references a key stumbling block: the Human Tissue Authority (HTA) Tissue Procurement license for Advent BioServices, NWBO's UK manufacturing entity. This appears to have been a prerequisite that was only resolved in the months leading up to late 2025. The Flaskworks/Eden comparability question. NWBO introduced automated manufacturing (Flaskworks Eden system) during the review period. The MAA was validated by the MHRA on March 7, 2024, meaning the 150-day clock began then rather than at submission in December 2023. InvestorsHub Adding comparability data for a new manufacturing process mid-review almost certainly triggered additional clock-stops. CHM advisory process. The MHRA is responsible for ensuring that medicines meet standards of safety, quality, and efficacy, and the CHM (Commission on Human Medicines) is the independent scientific advisory body that must advise on the application before a final decision is issued. UK Parliament According to the document you provided, a second CHM meeting was held in November 2025. After a second CHM meeting, the MHRA then issues a final grant or refusal letter — a step that itself takes additional weeks. Where Things Stand as of April 2026 No public approval announcement has been made as of today's date. Based on the information in your document and public records: All science RFIs appear resolved (August 2025) Manufacturing inspections appear complete (October–November 2025) The CHM held a second meeting in late November 2025 and its notes, released December 29, 2025, appear to indicate a favorable posture — no "28-day letter" suggesting major deficiencies was issued The 10-K filing has been delayed (NT 10-K filed March 31, 2026) and the community expects it imminently, with possible concurrent deal or approval news The investor community has been predicting approval as "imminent" repeatedly since early 2025, and those predictions have not yet materialized — which is a useful reminder that even when the regulatory tea leaves look favorable, the actual grant letter timing is opaque and entirely within the MHRA's discretion. The Honest Bottom Line The 850-day duration reflects a combination of legitimate regulatory factors: multiple clock-stops for RFIs, a novel and complex trial design, extensive multi-site manufacturing inspections, mid-review manufacturing changes requiring comparability data, and the multi-step CHM advisory process. None of these individually are unusual for a genuinely novel first-in-class personalized immunotherapy. The combination of all of them, however, has produced an unusually long calendar timeline. As of today, a formal approval decision has still not been publicly announced ."

$nwbo @alphavestcap x.com/alphavestcap/s… x.com/d_stock07734/s… x.com/alphavestcap/s…

$nwbo @alphavestcap x.com/HarryAine1/sta… applications for NWBO:Mining the dataset for predictive biomarkers (e.g., who are the long-tail responders? MGMT/IDH status correlations already noted). Optimizing combos (e.g., with checkpoint inhibitors or the new αDC1/TME-reprogramming tech from Roswell Park). Enhancing Flaskworks automation/next-gen DC manufacturing via AI-driven process analytics. Real-world post-approval evidence generation (critical for NICE/EVA funding and broad reimbursement). PICI/CVC context: The April 14, 2026 integration emphasizes data-rich, immune-education platforms. PICI has ongoing AI collaborations (e.g., single-cell analytics via Immunai). NWBO’s lysate-based (broad-antigen, no sequencing required) approach + deep survival data pairs naturally with AI, offering an orthogonal edge to sequencing-heavy mRNA/neoantigen players (Moderna/Merck, BioNTech). Broader field leaders (e.g., Yale’s Immunostruct ML model, Genevation’s AI mRNA design) integrate AI from the start, but they lack NWBO’s validated long-term human outcomes. NWBO could license or partner its dataset for AI model training—creating non-dilutive value and accelerating platform expansion.How This Compares to Peers DC-specific competitors: Diakonos (Phase 2 GBM ongoing since ~2025; Phase 1 data recent) and AiVita (Phase 2 ~2018–2023) have promising early signals but lack decades of cumulative data or long-tail validation. Dendreon’s Provenge has approval-era data but is prostate-limited and older tech.synapse.patsnap.commRNA/neoantigen leaders: Excellent AI integration by design, but shorter real-world empirical history outside COVID-scale use; their data is high-velocity but not yet 20-year longitudinal in solids like GBM. Net effect: NWBO’s data + AI potential widens its moat in autologous DC vaccines for GBM/solids. It turns historical “development time” into a competitive advantage—especially as PICI/CVC shifts the field toward evidence-based, durable-response platforms.Bottom line: These factors absolutely matter and reinforce NWBO as the most vertically integrated, evidence-rich player in its lane. The 20-year dataset provides regulatory and clinical credibility that is difficult to duplicate, while AI compatibility positions it to leverage the next wave of data-driven innovation in the PICI/CVC ecosystem. Execution (approval, manufacturing scale, partnerships) remains key, but on these dimensions, NWBO stands out. This assessment draws from public trial records and ecosystem trends as of April 2026.Yes—NWBO’s 20+ years of cumulative empirical clinical data and the inherent potential for AI/data-science integration are significant differentiators that further strengthen its positioning in the autologous DC vaccine niche (and the broader PICI/CVC-accelerated cancer vaccine ecosystem). These elements complement the patent portfolio, Phase 3 maturity, and manufacturing scalability already discussed, creating a uniquely defensible “data moat” that newer or less-mature competitors cannot easily replicate.20+ Years of Empirical Data: A Rare Long-Term Evidence BaseDCVax-L (and the broader DCVax platform) has been in human clinical testing since the early 2000s, with:Phase I/II trials (UCLA, led by Dr. Linda Liau) starting around 2000–2002: 39 patients (newly diagnosed + recurrent GBM/gliomas + other indications like ovarian). Long-term follow-up data (updated through 2011) showed median overall survival (OS) roughly 2.5× historical controls, with 33% of patients reaching/exceeding 48 months and 27% reaching/exceeding 72 months. By 2013, at least two patients exceeded 10-year survival. Phase 3 DCVax-L trial (331 patients, NCT00045968): Enrollment 2007–2015; mature long-term data published in JAMA Oncology (2023) demonstrated extended median OS and “long-tail” survival in both newly diagnosed (19.3 months vs. 16.5 months historical/external controls) and recurrent GBM (13.2 months vs. 7.8 months). This was the first systemic therapy in ~20 years (newly diagnosed) or ~30 years (recurrent) to show such extensions in GBM. Compassionate use + DCVax-Direct Phase I/II: ~600 total GBM patients treated across programs + data from inoperable solids (some 2–3+ year survivors in top responders). Total platform exposure spans >20 years of real-world-like human data.nwbio.comWhy this matters: GBM has historically had dismal, short survival curves. NWBO’s dataset uniquely captures the long-tail effect (durable responders living years longer), which is rare and highly valued by regulators, payers, and the PICI/CVC network (which prioritizes immune-education modalities with durable memory responses). It enabled external-control analyses (ethically necessary due to crossover), supports real-world evidence (RWE) submissions, and de-risks regulatory pathways (e.g., ongoing UK MHRA review). No other autologous DC program (Diakonos DOC1021, AiVita AV-GBM-1, etc.) has comparable longitudinal depth—theirs are mostly Phase 1/2 from the 2020s with shorter follow-up and smaller cohorts.clinicaltrials.govThis empirical track record builds investor/regulatory credibility and positions NWBO for faster combo trials or label expansions in the post-PICI/CVC ecosystem.Potential Combination with AI Platform DevelopmentNWBO has not publicly announced a proprietary AI platform, but its massive longitudinal dataset (immune-response profiles, survival curves, manufacturing records, patient biomarkers) is an ideal training/validation asset for modern AI/ML tools. Here’s why it factors in strongly: AI synergy in the ecosystem: Personalized cancer vaccines increasingly rely on AI for neoantigen prediction, patient stratification, response forecasting, manufacturing optimization, and RWE generation. New 2026 FDA/MHRA/EU guidances explicitly embrace RWE, human-centric data, and AI-driven analysis—precisely what NWBO’s 20-year human trial archive provides (vs. animal models or short trials). Community analyses (e.g., Gemini/Grok on MHRA/FDA RWE rules) already highlight direct applicability to DCVax.@peter_brit

$nwbo @alphavestcap pfizer.com/news/press-rel… PhalanxWarrior15m@Zorch305 Will Pfizer compete in a bid for a NWBO partnership? Found it. On January 27, 2026, the Cancer Vaccine Coalition (CVC) and the American Association for Cancer Research (AACR) convened a first-of-its-kind global think tank called “Transforming Cancer Care: A Global Think Tank to Accelerate Advances in Cancer Immunity”, bringing together over 50 leading cancer vaccine researchers, clinicians, and cross-sector experts. The event was supported by HSBC Innovation Banking, Northwest Biotherapeutics, Pfizer, and Anixa Biosciences. So NWBO and Pfizer were two of the four sponsors — notable company to be in, especially for a small pre-revenue biotech. It signals NWBO is being taken seriously in the broader cancer vaccine ecosystem.​​​​​​​​​​​​​​​​1 x.com/d_stock07734/s… $NWBO PREVNAR 13 labeling.pfizer.com/ShowLabeling.a… Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) Combined With Immune Checkpoint Inhibition After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer clinicaltrials.gov/study/NCT03942… Dendritic Cell Vaccine + Prevnar + Checkpoint Inhibitors After High-Dose Radiation for Unresectable Liver Cancer Abstract 3741: Radiation-dendritic cell combination therapy drives systemic cellular immune shifts in liver cancer (April, 2026) aacrjournals.org/cancerres/arti… 653 Phase I/II clinical trial for radiation and dendritic cell combination immunotherapy in patients with unresectable hepatocellular carcinoma and cholangiocarcinoma (November, 2024) jitc.bmj.com/content/12/Sup… 689 Preliminary results of a pilot study of intratumoral injection of autologous dendritic cells after high-dose conformal external beam radiotherapy in unreseltable primary liver cancers (December, 2022) jitc.bmj.com/content/10/Sup… Davis@peter_brit·10h#dcvax $nwbo #gbm Big news !!! "I've been so excited to share some big news with you!  From the beginning, Cancer Vaccine Coalition was built for one thing: to be a catalyst. Our mission was to break down silos and build global collaborations to accelerate cancer vaccines.

📷flipper44 $nwbo @alphavestcap Tuesday, April 14, 2026 1:03:26 PM It is the 137th day (possibly out of 153) since the November 28, 2025 CHM meeting.

$nwbo @alphavestcap x.com/peter_brit/sta… x.com/d_stock07734/s… x.com/d_stock07734/s… x.com/parkerici/stat… prnewswire.com/news-releases/… #dcvax $nwbo #gbm The Parker Institute for Cancer Immunotherapy (PICI) represents a paradigm shift in oncology research, operating as a "collaborative engine" rather than a traditional funding body. The recent integration of the Cancer Vaccine Coalition (CVC) into PICI (formally announced April 14, 2026) creates a powerful synergy for platform technologies like Northwest Biotherapeutics' (NW Bio) DCVax 1. PICI Expertise & Collaborative Network PICI’s expertise lies in its "network effect," uniting elite institutions (UCLA, Stanford, UPenn, Dana-Farber) to share data and IP. Its core focus areas align directly with the DCVax value proposition: In situ and Exogenous Vaccines: PICI is prioritizing personalized vaccines that can educate the immune system to recognize a patient’s specific tumor neoantigens. Tumor Microenvironment (TME) Reprogramming: PICI researchers specialize in "flipping" the suppressive environment of solid tumors to allow immune cells to function. Next-Gen Cell Therapy: Beyond CAR-T, PICI is heavily invested in cell-based therapies that offer durable, long-term memory against cancer. 2. Synergy with DCVax Platform & CVCThe inclusion of the Cancer Vaccine Coalition under the PICI umbrella is a major catalyst for the DCVax platform. DCVax-L (using tumor lysates) and DCVax-Direct (injected into inoperable tumors) serve as the "engines" that provide the immune system with the necessary target information.The Synergy Points:Standardization of Trials: The CVC brings expertise in trial design specifically for vaccines. This helps NW Bio navigate the "long tail" survival data, which traditional trial metrics (like Median Progression-Free Survival) often fail to capture accurately.Combination Therapies: PICI’s "Network of Inventions" focus on checkpoint inhibitors (anti-PD-1/L1) is the perfect partner for DCVax. While DCVax creates the "army" of T-cells, PICI’s expertise in inhibitors "takes the brakes off" that army, potentially increasing efficacy in "cold" tumors like Glioblastoma (GBM). 3. Flaskworks: The "Global Franchise" Enabler For NW Bio to achieve a global franchise, the bottleneck has always been manufacturing. Dendritic cell vaccines are notoriously difficult and expensive to produce at scale. The Role of Flaskworks: This automated, closed-system manufacturing technology (acquired by NW Bio) is designed to replace labor-intensive "clean room" processes with automated units. Synergy with PICI/CVC: PICI values scalable, commercially viable breakthroughs. By integrating Flaskworks, NW Bio moves from a "bespoke boutique" model to a "high-throughput franchise" model. This allows for rapid expansion into PICI’s network of affiliated hospitals across the globe. 4. Valuation & Global Aspirations The valuation of NW Bio (currently approx. $400M–$500M market cap) reflects its status as a "binary" biotech—high risk with massive potential upside. Asset Value: The value lies not just in DCVax-L for GBM, but in the platform. If DCVax + PICI-backed combination therapies prove successful in other solid tumors (lung, pancreatic, etc.), the addressable market expands from thousands of patients to millions. Valuation Analysis: From "Single Asset" to "Global Franchise" The market currently values NW Bio primarily on the potential of DCVax-L in Glioblastoma. However, a deep research analysis suggests a much higher "Platform Valuation": In-Licensing Leverage: NW Bio paid approximately $2.3M in milestones + royalties for the Roswell Park IP. This is an extremely low cost for 20 years of NCI-funded research. By absorbing this IP, NW Bio effectively "defended" its territory against competitors who might try to build a better dendritic cell vaccine. Pipeline Expansion: The Kalinski IP covers Phase II trials in breast, colorectal, and ovarian cancers. NW Bio now has a "shadow pipeline" that is already being funded by grants, meaning the company gets clinical data without the immediate cash burn. The PICI Multiplier: Companies associated with PICI often see higher valuations because PICI de-risks the science. As NW Bio’s technology is used in PICI-sponsored combination trials, the "proof of concept" extends to all solid tumors. Franchise Potential: By owning the manufacturing (Flaskworks) and the specialized service (Advent BioServices), NW Bio is vertically integrated. This makes them an attractive partner for Big Pharma companies looking to enter the personalized vaccine space without building their own infrastructure. Flaskworks & Sawston: The Scale-Up Infrastructure The "Global Franchise" aspiration is only possible if the product can be manufactured cheaply and locally. The Sawston Hub: NW Bio’s facility in the UK (recently expanded with Grade C suites) is the first of many planned regional hubs. Flaskworks Automation: By integrating Kalinski’s complex DC-polarization protocols into the automated Flaskworks system, NW Bio can produce "enhanced" vaccines without the massive labor costs of manual lab work. This is the "secret sauce" for global scalability—turning a complex medical procedure into a standardized, manufactured product. The "PICI Stamp": Being part of the PICI/CVC ecosystem provides institutional credibility that can lead to non-dilutive funding, grants, and high-profile collaborations that traditional micro-cap biotechs cannot access. Strategic Outlook The path forward for NW Bio and its global aspirations hinges on Automation + Combination. Potential for Global Aspirations NW Bio is positioning itself as the "Amazon of Personalized Medicine" for solid tumors: They own the Product: DCVax (The Engine). They own the Enhancements: Kalinski/Roswell IP (The Fuel). They own the Factory: Flaskworks/Sawston (The Logistics). They have the Network: PICI/CVC (The Distribution). Automation: Utilizing Flaskworks to lower costs and increase throughput. Combination: Using PICI’s research to pair DCVax with the next generation of immune-modulators. As the Cancer Vaccine Coalition integrates into PICI, the emphasis on neoantigen-based personalized medicine will likely bring DCVax’s "whole tumor lysate" approach back into the center of the immunotherapy conversation, as it captures the full spectrum of a patient's cancer rather than just a single target. This deep-research analysis integrates the high-level collaborative power of the Parker Institute for Cancer Immunotherapy (PICI) and the Cancer Vaccine Coalition (CVC) with the specific, high-value in-licensing agreement between Northwest Biotherapeutics (NW Bio) and Roswell Park Comprehensive Cancer Center, led by Dr. Pawel Kalinski. The addition of the Kalinski/Roswell Park portfolio transforms NW Bio from a "one-product" company (DCVax-L) into a master developer of a massive Dendritic Cell (DC) ecosystem. The Kalinski In-Licensing: The Missing Piece of the TME Puzzle The exclusive license secured by NW Bio (announced June 2024) covers over 20 years of research by Dr. Pawel Kalinski. While DCVax provides the "engine," Kalinski’s technology provides the "navigation and fuel." TME Reprogramming: Kalinski is the pioneer of "DC1" polarization. Standard dendritic cells can sometimes become "tolerogenic" (telling the immune system to ignore the cancer). Kalinski’s IP involves a specialized cocktail (including TLR agonists and interferons) that forces DCs into a "pro-inflammatory" state, ensuring they aggressively activate T-cells. The Checkpoint Synergy: A major reason checkpoint inhibitors (like Keytruda) fail is because the tumor is "cold"—meaning no T-cells are present. Kalinski’s licensed methods specifically reprogram the tumor microenvironment to attract T-cells, effectively "warming up" the tumor so that PICI’s network of PD-1/L1 drugs can actually work. Conclusion for Investors/Analysts: The combination of PICI’s collaborative power and Dr. Kalinski’s TME-reprogramming IP creates a "moat" around the DCVax platform. The move to incorporate Roswell Park’s research into the NW Bio fold suggests that the company is no longer just looking for a UK approval for brain cancer; they are building the infrastructure to treat the 80% of cancers that currently do not respond to immunotherapy. The valuation floor is set by the GBM data, but the ceiling is virtually non-existent if the Flaskworks-automated, Kalinski-enhanced DCVax becomes the "backbone" therapy for PICI’s combination trials globally (Gemini AI Analysis) parkerici.org x.com/peter_brit/sta… ViewsLast edited11:16 AM · Apr 14, 2026·530