$NWBO Another glioblastoma patient who needs DCVax ASAP and having to travel to the UK to get the American made vaccine!! @FDA This should not be happening! My body my choice! Right to try! Patients don't have the luxury of time and money for this! #GBM @DrOz @realDonaldTrump

@alphavestcap $nwbo In the U.K., Dc vax L is poised to be granted tumor agnostic maa approval by the mhra . In the U.S., the FDA is poised to grant dc vax L "right to try" approval. If in GBM(x.com/alphavestcap/status/21…) has shown 50% survival at 2 years (no side effects), versus 18-25% with SOC(chemo included), will regulators continue to be instructed to deny ? And on 10/8/26, the NHSBT-MHRA said dc vax L works on all solid tumors (NHS Blood and Transplant’s Therapeutic Apheresis Services (TAS) and Cellular and Molecular Therapies (CMT) teams are supporting the UK production of DCVax®-L – a treatment for Glioblastoma multiforme (GBM), an aggressive form of primary brain cancer, as well as all solid tumours.). nwbio.com/northwest-biothera… x.com/alphavestcap/status/21… x.com/alphavestcap/status/21… x.com/alphavestcap/status/21… x.com/alphavestcap/status/21… x.com/alphavestcap/status/21… Before the MAA could be issued, the MHRA wanted the FDA to approve dc vax L 's BLA. The MHRA's signal to the FDA that the MAA would be approved was (nwbio.com/northwest-biothera…).Stephen Moore then (x.com/HollensbeAmanda/status…) signals to the MHRA that the FDA approval will be "right to try". GMP approval in the U.S. is signaled to the MHRA by (nwbio.com/northwest-biothera…) and especially with Shannon joining $nwbo. $nwbo had signaled long ago that the GMP certification process had started a year ago.(10Q-6/30/26-sec.gov/Archives/edgar/data/… ) nwbio.com/northwest-biothera… nwbio.com/northwest-biothera… @JdBell20 Go look at Amgen in 1984. They were in the exact same boat as NWBO—amazing science, zero cash, and facing total wipeout. They had to survive by giving away 50% of their prize asset to a Japanese beer company just to fund the trials and scale x.com/HollensbeAmand…

As we approach an MHRA MAA decision date, after all of the misinformation campaigns and heavy manipulation contributing to NWBO’s NASDAQ delisting in ‘16, as well as, extremely depressed valuations on OTC, if the folks behind the algorithms etc., might have a different opinion about DCVaxL, if they were faced with a life threatening disease such as GBM?

$NWBO #DCVax #DCVaxForBraelyn #GBM #RareDiseases #CancerVaccines #Immunotherapy #PatientAccess 𝗙𝗗𝗔 𝗜𝗦 𝗔𝗦𝗞𝗜𝗡𝗚. 𝗡𝗢𝗥𝗧𝗛𝗪𝗘𝗦𝗧 𝗦𝗛𝗢𝗨𝗟𝗗 𝗔𝗡𝗦𝗪𝗘𝗥. @FDA’s October 28 meeting is a concrete opening for DCVax-L and DCVax-Direct. Rare cancers bring small patient populations, limited time and difficult evidence questions. Patient-specific cell therapies add complex manufacturing. FDA’s Rare Disease Framework initiative puts those problems into the same conversation: attainable evidence, patient input, coordinated review and risk-based manufacturing assessment. The framework is being developed; existing approval standards still apply. 𝗕𝗥𝗜𝗡𝗚 𝗕𝗢𝗧𝗛 𝗣𝗥𝗢𝗚𝗥𝗔𝗠𝗦 𝗙𝗢𝗥𝗪𝗔𝗥𝗗 One platform strategy. Two product-specific evidence cases. DCVax-L brings an existing Phase III clinical record. Northwest’s 2026 external comparisons using individual-patient data report median-survival differences of 3.4–6.3 months in newly diagnosed glioblastoma. Those analyses deserve direct FDA assessment alongside the complete trial history, including crossover and the unsuccessful original progression endpoint, and the bridge from studied manufacturing to the proposed commercial process. DCVax-Direct brings a different clinical opportunity: prepared dendritic cells are placed into the tumor, where they are intended to acquire its antigens. A tumor that cannot be removed may still be safely reachable for injection. Its early human study provides safety and biological observations on which to build. Define the exact product version, establish comparability with earlier manufacturing, and bring FDA a focused rare-cancer study with clear endpoints. 𝗣𝗘𝗥𝗦𝗢𝗡𝗔𝗟𝗜𝗭𝗔𝗧𝗜𝗢𝗡 𝗖𝗔𝗡 𝗕𝗨𝗜𝗟𝗗 𝗢𝗡 𝗔 𝗥𝗘𝗨𝗦𝗔𝗕𝗟𝗘 𝗣𝗥𝗢𝗖𝗘𝗦𝗦 The patient’s tumor information varies. Cell preparation, functional assays, manufacturing controls and delivery infrastructure can carry forward when their applicability is demonstrated. That is a substantive platform advantage worth developing: each small population can help answer the next clinical question with valid prior knowledge already in place. 𝗖𝗢𝗡𝗡𝗘𝗖𝗧 𝗧𝗛𝗘 𝗣𝗥𝗢𝗗𝗨𝗖𝗧 𝗧𝗢 𝗧𝗛𝗘 𝗣𝗔𝗧𝗜𝗘𝗡𝗧’𝗦 𝗢𝗨𝗧𝗖𝗢𝗠𝗘 Cells collected → product manufactured → batch released → dose administered → outcomes followed. Product release and actual treatment are separate events. Link the dated records, preserve product and process versions, and include patients who deteriorate before dosing. Otherwise, an analysis can credit treatment with survival that occurred before treatment began. This is how existing clinical and compassionate-use experience can become usable evidence. Recover complete cohorts, establish credible comparisons and measure outcomes patients value. 𝗨𝗦𝗘 𝗠𝗘𝗖𝗛𝗔𝗡𝗜𝗦𝗠 𝗔𝗡𝗗 𝗔𝗖𝗖𝗘𝗟𝗘𝗥𝗔𝗧𝗜𝗢𝗡 𝗪𝗜𝗧𝗛 𝗔 𝗗𝗘𝗙𝗜𝗡𝗘𝗗 𝗝𝗢𝗕 Plausible-mechanism reasoning should identify what the product must do and what to measure, with FDA agreement on its application. A Commissioner’s National Priority Voucher is a separate option to assess for an eligible, prepared program. Each belongs in a concrete regulatory strategy with its own requirements. 𝗧𝗛𝗘 𝗡𝗘𝗫𝗧 𝗦𝗧𝗘𝗣 𝗛𝗔𝗦 𝗔 𝗗𝗔𝗧𝗘 Public meeting: October 28, 2026, 1–5 p.m. Eastern. Written comments: October 28–December 11, docket FDA-2026-N-12214. Northwest should submit a specific case for both products and pursue product-specific FDA meetings in parallel. Bring patients, clinical evidence, functional measurements and manufacturing into one accountable development plan. 𝗧𝗵𝗲 𝗻𝗲𝘅𝘁 𝗿𝗮𝗿𝗲-𝗰𝗮𝗻𝗰𝗲𝗿 𝗽𝗮𝘁𝗶𝗲𝗻𝘁 𝘀𝗵𝗼𝘂𝗹𝗱 𝗯𝗲𝗻𝗲𝗳𝗶𝘁 𝗳𝗿𝗼𝗺 𝘄𝗵𝗮𝘁 𝘁𝗵𝗲 𝗽𝗿𝗲𝘃𝗶𝗼𝘂𝘀 𝗽𝗿𝗼𝗴𝗿𝗮𝗺 𝗹𝗲𝗮𝗿𝗻𝗲𝗱. Full illustrated analysis and companion video: x.com/andrewcaravello/articl… Focused LinkedIn article: linkedin.com/pulse/fdas-rare…

$NWBO Addressing CHM concerns through oral presentation is a very bullish sign! See what happened after CHM's request for oral presentation? Has CHM tried to address its concerns through oral presentation before for any other applications?! Northwest Biotherapeutics Announces Keynote Presentation on Harnessing Immunity: A Personalized, Multi-Target Approach to Cancer At the UK National Health Service Annual Oncology Conference convenzis.co.uk/events/cance… NHS Blood and Transplant’s specialist therapeutic apheresis and cell processing capabilities are supporting the production of DCVax®-L nhsbt.nhs.uk/news/nhs-blood-…

$NWBO This is what grok had to say when asked about whether the NHSBT collaboration with NWBO would have been announced if “major” objections, as noted in the Aug CHM Minutes, remained outstanding: No, it is unlikely NHSBT would have publicly announced and operationalized this collaboration (especially the commercial-preparation and expansion elements) if MHRA were clearly headed toward denial of the DCVax-L MAA. What the NHSBT collaboration actually is On 8 October 2026, NWBO and NHS Blood and Transplant announced a collaboration (described as the culmination of months of joint work with Advent Bioservices) to support DCVax-L production. Key operational facts confirmed in subsequent reporting and direct NHSBT correspondence: •Therapeutic Apheresis Services (leukapheresis to collect patient immune cells) and Cellular and Molecular Therapies teams (processing/handling) are already live at Leeds and Oxford. •The collaboration supports both existing compassionate-use/unlicensed treatment arrangements and preparation for commercial rollout following MHRA marketing authorisation. •NHSBT has indicated expansion to additional sites is probable in advance of marketing authorisation; further locations are under discussion. •Patients currently self-fund (not yet NHS-commissioned), but the infrastructure is being built for scale and accessibility. This is not a quiet, purely research or specials-only arrangement. It is a public, operational NHS partnership framed around enhancing scale-up and patient access for DCVax-L. Why this is inconsistent with expected denial NHSBT is a public body with limited specialist capacity (apheresis suites, cell-processing labs, trained staff, quality systems). Publicly committing, announcing, and beginning collections with plans for phased expansion carries opportunity costs, operational burden, and reputational exposure. Doing so while preparing explicitly for post-MA commercial use, and stating expansion is probable before authorisation, would be highly unusual if the parties expected a straightforward MHRA refusal. Quiet support for limited compassionate-use (specials) patients could continue without a high-profile joint announcement and expansion language. The public framing and dual-purpose design point to an expectation of a viable path to broader use. The MAA remains under review (NWBO’s own October 2026 statements and prior MHRA confirmation that it has not been refused, withdrawn, or appealed). No denial has occurred. CHM oral representations context MHRA procedures allow a CHM letter (instead of a standard second RFI) when there are provisional major objections that, if unresolved, could preclude a positive advice. In that case the sponsor is invited to make written or oral representations. This is a defined step in the national assessment procedure, not an automatic rejection signal. August 2026 CHM summary minutes reference a medicine for glioblastoma. Investor discussion of those minutes has focused on a pre-hearing stage in which the Commission reviews the company’s written responses and decides whether an oral hearing is needed to resolve remaining questions. Your premise (CHM requested oral representations based on the August minutes, with a September presentation to address OS/efficacy issues arising from the external-control design) fits this process. Oral representations give the sponsor a structured opportunity to address the specific grounds in the CHM letter. Many applications that reach this stage still receive positive recommendations once the issues (here, likely related to the strength of the overall survival evidence versus external controls, manufacturing consistency, or related CMC points) are satisfactorily addressed. It is not evidence that MHRA has decided against approval. Bottom line •The NHSBT collaboration is a meaningful operational and signalling event consistent with preparation for potential approval and broader use, not with an expected denial.

🇺🇸❤️ WE MET PRESIDENT TRUMP TONIGHT! ❤️🇺🇸 What an extraordinary evening for our family! Tonight, Braelyn, Ben, and I had the incredible opportunity to meet President Trump at the rally in Pendleton, South Carolina! We had only about 20–30 seconds with him, and I knew I needed to make every second count. I introduced him to Braelyn and thanked him for telling Dr. Oz about her brain cancer story. I explained that Braelyn had been diagnosed with glioblastoma, the deadliest type of brain tumor, but that today she is CANCER-FREE after receiving DCVax-L, a personalized cancer vaccine developed right here in America! Yet we must travel all the way to England for her ongoing treatments because we cannot access it here in the United States. Then something pretty cool happened! President Trump turned to one of his staffers and instructed them to get me in touch with Dr. Oz! I also expressed my hope that we could connect with Secretary Kennedy. As our brief time together came to an end, I made one final appeal: “Please help bring this American-made treatment back home to America.” President Trump was incredibly gracious to our family and very kind to Braelyn. We are so grateful for the opportunity to speak with him! Earlier in the evening, I was also able to give a member of his staff a detailed packet about Braelyn’s journey, DCVax-L, and the obstacles American patients face in accessing promising investigational treatments. Now we are praying that the connection with Dr. Oz comes through! Three years ago, Braelyn was given just months to live. Today, she’s 19, attending college, and her latest MRI shows NO EVIDENCE OF DISEASE RECURRENCE! Tonight, we had the opportunity to bring her story directly to the President of the United States. ❤️ My prayer is that this opens the door to a much bigger conversation—one that could change the future for countless American cancer patients. 📸 We were not permitted to bring our phones into the private meeting with President Trump, so we couldn’t take our own pictures with him. His staff took an official photograph of us together, which we’re told will be emailed to us. I can’t wait to share it! In the meantime, here are some pictures from our unforgettable evening. Thank you to EVERYONE who helped make tonight possible and to all of you who continue to share Braelyn’s story. You helped us get this far, and we’re not stopping now! ❤️🙏 @realDonaldTrump @DrOzCMS @WhiteHouse #DCVaxForBraelyn #DCVax

# of days MAA under review to-date - 1,036 back to Dec 20th ‘23. # of MHRA working days for balance of ‘26 - 50 days. From 21 October 2026 (today), 50 working days remain in 2026 for the England & Wales calendar used by MHRA (Monday–Friday, excluding bank holidays). Remaining working days by month Month Working days remaining Notes October 2026 8 From 21 Oct (Wed) to 31 Oct (excluding weekend 24–25 Oct) November 2026 21 Full month; no bank holidays December 2026 21 Full month minus Christmas Day (Fri 25 Dec) and Boxing Day substitute (Mon 28 Dec) Total 50

❤️ IT’S OFFICIAL! WE’RE MEETING PRESIDENT TRUMP TOMORROW! 🇺🇸 Braelyn and I have been invited to attend tomorrow’s rally for Darline Graham in Clemson! We’ll be seated in the VIP section AND have the opportunity to meet President Trump in the “click line”! Ben is cutting his work trip short, and we’re hoping he’ll make it home in time to join us! We’ll have only seconds with the President, but I intend to make every one of them count. I’ll also be bringing information for him and his staff about Braelyn, DCVax-L, and the barriers American patients face trying to access promising treatments developed right here in the United States. This is an extraordinary opportunity, but we’re hoping it can become something even bigger. PLEASE HELP US GET THE ATTENTION OF THE WHITE HOUSE PRESS TEAM! 🙏 We would love the opportunity for a longer conversation with President Trump or his administration about how we can make these treatments accessible to American patients. Please SHARE, REPOST, and TAG anyone who might help get Braelyn’s story in front of the right people! Three years ago, Braelyn was given just months to live. Today she’s 19, attending college, and her latest MRI shows NO EVIDENCE OF DISEASE RECURRENCE! Her story deserves to be heard. And so do the stories of countless other patients fighting for access to promising treatments. @realDonaldTrump @DrOzCMS @WhiteHouse #DCVaxForBraelyn #DCVax #PresidentTrump

I would also like to know what's taking @MHRAgovuk so long to approve $NWBO DCVax.

$NWBO A video letter to President @realDonaldTrump @HollensbeBrae is the young woman whose Glioblastoma story you recently shared with @DrOzCMS. Braelyn and her parents live ten minutes from Wednesday’s campaign stop in Clemson and would like to meet you. “Today she’s 19 years old, attending college, living her life - and her latest MRI shows no evidence of disease.” Braelyn receives DCVax-L, a promising personalized cancer vaccine developed by American scientists (@NorthwestBio). But she can’t get it in the U.S. Her family has to travel back and forth to England for compassionate use. “For three years I fought to save my daughter‘s life and along the way I’ve discovered just how difficult it is for American patients to access promising investigational treatments - even when those treatments were developed right here in their own country. We need to ask some very serious questions about the barriers facing smaller biotechnology companies, the influence of the pharmaceutical industry, and why patients are left waiting while promising treatments navigate years of regulatory hurdles… …You signed right-to-try into law and I tremendously appreciate what that legislation was intended to accomplish, but I’ve learned firsthand that having the right to request a treatment doesn’t necessarily mean a patient can actually obtain it… An American family shouldn’t have to cross an ocean to receive a promising cancer treatment developed by American scientists…” — @HollensbeAmanda

$NWBO Just another “day in the life” of patients being deprived commercial access to a novel immunotherapy that based on P3 trial results, can save their lives and perhaps extend their lives for 5, 10, 15+ years. What is the sense in assigning a PIM designation if the MHRA and CHM both cannot make an informed decision after almost three years? Seems NWBO’s DCVax-L is being held to an “unprecedented” standard of perfection when it comes to the evidence package. To my knowledge, many evidence packages are not perfect. Everyone talks about the high cost of drugs yet drug development can take years and in the end, the low Phase 1 to approval global success rate is just 8-10%. As we know, all drugs must be both safe and effective for patient use. IMO, DCVAX-L has proven that to-date with a PH3 trial that consumed 15 years from first patient enrolled to publication of PH3 results. Supplemental PSM data only improved the reported results in JAMA and other prestigious medical journals publications etc. Yet, somehow, here we are today. Let’s go, patients whose lives depend on therapies such as this one, deserve better! @FDA @MHRAgovuk

$NWBO Unimaginable to-date for a therapy that was assigned a PIM designation, is non-toxic, based on P3 Clinical trial w/supplemental PSM data determined to be both “safe and effective.” CA could have been granted previously prior to the PSM submission, it was not. x.com/i/trending/21056740936…

$NWBO @MHRAgovuk @FDA So after almost three years, this is where Co-Pilot believes things stand, as of today: Let’s tackle this head‑on — because the way you framed it (“MHRA has overlooked evidence including PSM data… in search of bias or possibly challenging external controls… knowing GBM has had no new approvals in 20–30 years”) is exactly the tension point in this entire 900+ day saga. MHRA did not ignore the PSM — they discounted its weight. This is the key distinction. Regulators rarely “miss” evidence. What they do is downgrade evidence they consider methodologically fragile. For DCVax‑L, MHRA’s internal logic looks like this: PSM improves internal validity, but it does not fix the external control problem. So from MHRA’s perspective: • They saw the PSM • They reviewed the PSM • They understood the PSM • They simply did not treat it as decisive That is not “overlooking.” It’s risk‑averse weighting — especially in a solid tumor with historically noisy survival curves. **Has MHRA “overlooked” evidence? No. Has MHRA “under‑valued” evidence? Absolutely.** The PSM module was not ignored. It was absorbed, reviewed, and downgraded. The JAMA paper was not ignored. It was acknowledged, respected, and treated as supportive, not pivotal. The survival benefit was not ignored. It was recognized, but not accepted as sufficiently reliable without a contemporaneous control arm. This is not negligence. It’s methodological conservatism — arguably outdated, arguably harmful, but not unlawful. --- The real issue: MHRA is applying a 1990s evidentiary standard to a 2020s therapy This is the heart of the problem. DCVax‑L is being judged by: • pre‑Brexit oncology norms • pre‑RWE norms • pre‑external‑control norms • pre‑conditional‑approval norms MHRA has not modernized its oncology framework the way FDA and EMA have begun to. So DCVax‑L is stuck in a legacy review mindset. Bottom line MHRA did not overlook the PSM or other evidence. They saw it, reviewed it, and minimized its regulatory weight because: • external controls make them nervous • GBM variability scares them • crossover complicates interpretation • dendritic cell vaccines are unfamiliar • they fear being the first regulator to approve a GBM therapy in decades • their evidentiary framework is outdated This is structural conservatism, not negligence.

$NWBO While another CHM may be planned, based on some quick research, should only be required if the additional PSM data introduced additional uncertainty. Don’t believe that’s the case and obvi may be needed depending on the actions from a prior meeting. As we approach 1,000 days you might reasonably expect a greater sense of urgency considering patient need with this one but why should we expect that to change now?

$NWBO Since December 20, 2023 to today’s date, 986 days with no decision yet. For comparison purposes, this is enough time to: • Build multiple skyscrapers • Construct major bridges • Bore large municipal tunnels • Complete massive infrastructure projects that transform cities Yet in that same span, a single MAA for a therapy addressing a disease with no meaningful survival improvement in 20–30 years remains under review. BioSpace (per Co-Pilot AI) I don’t want to think about just how many patient lives could have been saved during this timeframe.

$NWBO In case anyone is wondering, the MAA “slow” play continues with no end in site. 974 days, as of August 20, 2026.2 Northwest Biotherapeutics (NWBO) submitted its Marketing Authorization Application (MAA) for DCVax-L (for glioblastoma) to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on December 20, 2023. The company announced this the next day (December 21, 2023), stating the application had been submitted the previous day. This date is consistently confirmed in company SEC filings (including 10-Qs and 10-Ks) and multiple reports.3 From December 20, 2023, to August 20, 2026, is exactly 974 days (accounting for the 2024 leap year). The MAA remains under MHRA review as of the latest available updates.

$NWBO per Grok - As of August 12, 2026, it has been 966 days since Northwest Biotherapeutics (NWBO) submitted the Marketing Authorisation Application (MAA) for DCVax-L to the UK MHRA. In oncology, what can reasonably be accomplished within 966 days? In ~966 days (roughly 2 years and 7–8 months), a wide range of meaningful oncology clinical trial work can be completed or substantially advanced. Here are concrete examples and benchmarks: Landmark rapid development example •Osimertinib (Tagrisso) for EGFR T790M-positive NSCLC: First patient dosed in March 2013 → FDA accelerated approval in November 2015. That is approximately 2 years and 8 months (~984 days) from first-in-human dosing to approval. The program included the AURA Phase 1/2 expansion cohorts that generated the response-rate data supporting accelerated approval, plus rapid initiation of the confirmatory Phase 3 (AURA3). This remains one of the fastest modern oncology development timelines from first dose to regulatory approval. Typical and achievable oncology trial timelines within ~966 days •Many Phase 1 and Phase 1/2 trials (dose escalation + expansion cohorts in solid tumors): Frequently complete enrollment, determine the recommended Phase 2 dose, and report preliminary efficacy/safety within 18–30+ months. Median Phase 1 durations in broad datasets are often in the 16–40 month range depending on the indication and design. •Single-arm or randomized Phase 2 trials using objective response rate (ORR), duration of response, or progression-free survival (PFS) as primary endpoints: Commonly finish primary analysis in 2–3 years, especially in molecularly selected populations (e.g., specific driver mutations, MSI-high/dMMR tumors, or rare subtypes). Many basket or precision-oncology Phase 2 studies operate on this cadence. •Portions of larger Phase 3 programs: Enrollment of several hundred patients, interim analyses, and primary PFS readouts are routinely achievable. Full overall-survival (OS) maturity in aggressive diseases often takes longer, but primary endpoint results and regulatory filings based on surrogate endpoints frequently occur inside or near this window. •GBM-specific context: Analyses of glioblastoma trials have shown median durations (start to completion) around 32–40 months for Phase 2 studies and similar or modestly longer for Phase 1 and Phase 3 studies—squarely in the range of (or only modestly beyond) 966 days. What else commonly happens in this timeframe •Multiple sequential or parallel early-phase studies. •Protocol expansions, combination arms, or biomarker-selected cohorts added after initial signals. •Mature follow-up on earlier cohorts (e.g., 2–3 year survival data). •Manufacturing scale-up, process validation, and supporting CMC packages needed for later-stage work or filings. •Generation of peer-reviewed publications and data packages that support regulatory discussions or subsequent trials. Oncology trials (especially those requiring OS endpoints or slow-recruiting populations) can run longer than average, and complexity has trended upward over time. Nevertheless, 966 days is long enough for sponsors to fully execute many early- and mid-stage programs, generate registrational-quality datasets in selected settings, and move candidates meaningfully toward approval—exactly as seen with high-profile examples such as osimertinib. In short: reviewing one complex MAA package is demanding expert work. Running the clinical trials that generate the evidence packages for multiple oncology programmes is a larger, more resource-intensive body of work by almost any practical measure (people involved, patients treated, data generated, operational complexity, and scientific output).