Douglas Charles Duckworth 🇺🇸🇨🇱⚜️🏴‍☠️

$NWBO #DCVax #DCVaxForBraelyn #RareCancer #RareDisease #PatientAdvocacy #PatientAccess #CancerVaccines #Immunotherapy #DendriticCells #CancerResearch @FDA 🧬 𝗔 𝗩𝗼𝗶𝗰𝗲 𝗳𝗼𝗿 𝗘𝘃𝗲𝗿𝘆 𝗥𝗮𝗿𝗲 𝗖𝗮𝗻𝗰𝗲𝗿 Amanda has put her family's experience before the FDA. Every rare-cancer community deserves the same chance to be heard. A diagnosis should help organize care. It should never make a patient disappear from the conversation. FDA is inviting patients, caregivers and advocates to shape its 𝗥𝗮𝗿𝗲 𝗗𝗶𝘀𝗲𝗮𝘀𝗲 𝗙𝗿𝗮𝗺𝗲𝘄𝗼𝗿𝗸 now. The comment period closes December 11, 2026. Operable or inoperable. Adult or childhood cancer. A named subtype or a diagnosis still being worked out. Every rare-solid-cancer community belongs in this conversation. 𝗧𝗵𝗲 𝗰𝗮𝗻𝗰𝗲𝗿 𝘀𝘂𝗽𝗽𝗹𝗶𝗲𝘀 𝘁𝗵𝗲 𝗶𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗼𝗻. “Dendritic cells do bioinformatics for a living.” Dr. Pawel Kalinski DCVax-L loads a patient's dendritic cells with collected cancer material outside the body. DCVax-Direct places prepared dendritic cells into a safely injectable cancerous lesion to encounter that information inside the patient. That is the tissue-agnostic argument: the patient's own cancer supplies the starting information. It does not require patients to share a mutation, a marker or an organ. Dendritic cells process that material, present it and deliver the signals that tell other immune cells how to respond. When a cancer supplies a weak antigenic signal, the quality of presentation and instruction matters even more. Effective recognition combines cancer information with the signals that distinguish danger from healthy tissue. CD4 helper cells license dendritic cells, including the body's own cDC1 presenters, to strengthen killer-T-cell responses. Cancer killing releases further material for presentation. Recognition can widen beyond its starting targets, and memory can carry the lesson forward. The task is to keep recognizing a cancer that changes under treatment while protecting the person. For families, durability means more birthdays and more ordinary mornings together. 𝗧𝗵𝗲 𝗲𝘃𝗶𝗱𝗲𝗻𝗰𝗲 𝗯𝗲𝗹𝗼𝗻𝗴𝘀 𝗶𝗻 𝘁𝗵𝗲 𝗰𝗼𝗻𝘃𝗲𝗿𝘀𝗮𝘁𝗶𝗼𝗻. The full article carries each finding with the product and population it came from. • DCVax-L's published survival findings in glioblastoma, reported against external controls. • The 2026 propensity-score matching and weighting analyses, which re-examine that same treated cohort. • The independent INSIGhT external-control benchmark, tested against a known randomized answer. • The UCLA vaccination-before-checkpoint sequencing report, a different regimen and study, with delayed checkpoint treatment added by amendment. • DCVax-Direct's phase 1 safety and biological findings in 39 evaluable adults. The article connects these findings to low-antigenicity signaling, the CD4 and cDC1 licensing loop, and immune memory. Its safety account stays tied to the product, dose, population and delivery route studied. 𝗪𝗵𝗮𝘁 𝗜 𝗮𝘀𝗸𝗲𝗱 𝗙𝗗𝗔 𝘁𝗼 𝗱𝗼 Use DCVax-L and DCVax-Direct as a public example connecting three practical plans: • Evidence: identify what already counts, what transfers and what each proposed use must establish. • Tissue and manufacturing: preserve suitable cancer material and make responsibility clear before surgery closes that opportunity. • Continuing care: connect a qualified treatment site with supply, travel and coverage so a patient can begin and continue treatment. Measure an instructing cell by what it does. Antigen uptake, presentation and the signals that travel with them are the therapeutic work, and a framework that measures only cell identity will not see it. Name a coordinating office. Publish a workplan within 90 days after the comment period closes. Include patients before the important requirements are fixed. Mechanistic reasoning, suitable real-world evidence, external controls and prespecified Bayesian methods belong in one coherent evidence plan. Shared manufacturing knowledge should travel across diseases. A small rare-cancer community should not have to rebuild the same foundation from the beginning. I submitted the proposal on October 29. FDA's Rare Disease Innovation Hub confirmed receipt and said it would be routed to the appropriate centers. These are the actions I asked FDA to take. This comment period gives every family a chance to put its own needs into the same policy process. 𝗪𝗮𝘁𝗰𝗵. 𝗥𝗲𝗮𝗱. 𝗔𝗱𝗱 𝘆𝗼𝘂𝗿 𝗼𝘄𝗻 𝘃𝗼𝗶𝗰𝗲. 🎥 The companion video introduces the biology and the case for patient participation. 📖 The X article carries the complete essay and sources. 💼 The LinkedIn article connects the biology to the practical policy decisions. 📄 The Diagnosis Companion organizes 507 overlapping profiles of diagnoses and source categories, including historical and related labels. Find the wording on your pathology report, its biological context and language for your own FDA comment. Full X article: teapawt.net/andrewcaravello/articl… LinkedIn article: linkedin.com/pulse/voice-eve… Video: drive.google.com/file/d/1ps8… Diagnosis Companion: drive.google.com/file/d/1Hvi… My FDA proposal: drive.google.com/file/d/1qvB… 𝗦𝘂𝗯𝗺𝗶𝘁 𝘆𝗼𝘂𝗿 𝗼𝘄𝗻 𝗰𝗼𝗺𝗺𝗲𝗻𝘁 Use the proposal and companion to help write your own request. Name your connection to the cancer, one obstacle, the outcome that matters and the change you want FDA to make. An unsettled diagnosis can still be described in your own words. “I am a [patient, parent, caregiver or advocate] affected by [cancer]. Our obstacle is [problem]. The outcome that matters is [outcome]. I ask FDA to include DCVax-L and DCVax-Direct in a public Framework example connecting evidence, cancer-tissue handling, manufacturing and continued access to care. Include our community before key requirements are fixed. This comment addresses FDA topic areas 1, 2, 3 and 4.” FDA asks commenters to name the relevant topics in the comment text: 1 attainable evidence, 2 consistent requirements, 3 patient and expert engagement, 4 manufacturing and product quality. They are separate from the category dropdown. For a personal submission, choose “Individual Consumer” under “What is your comment about?”, then “An Individual”. Enter your own first and last name. A parent or legal guardian writes about their child's cancer in their own name. The comment box accepts 5,000 characters. Each optional attachment must be 10 MB or smaller. Complete verification, select “Submit Comment” and save the receipt. Attaching a file alone does not submit it. FDA form: regulations.gov/commenton/FD… 𝗗𝗲𝗮𝗱𝗹𝗶𝗻𝗲: 𝗗𝗲𝗰𝗲𝗺𝗯𝗲𝗿 𝟭𝟭, 𝟮𝟬𝟮𝟲, 𝟭𝟭:𝟱𝟵 𝗽.𝗺. 𝗘𝗮𝘀𝘁𝗲𝗿𝗻. Comments and attachments are public. This is policy participation, separate from treatment enrollment. I write independently as a physician and patient advocate, not for Northwest Biotherapeutics. 𝗔 𝗰𝗮𝗻𝗰𝗲𝗿 𝗰𝗮𝗻 𝗯𝗲 𝗼𝗻𝗲 𝗶𝗻 𝗮 𝗺𝗶𝗹𝗹𝗶𝗼𝗻. 𝗧𝗵𝗲 𝗽𝗲𝗿𝘀𝗼𝗻 𝗹𝗶𝘃𝗶𝗻𝗴 𝘄𝗶𝘁𝗵 𝗶𝘁 𝗶𝘀 𝘀𝗼𝗺𝗲𝗼𝗻𝗲'𝘀 𝘄𝗵𝗼𝗹𝗲 𝘄𝗼𝗿𝗹𝗱.