Guy New

FDA has responded to my $NWBO #DCVax proposal. Today, the Rare Disease Innovation Hub confirmed that my submission "has been received and will be routed to the appropriate centers for consideration." I submitted a 21-page proposal advocating for DCVax-L and DCVax-Direct under the Rare Disease Framework, beginning with rare cancers. The future I am advocating is a system built to handle personalization from the start. DCVax-L uses a patient's tumor material to load their dendritic cells. DCVax-Direct places prepared dendritic cells into a tumor to acquire tumor material there. Each program has its own evidence requirements. Both make the same larger question impossible to ignore: how do we evaluate a treatment whose patient-specific inputs are supposed to vary? The framework should distinguish intentional personalization from manufacturing inconsistency. Define what must remain reliable, what changes with each patient, and how those differences affect safety and benefit. That distinction can shape the next generation of cancer treatment: 1. Preserve options before surgery. Plan consent, diagnostic allocation, tissue handling and storage while suitable material is still available. 2. Build on what has been learned. State which clinical and manufacturing evidence can be reused, where new evidence is essential, and how to test applications across rare cancer types. 3. Make every study answer a clear question. Connect mechanism, measured biological activity and meaningful patient outcomes. Use external controls and Bayesian methods when their assumptions can be justified and tested. 4. Plan for continuing care. Identify who is responsible for supply, qualified treatment sites, lawful access and financing. Beginning treatment and being able to continue it belong in the same plan. These are my recommendations as an independent physician and patient advocate. I do not speak for Northwest Biotherapeutics. FDA's reply gives us a clear next step: keep the evidence and patient experience in front of the people building this framework. Families can explain where the current system breaks down and what a workable path must provide. The measure of progress will be a family that knows what comes next, who is responsible, and how to reach them while there is still time. Read the proposal: drive.google.com/file/d/1qvB… Add your own comment by December 11, 2026: regulations.gov/commenton/FD… #RareDisease #RareCancer #Immunotherapy #PatientAdvocacy #GBM

$NWBO #DCVax #DCVaxForBraelyn #RareDisease #RareCancer #Immunotherapy #PatientAdvocacy #CancerResearch 🧬 𝗧𝗵𝗶𝘀 𝗺𝗼𝗿𝗻𝗶𝗻𝗴 𝗜 𝘁𝗼𝗼𝗸 𝘁𝗵𝗲 𝗰𝗮𝘀𝗲 𝗳𝗼𝗿 𝗗𝗖𝗩𝗮𝘅 𝘁𝗼 𝘁𝗵𝗲 𝗙𝗗𝗔. A 21-page proposal with 52 cited sources, filed to the public docket for FDA’s 𝗥𝗮𝗿𝗲 𝗗𝗶𝘀𝗲𝗮𝘀𝗲 𝗙𝗿𝗮𝗺𝗲𝘄𝗼𝗿𝗸 and sent to the Rare Disease Innovation Hub with a one-page summary. Both are in the images. My advocacy is specific: 𝗗𝗖𝗩𝗮𝘅-𝗟 𝗮𝗻𝗱 𝗗𝗖𝗩𝗮𝘅-𝗗𝗶𝗿𝗲𝗰𝘁, beginning with rare cancers. I submitted this in my personal capacity as a physician and patient advocate. I am not affiliated with Northwest Biotherapeutics and do not speak for the company. The ask: one published development example connecting three plans, the evidence, the tissue and manufacturing, and the patient’s route to care, so that a patient can begin treatment 𝗮𝗻𝗱 𝗰𝗼𝗻𝘁𝗶𝗻𝘂𝗲 𝗶𝘁. I asked FDA to name a coordinating office, publish a workplan within 90 days of the comment period closing, and include patients before key decisions are fixed. One distinction runs through the whole proposal: more analyses of the same patients are not independent evidence. FDA is inviting patients and advocates to shape this framework now, while it is still being designed. Behind every question about evidence, tissue or access is a family trying to keep someone alive. 𝗥𝗮𝗿𝗲 𝘀𝗵𝗼𝘂𝗹𝗱 𝗱𝗲𝘀𝗰𝗿𝗶𝗯𝗲 𝘁𝗵𝗲 𝗱𝗶𝘀𝗲𝗮𝘀𝗲. 𝗜𝘁 𝘀𝗵𝗼𝘂𝗹𝗱 𝗻𝗲𝘃𝗲𝗿 𝗱𝗲𝘀𝗰𝗿𝗶𝗯𝗲 𝘁𝗵𝗲 𝗮𝘁𝘁𝗲𝗻𝘁𝗶𝗼𝗻 𝗶𝘁𝘀 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀 𝗿𝗲𝗰𝗲𝗶𝘃𝗲. 📄 Docket: FDA-2026-N-12214 ✅ Comment tracking: mvt-lzyl-zjmn 🔗 drive.google.com/file/d/1qvB…