$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
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drive.google.com/file/d/1qvB…