Steve
3.1K posts





$NWBO Dear @MHRAgovuk , You have to explain to me how a therapy that: 1Shows no meaningful toxicity or serious side effects, 2Demonstrates 13.5% five-year overall survival versus about 5% with the current standard of care, 3Has GMP manufacturing already approved at the Sawston facility (December 2025), 4Was supported by Phase 3 trial results published in @JAMAOncology, 5Targets a disease where no meaningful new therapy has been approved for glioblastoma in more than 20 years can still remain unapproved after more than two years of regulatory review. My concern is not about the therapy itself. The data exist, the safety profile is clear, and the manufacturing capability has already been authorized. The real concern is the inefficiency and heavy bureaucracy within the MHRA process. $NWBO also has a large and highly engaged community following this application. Many people—patients, families, physicians, and investors—are carefully examining every step of this process and trying to understand why a decision continues to be delayed. Given the circumstances, it is natural that people begin asking what the real reason is for the prolonged delay, especially when there are well-known financial interests that have publicly worked against this company for years. At some point, transparency becomes necessary. @Siobhain_Mc @wesstreeting @Nigel_Farage @Keir_Starmer









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