#CancerMoonshot today will not only be about glioblastoma, but about the horrible DIPG (diffuse intrinsic pontine glioma) occuring in children and young adults.
You know who got their PIP plan approved last year by the MHRA in the UK?
You know who ANNOUNCED a new center of cancer excellence in Sutton in the UK two months ago, 130 miles from Sawston, focusing on DIPG?
You know who donated 2.5 million pounds to the center and that Hugh Adams works for them and have helped NWBO meeting british politicians and he wrote the "Pathway to a Cure" report, where politicians urges MHRA and NICE to get DCVax-L to patients?
SAME DAY MHRA announced this
"This new funding will accelerate the delivery of cutting-edge treatments like cancer vaccines"
One week later the MHRA announced this.
The new Quarterly SEC filing says
"We plan to work on preparations for Phase II trials of DCVax-Direct as resources permit."
You know NWBO already had planned DCVax-Direct trials in 2019 targeting DIPG?
Isn't it funny how MHRA Draft Guidance on External Controls, 10 years health plan on personal individualized cancer vaccines, POC and PICV frameworks ... it all seems to "come together" RIGHT NOW?
“Use of External Control Arms Based on Real-World Data to Support Regulatory Decisions”
It focuses on ECAs in situations where randomization is infeasible or unethical.
NWBO’s DCVax-L trial fits that exact profile.
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“While the guideline is specifically aimed at sponsors planning to use RWD ECAs, many of the general principles would be relevant for external controls drawn from other sources, such as previously completed clinical trials.”
DCVax-L was submitted to MHRA on December 20, 2023 and validated on March 7, 2024. This started the official assessment under MHRA’s national procedure for innovative medicines.
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The MHRA process counts only assessment time when the regulator is actively reviewing the file. When they send formal questions (RFI), the clock stops while the applicant prepares a response.
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Each RFI pause allows up to:
• 6 months for the first
• 3 months for follow-up
• 6 months for CHM representation if issued