#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?
🚨 MY FINAL TAKE on MHRA’s MIA Update (UK MIA 54923) & DCVax-L! 🚨
MHRA shifting Advent’s MIA from “Human” to Regulation 17 (Wholesale Distribution) is a BIG SIGNAL for DCVax-L’s path to commercialization. Let’s break it down 🧵👇
1️⃣ What This Means: A Distribution Step
🔹 MHRA updated Advent’s MIA on Feb 28, 2025 from “Human” to “Regulation 17”
🔹 R 17 covers wholesale authorization → Advent may now distribute DCVax-L
🔹 Ties into MHRA’s ATMP framework & post-approval steps → Getting DCVax-L to patients
🚀 Not about manufacturing anymore. About getting DCVax-L out the door!
2️⃣ Approval Imminent?
📍 MHRA has been processing DCVax-L’s MAA since Dec 2023
📍 Feb 20 GMP update for Clean Room C = readiness for production
📍 R 17 now updated → signaling potential post-approval steps
🚨 MY TAKE on Advent’s MIA Update
(Feb 27, 2025)! 🚨
MIA 54923 updated again in under a week—Feb 20 GMP, Feb 27 MIA.
What’s up?
🔹 Facility Upgrades Likely – I’m With ChatGPT ✅ – I think this could signal upgrades at Advent’s Sawston site, like enhancing capacity or tech (e.g., Flaskworks EDEN for DCVax-L). MHRA’s Feb 20 GMP (1-day cert) —new equipment or processes might need swift MIA updates.
🔹 Scope Expansion Possible – Makes Sense ✅ – I believe Advent might be broadening manufacturing for DCVax-L or new products (e.g., in-licensed tech from 2024). MHRA’s Feb update prioritizes timely approvals—expanding authorized activities fits NWBO’s MAA push (Dec 2023).
Key Question:
Is the “new” Murcidencel trial actually just an update of the old trial, now formally named under its International Nonproprietary Name (INN)?