On May 22, 2025, the UK’s MHRA launched a public consultation on the acceptability of external control arms (ECAs) based on real-world data (RWD) — the exact design used in NWBO’s DCVax-L submission for GBM. The consultation remains open until June 30. But here’s the problem:
This consultation is 17 months too late.
DCVax-L’s statistical analysis plan (SAP) — using RWD-based ECA — has already been peer-reviewed, reviewed by the MHRA, and discussed in CHM. The MHRA has also completed site inspections, issued RFIs, received responses, and granted full GMP + procurement licensing to Advent.
So why launch a consultation now?
Because this is not a scientific need. It’s regulatory cover. The MHRA is likely preparing to approve a treatment without a traditional randomized control arm — and wants procedural insulation from criticism. They’re building a paper trail that says: “We asked the scientific community first.”
It’s smart politics. But make no mistake:
This is not about discovering best practices — it’s about protecting institutional reputation before issuing a precedent-setting approval.
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