NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

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.”

I don’t believe the MHRA is waiting for the outcome of its May 2025 consultation on the draft guideline ‘MHRA draft guideline on the use of external control arms based on real-world data to support regulatory decisions’ before approving DCVax-L.
On 31 December 2024, they approved tarlatamab (Imdylltra) for adult patients with extensive-stage small cell lung cancer (SCLC) after at least two prior lines of therapy, based on a Phase 2, open-label, dose-ranging study (DeLLphi-301) with no control arm. The approval was supported by a 40% objective response rate in the 10 mg group. No formal RWD framework or consultation preceded that decision.

https://www.gov.uk/government/news/tarlatamab-approved-to-treat-adult-patients-with-small-cell-lung-cancer