NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

what is your point? Are you trying to scare us into thinking we need to wait another year for the decision? Because if that's what you are trying to imply, which it looks like you are, then that is misleading.

Here’s what’s really going on, in plain terms:
A. The April 2026 Date Is for Future Trials Not Current Reviews
The April 28, 2026 date refers to the full implementation of the new Clinical Trials Regulations in the UK. That’s for prospective trials, especially those starting after that date. It does not apply retroactively to Marketing Authorisation Applications (MAAs) that are already under review, such as DCVax-L.
B. The ECA/RWD Guidance Is Just That — Guidance
The draft guideline on ECAs based on real-world data was released May 20, 2025, and closes for comment on July 14.
The MHRA explicitly said it will amend and publish the final guideline shortly thereafter.

C, Nothing in the process or MHRA's language suggests they’re tying that to April 2026 that’s a separate legislative date for a different regulation set. DCVax-L Is Already in Review The Clock Started Long Ago
DCVax-L’s application has been under formal review since March 2023.
The current guidance process is widely understood as supportive backfill, not a reason for delay.

If the MHRA had intended to reject DCVax-L under the old framework, they would have done so already it's been 18 months.

If anything, the long review period + the publication of supportive guidance suggests the MHRA is lining up the final steps. Barring any red flags, a decision soon after July 14–31 remains the most logical.

In other words what you are suggesting is misleading