NorthWest Biotherapeutics Inc (NWBO)

[Chiugray]

HyGro, It’s not me saying you are wrong. It is the MHRA’s own Draft Guideline on External Control Arms (section 11) saying you are wrong.

Your statement “require pre-trial design and mutual agreement” is wrong. There is NO requirement.
11. A trial with an ECA is not the preferred clinical trial design as a fully powered randomized controlled trial (RCT) should be used if possible. However, any regulatory decision is based upon the data presented in the submission, and if those data are sufficiently convincing then a positive decision can be reached, even if alternative approaches may have ideally been preferred. Therefore, there is no general scenario where the use of RWD external controls is explicitly ruled out.

MHRA has an additional nail against your statement.
8. 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. MHRA is also interested in engaging with sponsors who have proposals for using such data sources.

https://assets.publishing.service.gov.uk/media/6825bab1a4c1a40fde4e63e5/Draft_MHRA_Guideline_on_Studies_with_RWD_ECA_May2025.pdf


Your statement “Let’s see if MHRA violates their new guidance with the DCVax-L review.”
FYI, if the MHRA publishes guidance, by definition, they are not violating it. They are following it.


The high-level reason PR 1/13/26, which I already posted from the chain you are replying from.
The MHRA’s set of reforms is aimed at helping patients access new cutting-edge treatments more quickly “with faster assessments and agile regulation”. That is their goal.