Replies to post #809876 on 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.

[SkyLimit2022]

Gro,

Thanks for sharing your free expertise on clinical trials again, but we’ll leave the analyses & conclusions to the independent peer reviewers, the
FDA, & the respected physicians who led the trial.

Dr. Ashkan

Dr. Liau

To clarify the mis- or disinformation, & for details about the DCVax®-L PIII clinical trial, the most comprehensive resource is the independent peer review that was published in JAMA Oncology.



☑️ There are multiple trials & trial designs relevant to NWBO that include either a DCVax product or Roswell’s aDC1 platform.

☑️ Beyond the PIII ECA, DCVax®-L is also being studied in a RCT setting with placebo group.

☑️ As a matter of record, OS was always one of the endpoints for the PIII, but OS replaced PFS as the primary endpoint.

[theorysuit]

You seem to have missed that ECA control arms require PRE-TRIAL design and mutual agreement. NWBO initiated their ECA control virtually POST-TRIAL, announced two weeks before data lock. It's why they aren't having FDA review, because it violated FDA's guidelines. Let's see if MHRA violates their new guidance with the DCVax-L

Don't know what is so hard to understand about this. Nwbo trial failed and they tried some gymnastics instead of admitting failure and redesigning a new trial. Effing simple. This trial as it stands is not apprpvable by any regulatory agency.....they saw the loopholes on the UK PROCESS so they applied here first. If they applied to the FDA, the FDA would have rejected them within the initial confirmation. 2 plus years in and people thinking there is still hope for the UK submission. Lmfao. There might be a final pump on this and if you are a true retail holder you better gtfo on that pump if it ever comes.

[seekinganswers]

"NWBO initiated their ECA control virtually POST-TRIAL"

Not "virtually" .... it actually happened.