Replies to post #770278 on NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

, it is not accurate to say that the ECA was based on real-world data or included any.

For DCVax-L, the External Control Arm (ECA) was constructed using Real-World Evidence (RWE) from prior clinical trial datasets — not electronic health records or insurance claims, but structured data from published randomized controlled trials:
EF-14 Trial (NovoCure – Optune device)
CENTRIC Trial (testing cilengitide)
ACT IV Trial (rindopepimut/EGFRvIII vaccine)
CheckMate-498 / CheckMate-548 (nivolumab vs. SOC in GBM)
Radiotherapy + TMZ studies (Stupp protocol era)

Also for you to claim the MHRA is lying here "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."
is hilarious and pathetic.

Therefore, your statement is such absolute nonsense that I won't even address the rest of your BS. You are on ignore

[Roman516]

Galzus Research, comments lack truth, IMO

Bogus comments per normal, IMO
"This documentation's timing is coincidental, not illustrative. It has nothing to do with the DCVax trial, because the DCVax trial did not use real-world data. It certainly did not use real-world data in a prospective way from the outset, which is what the guidance is intending to guide on."

NWBO plus Dr. Linda Liau and her team at UCLA have made significant progress and strides with their efforts with DCVax and the data proves it to be true. Hence, your biased comments have no value and are just your opinions, IMPO

[learningcurve2020]

And this is likely not factual either, no matter how many times the pumpers try to push it through.

>>The MHRA has also completed site inspections, issued RFIs, received responses,

[biosectinvestor]

This is where bashers can say something “truthful”, that is fundamentally deceptive. The data NWBO used is from true clinical trials, so it is considered much better than purely clinical data that would be generalized

Real World Data (RWD) refers to data collected outside the context of traditional randomized clinical trials. It includes information on patient health status and the delivery of health care that is routinely collected from a variety of sources, such as:
• Electronic health records (EHRs)
• Insurance claims and billing activities
• Product and disease registries
• Patient-generated data (e.g., from apps or wearables)
• Data from home-use settings or real-world treatment (off-trial)

In contrast, clinical trial data comes from controlled, protocol-driven studies typically considered the highest level of evidence due to their design (e.g., randomization, blinding, defined endpoints).

Real World Data is distinct from clinical trial data and is often used to generate Real World Evidence (RWE) to support regulatory decisions, especially under pathways like accelerated approval, label expansions, or post-marketing surveillance.

For purposes of regulatory approval—especially when constructing an external control arm—clinical trial data from a comparable trial is generally considered much more reliable and of higher evidentiary value than Real World Data (RWD).

1. Controlled Environment
• Clinical trials are conducted under strict protocols, ensuring consistency in patient selection, treatment administration, monitoring, and endpoint assessment.
• This minimizes bias and confounding variables, which are common in Real World Data.

2. Comparable Populations
• If a sponsor has access to data from a prior or concurrent randomized controlled trial (RCT) with a comparable patient population and inclusion/exclusion criteria, it offers a more rigorous and directly applicable control group.
• This is especially valuable for rare diseases or single-arm trials, where constructing an external comparator is necessary.

3. Regulatory Preference
• Both the FDA and EMA have made clear that data from prior clinical trials is preferred over RWD when constructing external controls—if it is comparable and available.
• The FDA’s guidance on external controls (draft 2023) notes that historical clinical trial data is preferred due to higher internal validity.

4. Statistical Matching
• With trial data, it’s easier to statistically match populations and outcomes (e.g., propensity score matching), especially if the trial collected the same endpoints and baseline characteristics as the investigational trial.

Summary:
If a company has access to data from a comparable prior clinical trial, that data is significantly more valuable than RWD for constructing an external control arm. It is closer in validity to a randomized control and is much more likely to be acceptable to the FDA as part of a regulatory submission.

So yes, you are correct. NWBO has better data for its control arm… not just clinical records and poorly controlled data.

[j e d]

MHRA's RWD guidance literally says "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."

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

you need to do way better if you see yourself fit to publish on the matter