Replies to post #770695 on NorthWest Biotherapeutics Inc (NWBO)

[learningcurve2020]

I already laid them out:

1. Preparing for speedy mRNA trials
2. Preparing for L pediatric trial
3. Preparing for L Plll redux
4. All of the above
5. Just a way to stall the inevitable MAA rejection so to continue raising cash and maybe prove out some new combo treatment.

[evanstony]

Does anyone have a legit explanation for this?

(legit) explanation for the feedback deadline date and the delays.... is overwhelming evidence for more uses .... this is just my opinion and my opinion and is very biased

The Big Surprise.... to be used in many indications

The "we are working closely" and the "seeking feedback" IMO are very positive.

The Kinks.... So tired so tired of waiting for you.... it keeps repeating

The Sylvers
Though the road be dark and dreary
The pathway burning you dry
Feel life really leading us on, girl
We can make it if we try

[dennisdave]

I have been saying this since March (July decision month)
The reason for this is in the article.

[ATLnsider]

jed, this is simply not true. Again, this is an often repeated Bear lie. This MHRA guidance has absolutely nothing to do with the NWBio MAA decision.

NWBio did not use any Real World Data (RWD) in its DCVax-L Phase III clinical trial results analysis.

Instead, NWBio used pooled control arms data from other contemporaneous randomized-controlled trials (RCTs), as its external arm (ECA).

The regulators (FDA, EMA, MHRA, etc.) are all very clear when they explain what type of data is RWD. Here is the link to the MHRA draft RWD ECA guidance below.

Please show me where they said data from other clinical trials or studies is RWD. Instead, they said, several times that RWD data is “outside” of a clinical study:

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

Here is how the MHRA defines RWD and thoroughly explains what constitutes RWD:

For the purposes of this guideline, RWD is defined as data relating to patient health status or delivery of health care collected outside of a clinical study. Sources of RWD include electronic healthcare records (EHR) defined as structured, digital collections of patient level medical data, primary and secondary care records, disease registries, and administrative data on births and deaths. Other sources of RWD include patient reported outcomes (PRO) data and data which are collected outside of a clinical study setting such as through wearable devices, specialised/secure websites, or tablets. 15. A RWD ECA comprises patient level data collected outside of a clinical study which will be used as a control or part of a control arm to estimate the comparative efficacy and safety of an intervention being studied in a clinical trial.