NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

dennisdave, the highlighted section (that you posted) of the FDA guidance does not say what you think it says, nor does it say what you are alleging it says. Here is the exact quoted section:

Although various sources of data can serve as the control arm in an externally controlled trial, this guidance focuses on the use of patient-level data from other clinical trials or from real-world data (RWD) sources, such as registries as well as electronic health records (EHRs) and medical claims

Again, NWBio did not use patient-level data from other clinical trials, or patient-level data from RWD source databases.

Instead, NWBio used pooled control group data, from other external peer-reviewed and published randomized controlled trials (RCTs), to develop their ECA.

This section of the guidance that you quoted, does not support your opinions.