NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

But they did use patient-level data collected outside of their own clinical trial, which the MHRA now explicitly says falls under the same regulatory principles as RWD-based ECAs.

They absolutely did not use patient level data. The data came from published papers alone.

Patient level data means the baselines characteristics and results for each patient. I.E., patient #88 was male, meth, partial resection., OS os N PFS of N and such. What NWBO used was tables of summary baseline data and K/.M curves.

There is a reason why RAs want patient level data, and it is not because they are stupid or old fashioned.

This study has limitations. Since individual patient-level data for the ECPs were not available for this trial, as is often the case, propensity score matching could not be performed, which is a potential limitation of this study. However, the MAIC analysis applied here is a powerful method to overcome the lack of such individual patient data and to enable matching of specific patient characteristics in external controls compared with patients in the investigational group. This method also has wider general applicability to provide reliable comparative evidence

You could also read he SAP and see this.

And, no, MAIC is nowhere near good enough.