NorthWest Biotherapeutics Inc (NWBO)

[Galzus Research]

DCVax-L’s statistical analysis plan (SAP) — using RWD-based ECA — has already been peer-reviewed, reviewed by the MHRA, and discussed in CHM. The MHRA has also completed site inspections, issued RFIs, received responses, and granted full GMP + procurement licensing to Advent.

While it's true that the SAP was approved, it is not accurate to say that the ECA was based on real-world data or included any.

All of the external control patient data were collected from other clinical trials. Hence, not fitting the definition of "real world" laid out in the very documents you cite.

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.