NorthWest Biotherapeutics Inc (NWBO)

[Slave1]

Thanks for weighing in, Froggmister. I think this is a case where there’s just a bit of nuance getting lost in translation.


You’re absolutely right that NWBO did not have access to individual patient-level data from the external comparator trials. That’s confirmed directly by Dr. Liau in the Neurology Journal Podcast on March 2, 2023. She made it clear that the external control data came from previously published trials and that those datasets were only available in aggregate form.


But that’s just one side of the equation.


NWBO did have full individual patient-level data for its own DCVax-L trial participants. That is how they were able to conduct detailed analyses like delayed treatment effect modeling, survival over time by subgroup, and other landmark statistical methods that require patient-level granularity. Without IPD from their own arm, those analyses would not have been possible.


So here is the full picture:

• NWBO had individual patient-level data for the treatment group.

• They did not have IPD for the comparator RCTs, so they used a method called MAIC, Matching Adjusted Indirect Comparison.

• MAIC is a well-established approach for adjusting baseline characteristics when you only have aggregate-level data from comparators.

• Dr. Liau noted this was a limitation, but also emphasized that it was the best available option in the absence of full IPD from legacy trials.

• The MHRA accepted this framework, escalated it to the Commission on Human Medicines for expert review, and went further by expanding the early access program.

That last point really matters: if the lack of external IPD were a fatal flaw, none of those steps would have happened. MHRA clearly judged that the analysis met the bar for serious regulatory consideration.



🔍 Analogy:

It’s like saying a chef didn’t cook a meal because they didn’t grow the vegetables.In truth, the chef had full control over their main ingredients, crafted the dish carefully, and substituted responsibly when some outside ingredients weren’t available. The regulators at MHRA tasted it and invited more people to the table.