NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

NWBO didn't have a choice but to use external comparators as they have confounded the internal placebo comparator arm. The PFS pseudo-progression made the placebo comparator unusable as a control. The cross-over DCVac-L dosing confounded it's use in the OS data.

NWBO didn't identify they were using an SAP with an external comparator until the 3/21 SEC filing. That was 5 months after announcing unblinding of data.

This publication was almost a year after NWBO announced they were using an external comparator. And NWBO didn't have a choice as the inside comparator was double confounded. They also needed an external comparator for the recurrent GBM arm as it wasn't in the original trial design. It wasn't added until after the unblinding.