NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

The comparator wasn't a "placebo" arm, patients were still treated with a full SoC treatment. The crossover for recurrent GBM patients was a rescue treatment for failures. The original trial protocol was only for naive GBM patients.

NWBO added a recurrent GBM arm AFTER the unblinding when they could look at the naive GBM control arm patients that were treated with DCVax-L as a rescue treatment in the crossover. They could only look at them AFTER unblinding and then they added that endpoint to the new and improved" trial protocol and then they had to create the external comparator as they had none.

All after UNblinding.