NorthWest Biotherapeutics Inc (NWBO)

[MI Dendream]

The FDA recently approved two separate registrational trials for two separate drugs in GBM that use synthetic external controls (blended with small randomized placebo). What would make anyone believe that FDA approved of those comparative datasets but would not accept Dr. Linda Liau’s external dataset built of placebos collected from contemporaneous rigorous regulatory trials?

Hello, FDAs footprint is all over this study since August 2015 which really means June-July 2015. The guidance was initially given under Gotleib’s watch. IMO FDA has already provided positive guidance on their SAP. They cannot share this with us easily as this guidance is non-binding and likely verbal.

Thanks for this reference, PGSD