NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

FDA & NWBO agreed that PFS was the primary endpoint - and DCVax-L didn't meet the primary endpoint. And right before the datalock, NWBO changed the protocol, the endpoints, the comparator - violating FDA guidance. Introduce significant bias into the trial that makes FDA very unhappy. And voila, FDA won't accept the data from the trial. That simple. NWBO has had almost three years to file with the FDA and has not.