NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

The public announcement of the change in protocol WAS two weeks before the data lock. NWBO has months of time to redesign the trial after Dr. Liau's interim analysis made it evident that DCVax-L was going to fail the primary endpoint and the trial. They were desperate to avoid failure so they redid the trial totally including the External Comparators that by FDA Guidelines can only be done PRIOR TO THE START OF THE TRIAL. That's why the FDA clearly rejected NWBO's potential filing and they went to MHRA.