NorthWest Biotherapeutics Inc (NWBO)

[lareineivre]

Including original 33 in number of events favors control:
• at 66 events, adds at least 3-6 percentage points to recurrence % for DCVax and lowers recurrence % for control by at least 9-15 percentage points;
• at 88 events, adds at least 3-7 percentage points to recurrence % and lowers recurrence % for control by at least 8-12 percentage points.

Challenge is communicating efficacy in clear, simple terms given halt in enrollment and transition from Phase 2 to 3, and impact of original 33 on calculations for recurrence / events, PFS and OS.

The effects, which erode over time, are efficacy based on recurrence appears on surface significantly muted, and patients in control with above median PFS and OS will distort those calculations in favor of control compared to a Phase 3 with continuous enrollment and “normal” randomization.