Replies to post #430733 on NorthWest Biotherapeutics Inc (NWBO)

[IkeEsq]

Could you explain what crossover is and why that would be a problem

In the Phase III trial, patients in the control arm who got the placebo could 'cross over' to the treatment arm and get DC-Vax if their tumors reoccurred (progressed). In the end, 90% of patients received DC-Vax. That makes comparison between the Treatment arm and Control arm more complicated as there are now three groups and a much smaller number of patients only getting the placebo.

[ATLnsider]

The crossover option in the DCVax-L Phase III clinical trial allowed any trial ndGBM patient who had disease progression, to be treated with DCVax-L. This crossover option allowed control or placebo (patients treated with only SOC) patients to crossover, and be treated with DCVax-L.

The crossover is not a problem. Any potential crossover problems were eliminated with the new SAP (Statistical Analysis Plan) for the DCVax-L Phase III trial, and the revised Primary and Secondary endpoints. The revised SAP and new endpoints received buy-in from all 4 regulatory agencies (FDA, MHRA, EMA & Health Canada).

[Long and gone]

Ty. So while it may disrupt the trial to the extent that there are not as many getting the placebo i would think this speaks loudly to the fact that dcvax is working. I would say overall this is actually extremely positive. Is that a fair assumption?