Thanks cabel I understand that the company gets bulk data versus patient reports. I'm trying to get a handle on what types of bulk data any company involved in a P3 double blinded trial would receive.

From the Fact Sheet about DSMB's roles that BDAZ linked to KK2's post it would appears that a DSMB has access to a lot of limited information. This just brought up more questions. One that came to mind is; What would be considered an overwhelming positive effect that would cause the DSMB to recommend ending the randomization and also recommend that all trial participants be offered the intervention (ABL)? Would that be 40%, 50%, 60%, 70% RRR? Since BoM hasn't been halted is it safe to assume we will be under a threshold that would otherwise have caused us to be haunted early? In previous trials there were some pretty spectacular RRR's in patient groups that this trial was designed around.

Also it seemed that the DSMB would normally receive enough data to make a futility call without a specific FA. Bear if you could please comment as to whether I have read to much into this futility aspect it would be appreciated. I do understand that it is hard for the DSMB to draw definitive conclusions from limited data.

tada