Saturday, August 30, 2008 9:52:42 PM
We know that RD-1 dosing was completed prior to June 18. For arguments sake, let's say that procedural problems did occur in RD-1, but the DSMB wasn't aware of the problems until after the dosing was completed, and then it was too late to take any corrective action. Wouldn't the DSMB have still told Cortex about the problems they had detected?
Answering my own question - yes they would have notified Cortex. In that case, Stoll would have a pretty good idea that RD-1 was in serious trouble, especially after having seen what happened in RD-2 (ie - the same type procedural problems turning 2 cohorts into data 'mush'). That being the case, would Stoll actually say - "we do not have any insight into how the trial turned out at this time"? Stoll has always been a straight shooter, and I don't think he would have said that if the DSMB had told him 2-3 months ago they had found procedural problems in RD-1.
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