Hartland: "It has been several months since we were told that the DSMB and Clinical committee were discussing changes to the FA for statistical reasons not clinical,whatever that means. Did they make a decision? Bear guessed  Sept ..Oct  for 125 events.....why are we in the dark for news of a change?Anyone have an opinion of why any such change. Which I suppose has taken place is secret.......Bear to pose to you a question.If the Dsmb had done a FA at 125 and found no statistical difference would it be in their power to say carry on to a higher number of events "for statistical relevance.""

Hartland, we are all frustrated and impatient. We have 33 days until the Dec. 12th AGM. I expect that between now and then we will be learning a lot. As for the discussions between the DSMB and CSC and how it relates to changes to the futility analysis.....I am not a biostatistician. I'm a biochemist, though I much prefer the bio part than the chemistry part. I do stat analysis when needed, but I am by far not an expert....especially when it comes to clinical trial statistics. Patience. Dec 12th will be here soon.

Koo: "Did we not touch up on the issue of the FA and the delay thereof. I believe the assumption is that the FA needs to include statistical analysis to include patients from the USA and hopefully Canada...and we're not there yet."

That may be your assumption, but not mine and I doubt that it is a widely held assumption. Seeing as there are zero patients enrolled from USA yet, and seeing as there are no plans to include Canada patients at this time, how can you say that the futility analysis is dependent upon events being contributed from USA patients? What info has lead you to this assumption? Just a guess? Even if what you suggest is true (and there is no evidence for this) how many MACE events of the 125 (50%) or ~188 (75%) do you suggest would be needed to be contributed from the USA cohort to appease Koo's suggested demands of the DSMB/CSC? If this is truely your belief, talk us through it. Otherwise, drop this baseless idea.