Over on the Stockhouse board, G1945V was chiming in on my previous statements regarding the sample size analysis and the implications that it could increase patient number up to 3600 and target MACE events to 375. G1945V wrote "My concern is the talk that is going on with having to need 3600 participants to finalize BOM. I don't believe Don ever mentioning that at all. Last he said is that BOM will be over end of 2018. Enough said."

Let's break that down. First "I don't believe Don ever mentioning that at all."

You're right! It was Michael Sweeney, not Don McCaffrey. And it was during the Q1 2016 webcast March 5, 2016, not around the start of the trial in Fall 2015 (as I previously recalled). And the statement did not explicitly state that patient number would be increased to 3600. However, according to my notes from the Q1 2016 webcast, a statement was made by Dr. Sweeney to the effect of "There will be a sample size estimate analysis at 175 MACE events at which time the trial could be adjusted to continue until 375 MACE events." So "if" target MACE increased by 50% from 250 to 375, I think I must have assumed that number of patients would also increase by 50% from 2400 to 3600. I believe that was my logic. It is still reasonable to think that total patient number will need to be increased if the target MACE events are increased to 375. Side note, the more recent language suggests that the sample size re-estimation analysis will occur after 75% of the planned 250 events, which is 188 events.

Next statement "Last he said is that BOM will be over end of 2018. Enough said."

He never said that. In the latest news release 1/11/18, Don was quoted as saying "BETonMACE top line data is still planned to be available around the end of 2018." As of right now, pre-sample size re-estimation analysis (SSRA), the plan is for the trial to enroll ~2400 patients and target 250 MACE events. However, if the number of target MACE events and patients are increased as a result of the SSRA, then the plan will likely change. Don can't predict the future, so as of right now he is assuming that the upcoming SSRA won't lead to a change in the recommended patient enrollment and target MACE. There's a big difference between "will be" and "planned to be."

BearDownAZ