Sunday, February 05, 2017 11:18:12 AM
"While we may know approx when 60% occurred (sometime last March) and when the company projects the 100% event (but they could be off by a month or two), we cannot know when 80% occurred or will occur."
My argument is that we DO know when the onset of 60% occurred, or at least when it was PR'ed to us - March 31, 2016. To stay on topic and not get sidetracked, let's only talk about the onsets of these interims (March 31, 2016), and not when the actual events (967, 1290, 1612) will occur.
I'm completely ignoring PYs, as we don't have enough info on them. Amarin said that the onset of 1612 will occur no later than EOY 2017. That is no more than 21 months for 968-1612. The question is: is 1290 the midway point (time-wise?
You say that entry criteria has changed in year 3. That is true, but IMO will not have much effect to differentiate the event rate in year 5 vs year 6. Perhaps year 2 vs year 6, but for the sake of argument we are only comparing years 5 and 6.
Based on the current available info, IMO we cannot assume anything other than what the company provided to us (tracking as expected and all the dates).
The only way I see that onset of 1290 NOT being the midway point is if the company is wanting to push it back slightly to allow few more events to occur, in case that they think it will be a close decision by DMC and those few events could make the difference.
My argument is that we DO know when the onset of 60% occurred, or at least when it was PR'ed to us - March 31, 2016. To stay on topic and not get sidetracked, let's only talk about the onsets of these interims (March 31, 2016), and not when the actual events (967, 1290, 1612) will occur.
I'm completely ignoring PYs, as we don't have enough info on them. Amarin said that the onset of 1612 will occur no later than EOY 2017. That is no more than 21 months for 968-1612. The question is: is 1290 the midway point (time-wise?
You say that entry criteria has changed in year 3. That is true, but IMO will not have much effect to differentiate the event rate in year 5 vs year 6. Perhaps year 2 vs year 6, but for the sake of argument we are only comparing years 5 and 6.
Based on the current available info, IMO we cannot assume anything other than what the company provided to us (tracking as expected and all the dates).
The only way I see that onset of 1290 NOT being the midway point is if the company is wanting to push it back slightly to allow few more events to occur, in case that they think it will be a close decision by DMC and those few events could make the difference.
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