Tuesday, March 14, 2017 11:07:59 AM
New theory about timing of the 80% onset, as first suggested by HD* and why...
60% onset - March 31, 2016.
100% onset (projected) - EOY 2017.
348 days have passed since the 60% onset.
292 days remain until the latest projected 100% onset.
At least 28 days past the midway point and the 80% onset has not been announced yet.
If the definition of the 'onset' has not changed, IMO it is impossible that the 80% will occur so far past the midway point, so something has to give:
1) 100% onset will be postponed to 2018.
2)* Definition of 'onset' has changed. At 60%, it was: after the sum of 'events' & 'occurrences that are in queue pending adjudication and will become events' reaches >967. For example, by March 31, 2016, 940 were already adjudicated as events, 100 were in a queue being adjudicated (based on history, 50% of adjudicated occurences become events). So at that point, Amarin were certain about 940 and felt comfortable that they will have +50, totaling 990, so they announced the onset at that point.
At the 80%, the definition of 'onset' was changed from the aforementioned to after it reaches 1290 adjudicated events, period. The difference it is announced after occurrences in the queue become adjudicated and reach the 1290 number. So for example, as of today, 1260 events were adjudicated and 100 are in the queue (50% of which typically become events), Amarin WILL NOT begin the 80% process interim they confirm that at least 1290 events are adjudicated - this could delay the onset by 2-3 months. Why do this?
Multitude of possibilities, perhaps they learned something during the 1st IA process? But I think the most likeliest is that they are confident in stopping at 80% and are wanting to get in as many events as possible. They rather delay the 80% process by 2-3 months and get 70-100 more events rather than wait 9 more months and do another analysis, which is expensive and time consuming.
JMO.
60% onset - March 31, 2016.
100% onset (projected) - EOY 2017.
348 days have passed since the 60% onset.
292 days remain until the latest projected 100% onset.
At least 28 days past the midway point and the 80% onset has not been announced yet.
If the definition of the 'onset' has not changed, IMO it is impossible that the 80% will occur so far past the midway point, so something has to give:
1) 100% onset will be postponed to 2018.
2)* Definition of 'onset' has changed. At 60%, it was: after the sum of 'events' & 'occurrences that are in queue pending adjudication and will become events' reaches >967. For example, by March 31, 2016, 940 were already adjudicated as events, 100 were in a queue being adjudicated (based on history, 50% of adjudicated occurences become events). So at that point, Amarin were certain about 940 and felt comfortable that they will have +50, totaling 990, so they announced the onset at that point.
At the 80%, the definition of 'onset' was changed from the aforementioned to after it reaches 1290 adjudicated events, period. The difference it is announced after occurrences in the queue become adjudicated and reach the 1290 number. So for example, as of today, 1260 events were adjudicated and 100 are in the queue (50% of which typically become events), Amarin WILL NOT begin the 80% process interim they confirm that at least 1290 events are adjudicated - this could delay the onset by 2-3 months. Why do this?
Multitude of possibilities, perhaps they learned something during the 1st IA process? But I think the most likeliest is that they are confident in stopping at 80% and are wanting to get in as many events as possible. They rather delay the 80% process by 2-3 months and get 70-100 more events rather than wait 9 more months and do another analysis, which is expensive and time consuming.
JMO.
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