Replies to post #100381 on Amarin Corp Plc (AMRN)

[rafunrafun]

I have not heard that events are being reviewed quarterly. If you could please provide me with a citation of that, I would greatly appreciate it.

It is just a guess but I think the announcement on March 31, 2016 was just a coincidence, with it being the last day of the first quarter. I just can't imagine with this being such an expensive study, that they would only get updated of events on quarterly basis.

[HDGabor]

k-

DMC:
- "met in closed session to look at and discuss unblinded safety data on an approximately quarterly basis" means: in every quarter, but it is not necessarily at the end of the quarter and time between two meetings could be 2 or 4 months also, not 3 only AND it is about safety only ("the upcoming interim analysis will represent the first review of unblinded efficacy data by the DMC." - Q1 2016 CC)
- interpret (analyze) the Statistical report (analysis) at 1st IA, 2nd IA and @ final
- does not review any event !!!

The occurrences reviewed by other Committee and if they adjudicate the occurrence, it will become an event. Q4 2015 CC:

Throughout the course of the study, all potential cardiovascular events are monitored, recorded and ultimately verified or as we refer to it adjudicated by a blinded review committee through a multiple step process to determine whether such potential events meet the studies pre-specified criteria and are formally considered primary events for the purpose of interim and final analysis.

What this means is that over any given period, we may have a 100 or so potential primary events that are working their way through the funnel of being formally adjudicated and confirmed by the blinded clinical event committee or CEC. As you would expect this process of verifying events is time consuming with adjudication of those events often taking multiple months and only a portion of potential events confirmed as primary events.

Of course this far into the study, we’ve a fairly good sense for approximately what percentage of potential events eventually get confirmed and believe we can estimate fairly accurately how many events have accrued.

Based on historical data, our current estimates suggest we will have accrued approximately 60% or approximately 967 of the target aggregate number of primary cardiovascular events in the first half of 2016. However, we will not have confirmation by way of official adjudication of this event until well after the event has occurred.

We do not have an information how frequently they report to the Co., but more likely it is more frequent then quarterly.

Best,
G