Amarin Corp Plc (AMRN)

[AVII77]

How many more events do you stats guys think occurred between 3/31 and 7/31?

Rough numbers

8000 patients
5%/year event rate

That's 400 events/year

So, in the 4 months you note above that's 133 events

Plus the 967 up to 3/31 and you have a rough estimate of 1100 events

That's 68% of the planned 1612 events.

If indeed correct, rather than 0.0076 as the critical p-value, the 68% information fraction critical p-value will be 0.0124

With 1100 events, that p value would be achieved with a 14% RRR

14% RRR is good enough to be declared stat sig, but perhaps not good enough for approval and adoption/acceptance from the cardiac community. But, for reference, at 1100 events, a 18% RRR would hit a p value of 0.001 on the primary.

Most EBM cardiac guys think 0.001 is pretty compelling.

Also, that would leave 190 events until the 80% interim. Using the same rough approximations, that's 6 months from 7/31 or late Jan/early Feb of next year for the event that triggers the second interim at 80%.

To be clear, I'm expecting far more than 1100 primary event components at this first interim. But just 1100 First occurrences of Primary events.