Amarin Corp Plc (AMRN)

[HDGabor]

They requested – and FDA agreed – the modification of R-IT’s SPA in May 2013. They increased the min. criteria for TG from 150 to 200 mg / dl. Around this time, the enrolled patients was app. 5,000 with a median 22 months follow-up.

The reason of the modification was the lower than expected event rate. DMC has a meeting in every quarter and they could see – and nobody else – the unblinded details. AMRN is receiving blinded, overall data / info (active and placebo arm together, not separated) on a quarterly basis. AMRN does not know the exact reason behind the rate difference: (1) lower placebo rate or (2) significantly higher eff.%

btw: As the lower than expected event rate was overall rate, I more confident that the planned 5,2% was also overall, so with 15% eff. the placebo was planned as 5,62% and active arm as 4,78%.