Replies to post #105504 on Amarin Corp Plc (AMRN)

[rosemountbomber]

Thanks Sam, looks like a good report. Here is the meat concerning R-I:

"Consistent with the trial design, Amarin continues to believe that the REDUCE-IT study is most likely to continue to completion of 100% of the target events. We surmise this because the efficacy requirements detailed to the DMC for early study stoppage after the 80% interim assessment are high. Unlike the data analysis at the end of the study, the interim analysis and review by the DMC also includes robustness thresholds for certain secondary endpoints. There are potential statistical advantages for the study to run to its full term. "

Would love to know what the "efficacy requirements detailed to the DMC for early study stoppage after the 80% interim assessment are high" specifically are. Obviously the statistical advantages at the end of the study would be the higher p value, but other than robustness of the certain secondary endpoints wonder what the primary endpoint efficacy targets were given to the DMC for stoppage.

[jessellivermore]

Sam(I am)

Sam you are and we are all thankful of that..

Wonderful report...All is well..Looks like R=I will run to completion which is disappointing because of the delay..But IMO it is the best thing for the company, the study and ultimately those of us that are long...

R=I embarks into new territory and goes against the dogma of the current cardiology inquisition which places statins at the center of the universe..We can expect resistance. It is essential we follow the rules and do not stray off the path..This means taking advantage of every last minute of the trial...Time as well as events is very important in these trials..Truncating the trial (halting the trial at 80%) deprives us of the very late period which puts most of the enrollees over the four years in the trial. The final time period (80% to completion) is where we should see the most dramatic differences in event rates between the two arms..

I believe the company understands this and doubt the company will halt the trial even if all points are met...

JMO...:">) JL