Replies to post #31228 on Amarin Corp Plc (AMRN)

[James364202]

KIWI, http://epadruginitiative.com/files/JELIS_Incremental_Effects_of_EPA_in_Secondary_Prevention_of_CV_Events_2009.pdf
On page 5, figure 4, the on treatment LDL of both groups was 130. It would appear both groups at start of study were not on statins, but Pravastatin 10mg or Simvastatin 5mg brought both groups down 27% to 130 LDL. Agree, 130 is not as good as less than 100, but it's a lot better than 178.
Also of note, after 4.6 years of study, MCE were brought down 23% in treatment with EPA group. I hope DMC for R-It are also monitoring subgroup low HDL and high tri as they had 53% reduction in JELIS.

[HDGabor]

I found these:

Development of Therapeutics for Heart Failure
Stopping Randomized Trials Early for Benefit and Estimation of Treatment Effects

- Every long-term trial has a interim analysis and a stopping guideline.
- DMC could recommends to stop the trial
- Decision is company's responsibility
- Bassler et al rather arbitrarily suggest that the threshold should be 500 events

I don't know that the stopping guideline is for the interim analysis only or for the entire duration of the trial, so could be applied anytime.

What's your thought?