Amarin Corp Plc (AMRN)

[HDGabor]

I do not know, whether laugh or cry: ’add-on study ... Efficacy is, of course, established by such studies only for the combination treatment’

You will never find out where I found it ….

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073139.pdf

JL / sts66: read the above doc (1) and this one also (2) – specially

7.2. Accessing Interim Data
7.2.1. DMC Recommendations to Terminate the Study
7.2.2. FDA Interaction with DMCs


http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm127073.pdf

‘double-blind (or double-masked), meaning that both subjects and investigators, as well as sponsor or investigator staff involved in the treatment or clinical evaluation of subjects, are unaware of each subject's assigned treatment.’ from (1)

Birzinho / Ajax133: Birzinho has right 150 (and later 200) is the minimum TG level, so we do not know exact TG of enrolled patients (except Thero’s statement ‘mean and medium baseline triglycerides in REDUCE-IT are north of 200'.)