Amarin Corp Plc (AMRN)

[HDGabor]

birzinho: I could not comment, it's a calculator

stangish,

DMC check the eff. and safety data on a quarterly basis. These data / results available for them only. DMC could to stop the study for safety reason ANYTIME and they could propose to the sponsor to stop the study ANYTIME.

'We recommend that any part of the interim report to the DMC that includes comparative effectiveness and safety data presented by study group, whether coded or completely unblinded, be available only to DMC members during the course of the trial, including any follow-up period—that is, until the trial is completed and the blind is broken for the sponsor and investigators.'

'the interim analyses prior to the first analysis of unblinded data to develop a template for the interim reports.'

read this:

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