Amarin Corp Plc (AMRN)

[jfmcrr]

Adverse Events are complications, or conditions (events) which would not be considered part of the normal disease progression for the indication the trial is studying...

Note also that a track record exists for V in the general population; Marine and off label. The object of the exercise for the DSMB is not to understand everything for everybody but to keep the study on track in terms of safety. A minor incidence of diarrhea or nausea in a few subjects may be noted as typical and even a major crisis in someone with a severe fish allergy who somehow got through screening, though regrettable, would not be beyond the pale for the drug's track record.

These are not part of the disease progression but also not unknown or surprising for the drug. There are limits to the involvement of the Safety Crew in the ordinary course of affairs and that is hardly surprising in a double blind.