Amarin Corp Plc (AMRN)

[iwfal]

When I am talking about the RWD, I only refer to it in the context of safety. The DMC meets quarterly on the roughly 8000 RI patients. RWD data is accumulated daily on more then 10 times the number of patients. If there were issues of bleeding, don't you think that would have already been reported to the FDA and the FDA would have acted?

Nothing magic about statistics with regard to safety. Same computational techniques, same biases, same powering issues (but worse because of multiplicity and generally less uniformly adjudicated). So the same limitations apply - observational studies (and their comparison to historicals) have very poor ability to see hazards unless they are extreme. So, yeah, there is a case that it rules out 3:1 bleeding risk. Beyond that, ... probably not much. But you might try looking at the new FDA website - but good luck comparing it to historicals.