Amarin Corp Plc (AMRN)

[HDGabor]

Agreed. Now (on or before Aug 8) or R-IT will be approved based on interim result or on DMC decision.

Pros:
- With rare exception, FDA has historically considered granting approval for lipid-altering drugs based on favorable changes in the lipid profile
- TG as a valid marker confirmed by 2 studies
- LDL-P as a valid marker confirmed by 1 study
- it’s safe
- it has not any side effect
- unworldliness of Congressional Record and the 1997 PDUFA Goals Letter
- Senate’s / House’s query

Cons:
- drugs basically approved based on hard outcome
- it was rescinded