Amarin Corp Plc (AMRN)

[HDGabor]

I agree w your appeal process view (w small correction: July- Jenkins / October - Woodcock / January Hamburg).

BB did not said the process OFFICALY reached Hamburg level. He said the case on her desk and for me it's realistic as I wrote "„If Hamburg does not want to deal with this issue, maybe we get positive answer from Woodcock by October. (if Woodcock has the same attitude, Dr. Jenkins level will be reinstate the SPA by end of July)” and "I guess we will get the final answer from FDA on OND level (if it will be no we have to go through the next 2 level before the court but it will be technical steps only.)" - btw: it' not unusual in the normal business course also

From CC: “We would get a response from Dr. Jenkins and if to that we have a negative response and we have the ability to appeal to next level, which is Janet Woodcock and then up to the Commissioner from there.”

R-IT SPA: it’s not unusual to modify an existing SPA (as I remember the ANCHOR SPA were modified also). and you have right, it could be changed only by mutual agreement and yes I could not think that the design (90% power, 15% efficiency, median 4 years follow-up) could / should be change, ONLY try to set additional (earlier) or new milestone (interim result at x% of events instead of 60%).