Replies to post #106907 on Amarin Corp Plc (AMRN)

[HDGabor]

BB-

SPA rules are based on law; once an agreement is reached it can not be changed because of opinion ... SPA is to prevent moving bar scheme

it can not be changed - FDA may rescind an SPA agreement ...
because of opinion - the division director determines ...
once an agreement is reached - after the trial has begun ...

The basis of your view - substantial scientific issue essential to rescind an SPA agreement - is false, you do not interpret the law correctly. It is B&W: "substantial scientific issue essential to determining the safety or efficacy of the product" ... means available science is not enough to determine the efficacy without any doubt.

Best,
G