Replies to post #52275 on Amarin Corp Plc (AMRN)

[rafunrafun]

This is big brother at it's finest. The only way FDA can win this is if the judge belongs to a communist party. Their entire argument revolves about that if AMRN is allowed to distribute this info, this would undermine the entire regulatory PROCESS. If we have such incompetent agency running the PROCESS, then fck the PROCESS!

FDA thinks that they are better suited in making a decision of whether a patient could take the drug better than a doctor -WTF?

It's interesting how they put everything on the table - adcom, jelis, etc, as if though they're taking a pre-emptive strike against AMRN.

[biowreck]

It's definitely a long read, perhaps Janet is hoping the judge will fall asleep reading this primarily boilerplate paper describing the duties of the FDA and it's challenging role in protecting the public from the bad guys...( meanwhile I'm thinking about all the bad drugs the FDA allowed the public to consume).
I have to laugh when they emphasize substantial scientific evidence needed in the approval process, yet the studies they cited as a reason to reject anchor are highly questionable substantial science. Furthermore, it's lame on their her part to emphasize the safety aspect in all drug approvals, when in fact this drugs safety profile is one of the best I've ever encountered. But it does appear that she is focusing on reduce it not being completed by Amarin if Amarin was given anchor approval or win the lawsuit.

So I say to Janet, then you wouldn't object to a contract between Amarin and the FDA much like anchor spa that would require reduce it to complete while an expanded label for the anchor target population is allowed?

Of course the idea of some body reneging on a contract much like the.FDA did might leave her squeamish....