Replies to post #47409 on Amarin Corp Plc (AMRN)

[BioChica]

Yes FDA could end up paying court cost's at a minimum!

[HDGabor]

century-

The #40 & #41 are "support" of NCE, aren't a damage claim.

40. Amarin devoted significant resources to developing the first FDA approved icosapent ethyl product with the reasonable expectation that its innovation and investment would be entitled to the protection afforded by new chemical entity exclusivity.

41. Amarin’s development program for Vascepa has included numerous investigations, including nonclinical studies; placebo-controlled, randomized, double-blind Phase 3 clinical trials; and a cardiovascular outcomes study. Among the studies conducted by Amarin were two nonclinical carcinogenicity studies that FDA requested on the ground that approval of a new chemical entity for a chronic use indication generally requires that carcinogenicity studies be conducted in two rodent species.

Bio-

paying court cost's at a minimum

I do not say it isn't possible, however Amarin did not fill this type of claim (meanwhile they did it in the ANDAs case -"WHEREFORE, Plaintiffs seek the following relief: ... F. Costs and expenses in this action; ...")

Perhab's a judge will decide that Amarin has exhausted every option in the appeal process regarding sNDA with the FDA!

Which one? Judge wasn't appointed to the issue, case isn't exist.

[Biobillionair]

If the Judge did a full damage assessment the FDA would end up paying for more than just court fees. Amarin's NCE damages started the day after approval without the exclusivity. The company never had the plan of going it alone. Not make the exclusivity determination until 18 Months post approval almost destroyed the company. The hearing covered the 18 month time lapse.

Is it possible Judge rules for Amarin, awards NCE then refers case to DOJ for criminal charges?---This is the reason why the FDA should have never allowed this to go this far---

When you look at all the arguments raised by the Judge in favor of Amarin, there's no why to rationalize a judgement in favor of FDA without leaving numerous appeal options open for Amarin. There's only one conclusion to make...the FDA made the wrong decision...but why?

If the Judge needs to answer 'the why', then this get's very bad for FDA. Will the Judge just throw his hands up in the air and say, "FDA just got this wrong, don't know why, it's seems pretty cut and dry and is inconsistent with past FDA rulings. Oh, well...guess FDA was just having a bad 18 Month streak when they just couldn't decide until they created a new policy."...If you read the transcript you'd realize this Judge is not going to let the reasons for the FDA decision to be unanswered.

BB