Replies to post #47406 on Amarin Corp Plc (AMRN)

[BioChica]

Agree, but NCE case allows Amarins legal team to test the waters. If the FDA does not respond in a timely manor regarding sNDA. Since the FDA claim to have begun work again on it! The fact that they have yet to provide any answers is questionable. Perhab's a judge will decide that Amarin has exhausted every option in the appeal process regarding sNDA with the FDA!

[invest2992]

I agree that the judge grants AMRN an NCE, the question in my mind is does he give us 2 year extension or 5 years from decision, a possibility given Sipes arguement saying there is nothing said re repairing wrong (and malicious) designation in the first instance.

[Biobillionair]

HD-

---"The Judge will rule in favor of Amarin re NCE and stick to the NCE issue only (no SPA, no ANCHOR, no etc. decision / advise / reference)."---

I'm not convinced Judge Moss can only stick to NCE issue, I think ruling in favor opens the questions: Why did the FDA take so long?, Why did they not follow their own past rulings?, and why did FDA create new policy...but still rule against Amarin?

These are all within the hearing minutes. The Judge will not throw up his hands, "I have no idea what the FDA was thinking nor do I care, ruling for the plaintiff."

Judge will not give the FDA an opportunity for an easy appeal, and will likely send a shot across the bow of DOJ legal with a firm ruling and referral for further charges.

BB