Amarin Corp Plc (AMRN)

[HDGabor]

They need to add enough DHA to to raise the LDL level in trials from what 15% to 20.1% to avoid any infringement ....is roughly my take

Yes ... and get a new approved NDA, since based on the existing one they could not change Epanova.

The AZN / Epanova story is so interesting, promising to us.

Forbes (6/3/2014)
"Matthew: Do you have NCE (New Chemical Entity designation) on it?
Pascal: Not yet. The problem is because Amarin has launched a legal case. Basically, I don’t think we’ll know about the NCE status until that Amarin case is settled."
Bullshit (or he is not familiar with NCE). The legal case is not related to NCE and vica versa, it’s about patent.

Patent (662)
Agree with BB, AZN is not fighting the patent itself, they have two arguments:
1.) LDL-C increase is greater than 20%: it’s not good, since the patent cover both arm (compare to baseline or to placebo arm) and while the LDL-C increase was more than 20% within Epanova arm, it was less than 20% compared to placebo arm within Epanova study.
2.) The Epanova not on the market, the launch is not imminent (we do not know their exact launch plan since it was sealed): currently it’s true – maybe the Judge will drop the case based on it – however it will not an argument if they launch Epanova (and if they launch AMRN will file a new legal case immediatelly)

Launch of Epanova: Agree with BB, If AZN had intension to launch, they'd do it ASAP after May 5th approval, unless they think that AMRN’s patent is strong.