Amarin Corp Plc (AMRN)

[SovereignNinja5]

Amarin the entity has never discussed the new methods of use and reformulation patent. That is 100% retail investigated. Under Karim and Per they were the ones going down the Fixed Dose Combination path and stated it in a 10K/Q. Some work had been done but that direction is/was a low hanging fruit path which is why those two idiots chose it. There is a specific FDA guidance for it (FDC) and it’s not a proper path for lifecycle management of a lost patent and gives you minimum in return. Holt/Sarissa stopped this immediately. Sarissa and his team with the CSO knows the FDA codified regulations as well as the patent path which is probably why he declared the asset as undervalued and has quietly executed it. The rub is if they’ve done the required work for the submission once they get the patent in hand. If they met with the FDA in a formal meeting prior and there was a mapped out path between the two then this gets better. My assumption is they have which is why they had a citizens petition filed at FDA for fenofibrates. They still need and want the USA market so they can keep this model with the PBM’s. Having the CVD IFU and a new method of use/formulation changes the infringement game. It also changes the generic game. The plan with the step therapy and triglycerides is another game because the use of an authorized generic they keep talking about as a potential use is another bucket of opportunity.