Amarin Corp Plc (AMRN)

[Biobillionair]

Why "Kay's letter" is a BFD:

Under 35 USC 156(g) Vascepa meets the guidelines for a patent extension. In the USPTO's scientific eye, Icosapent Ethyl (Vascepa) has never been approved before by the FDA. This is a NCE definition. After the USPTO reviewed both Vascepa's and Lovaza's label they are willing to grant an extension.

This is a legally admissible document as is Amarin's dilution prospectus admitting material harm with lack of FDA exclusivity decision. Both these documents together provide more than circumstantial evidence to put CDER in front of a Senate Committee trying to explain many issues I've already posted, some of which may lead to individual criminal prosecution and Civil liability. If BP involvement can be proven this will lead to more than just Amarin seeking monetary retribution. (Who hired an Ex FDA attorney to file a citizen petition? How could the FDA even except a petition form someone with likely first hand knowledge into Vascepa's confidential review information?

I have given them enough time and "communication". Monday I will start this process if the OB is now anything but NCE for Vascepa. Prior to today I would except NME, but not after the USPTO letter. Ms. Behr, the neutral CDER Ombudsman, could persuade me to wait if she ever returned my phone calls.

Williams