Amarin Corp Plc (AMRN)

[Biobillionair]

Pretty much correct IMO, however, Amarin filed a 505b2 for Marine & applied for 5 yr NCE. Partly what set the confusion in motion.

See these documents:

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000AdminCorres.pdf

It certainly doesn't excuse the no decision after a YEAR.

The problems:
1) Amarin changed application forms 505b1 to 505b2
2) The FDA had never defined Lovaza's active moeity or mechanism of action
3) Lovaza had no RLD until after Vascepa Approval
4)The FDA is corrupt, CDER is the by far the most corrupt of any government agency of any world government ever!
5) delay became intentially prolonged after the FALL due to ?? ... Prolonged further in February with the Citizens petition filed by one of CDER's former Attorneys who likely had details on Vascepa/Lovaza exclusivity issues. I wonder who hired him? The FDA should have never excepted a petition filed by a former colleague with inside information.

No f'n brainier...on 7-26-2012 the FDA approved Icosapent Ethyl, Vascepa for the treatment of Very high triglycerides. No other active ingredient, moeity, drug period was listed in the OB at this time of approval. By definition this is a NCE.

After approval the FDA had to retroactive Lovaza's history to define Vasecepa. They have harmed Amarin, Vascepa and Amarin shareholders in this process.

They need to wake the F'k up this week!

Williams