Amarin's not going to this meeting to argue Triglycerides, they're going to argue facts:
1) Marine Exclusivity withheld
2) Vascepa Exclusivity Delayed, Month over Month & USPTO denied the information needed from the FDA to extend the Patent on Vascepa. This is the first violation of Federal Regulatory guidelines.
3) John Fuson, was hired by GSK to defend Antitrust lawsuit 2005, Hired by the FDA to work with enforcement and DOJ 2007-2011, hired by C&M 2011 to help the firm "legally" extend the life of pharmaceutical products OWKA How to legally form an Antitrust against your competitors.
4) FDA accepts "shame Citizen Petition" from the above former FDA attorney. By no stretch of the imagination does this petition pass the smell test. Second violation of Federal Regulatory Guidelines.
5) CP delays exclusivity Month over Month for (Non public safety reasons, the only justified Regulatory reason for delay of a 505b2 application. The Marine application is NOT complete without the Hatch-Waxmann exclusivity determination. Third violation of Federal Regulations.
6) Accepts Anchor sNDA and provides "clean 74 day letter" clear intent to mislead Amarin into the Rigged Ad Com.
7) Ad Com rigged to achieve negative vote, with the intent to use to rescind Anchor. Ad a Com broke multiple guidances related to Ad Com procedure, used incomplete documents, and potentially conspired with public Ad Com members to DEFAME Anchor, REDUCEIT, Vadcepa, and Amarin.
8) 9 days later Rescind SPA, how many meetings took place in that 9 days....zero?
9) Amarin shareholder are decimated many will never recover financial loss due to the recklessness of 1-8
Amarin's going to the a Type A meeting to hold all accountable for their actions. This was a planned, coordinated, and illegal attempt to destroy a publicly traded company using and abusing the powers given to them through positions at the FDA.
It time to pay for the crimes committed.
