Amarin Corp Plc (AMRN)

[Biobillionair]

The FDA needs to define Omega 3 into 3 categories:
1) Mixed Omega's like Lovaza and Epanova
2) Isolated single agents Vascepa or other pure Omega concentrates
3) The ability to define combinations of concentrated agents like 50:50 EPA:DHA

The Lovaza CP I believe was requested to subvert Pronova patents. It could have been a Private generic company or Omthera. As I've previously stated Epanova treads on Lovaza patents and CP mentioned Lovaza's patents in last C&M comment. AZN and Omthera's 74 day letter is due at the end of next week. It's my opinion, it's not fileable due to patent infringements and the inability to get a patent. This might be the next binary Amarin event.

A refuse will have to be announced by AZN, as it's material.

(3) If FDA refuses to file the application, the agency will notify the applicant in writing and state the reason under paragraph (d) or (e) of this section for the refusal. If FDA refuses to file the application under paragraph (d) of this section, the applicant may request in writing within 30 days of the date of the agency's notification an informal conference with the agency about whether the agency should file the application. If, following the informal conference, the applicant requests that FDA file the application (with or without amendments to correct the deficiencies), the agency will file the application over protest under paragraph (a)(2) of this section, notify the applicant in writing, and review it as filed. If the application is filed over protest, the date of filing will be the date 60 days after the date the applicant requested the informal conference. The applicant need not resubmit a copy of an application that is filed over protest. If FDA refuses to file the application under paragraph (e) of this section, the applicant may amend the application and resubmit it, and the agency will make a determination under this section whether it may be filed.