Amarin Corp Plc (AMRN)

[Biobillionair]

THE FDA CAN'T BREAK THE ANCHOR SPA

The committee went on record to state it met SPA safety and efficasy. The FDA requested the comittee go on record and read the tea leaves of REDUCEIT. SPA agreement per FDA can only be broken for safety reasons.

"Agency will not later alter its perspective on the issues of design, execution, or analyses unless public health concerns unrecognized at the time of protocol assessment under this process are evident."

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf

The only "public health concerns" I see, are if the FDA doesn't follow the Lipid guidelines of AACE. They have expressivly added Trigs should be considered a CHD risk factor. Agressive treatment at levels of 150. It was poor science not to have this represented better. The document is here:
https://www.aace.com/publications/algorithm

In both the consensus statement and Diabetic treatment guidelines is specifically recommends agressive treatment for dyslipdemia and CAD type 2 DM. This treatment includes Omega 3 EE, and in the statement it guarded against DHA containg Omega 3's.

The FDA would be very unwise to change the bar because of failed studies that include a completely separate drug.