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Biobillionair

11/01/14 10:42 AM

#37685 RE: jessellivermore #37683

Science has nothing to do with the treatment of Amarin.

Policy high jacked Amarin at the Marine level. After Anchor results the FDA assumed Amarin would get bought out. It obviously didn't, the FDA wasn't keen on small Bio having a big indication...CDER Medical Policy was tasked to sloooooow Amarin. IMO these plans started formulating in 2011 when the FDA started waffling on NCE. Somewhere in here the Biosimulars Policy is injected...I don't know how yet. (Possible BP interference at this stage)

What makes this look so bad is the time it's taking to correct the issues, CDER acted fairly quickly in rearranging staff and getting rid of those that drove the Policy train over Amarin.

The FDA has to somehow answer EPADI CP without admitting Policy makers destroyed a publicly traded company to advance an agenda. Hopefully Grail Sipes can get it done and somehow rebuild what negligent CDER Policy makers destroyed.

I know it seems impossible...but on 10-16-2014 Amarin has an Army of suppliers and capsulators now online.
Bottom of page, this is an updated label on 10-23-2014. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9c1a2828-1583-4414-ab22-a60480e8e508


We should see an answer on the CP before Christmas Holiday.

BB