C......."AMARIN was, an is a small company required to run a 7000 modified to an 8000 CVOT study costing approx. $250/300 million.
This study called REDUCE-IT would take approx. 4 years to complete and that cost would be mitigated by sales from ANCHOR approval. The FDA knew that they would be harming AMARIN by rescinding the SPA, "THEY DIDN'T CARE".
IMO the FDA was guilty of extortion......They used the Anchor SPA as bait to extort from Amarin a R-IT study BEFORE(i.e. in return for) their considering Anchor). Then ,once the R-T study was established, the FDA pulled the rug out from Amarin at the Adcom, rescinded the Anchor SPA, and left Amarin for dead, hopefully to bury the evidence of their misdeeds.