Raf: Are you being a blockhead or just you being you....
SPA'S are conditional contracts to begin with... as long as a company follows FDA proticals setup between the two and monitored for safety throughout... the REDUCE-IT study was already underway...
The ADCOM question was changed to produce a negative response .... the FDA changed from TRIG lowering to an add on to statins producing results that the cvot would show one way or another 4 years hence...the question wanted a solution on the spot, which could only be shown on REDUCE-IT RESULTS 4 YEARS LATER.