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concapk

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concapk

Re: rafunrafun post# 115523

Wednesday, 10/04/2017 7:26:17 PM

Wednesday, October 04, 2017 7:26:17 PM

Post# of 427915
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.

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