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Sunday, November 17, 2019 11:19:00 AM
ADCOM revealed that the panel did nod read the DOC'S or do any DD on VASCEPA .... They completely failed to ask AMARIN about the MOA throughout the proceedings...this board is so far ahead of the medical community...
JT is playing CHESS with the FDA..... He is proceeding with four steps to accomplish his goal.... STEP 1 just get the indication approved at ADCOM ...brought the right people to deal with briefing DOC'S ... 16-0 favorable result.... STEP 2 set up late breaking EVAPORATE TRIAL results at AHA conference establishing MOA... high trig's biomarker with lowering systematic inflation as method of action producing outstanding REDUCE-IT results..... STEP 3 work on labeling for PRIMARY/SECONDARY before PDUFA date of DEC.28..... probably a week before CHRISTMAS, so that FDA employees can go on vacation knowing they did something positive for the AMERICAN public..... the SAFETY profile allows FDA to cross all boundaries for this indication.... STEP 4 settle the generic lawsuit before end of 2019 keeping the PATENTS impenetrable ......
Complete the 4 STEPS and start selling VASCEPA to the masses ( volume over price )....
CHESS ( thinking-plan of action ) versus CHECKERS ( one move at a time )
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