V was superior the first time thru using ANCHOR as support in the MARINE submission. Now everybody is saying they have to look at ANCHOR again more thououghly AGAIN because its some new population of high TRI patients? T
They already know what ANCHOR did---they reviewed it in MARINE!. The question is what is the bug thats up the FDA @#$ on this that would require a meeting? iI has to be about efficacy and extrapolating to further positive results and that means an outcomes connection!