If the FDA really wants to get negative votes from the Adcom panel, they can always ask questions not covered by the R-IT SPA or by the sNDA...For example:
1. Do you definitely believe that Vascepa will be effective in causing a reduction in CVE in patients, not also on statins?
2. Do you definitely believe that Vascepa will be effective in causing a reduction in CVE in patients with Trigs of less than 70 mgm/ml
3. Do you definitely believe that Vascepa will be effective in diabetics without a history of a cardiovascular event and without any risk factors?
I hope this adversarial scenario never happens...as it did in the Anchor Adcom Ambush, in October 2013