What can the FDA say against it. Hmmm, no side effects and all benefits, we're going to have to think long and hard about the only drug in any category helping triglycerides that doesn't do anything AT ALL BAD TO ANYBODY. Yep, the market is sleeping.
Approval of Anchor is not based on how good the results of Anchor, is based on how Reduce It trial goes. That was AMRN and FDA deal.
Anchor trial has been finished a long time ago, why AMRN has to wait till to the end of Feb to submit sNDA? AMRN has to wait until Reduce It trial getting develop.
Literally AMRN is within 10 months of having Vascepa on market for a muti-billion dollar potential and the best anybody can say is "Approval might not be certain". Duh, approval isn't certain for anything but there has never been a blockbuster in waiting that has no side effects. Side effects are the bane of drugs. It's the drug, not the company, not the fish it came from, it's the finished product and what it does and Vascepa has ZERO side effects except for some joint pain in a few patients, which isn't really a side effect if the joints are getting better. Vascepa is an FDA panels wet dream, nothing ever easier to approve.