Excellent point Zip even if it is a done deal that the FDA have to approve as HDG suggests
One mitigating factor might be that the FDA, itself, was unbelieving that the Marine study could show that EPA could lower trigs in patients with over 500 mgms/dcl WITHOUT increasing LDL(and thereby lower the incidence of cardiovascular events)... At the Anchor Ad com the FDA all but directed the panelists to say they did not believe this either...the panelists then followed the lead of the FDA with their negative vote.
The LDL hypothesis has been alive and kicking with increasing momentum supported by statin LDL reduction data since the early 1990's.If they really believed the non-LDL increase piece they would have approved at ANCHOR. Point is they didn't believe it nor did the FDA believe that just lowering TG's was going to cut the mustard in reducing CV endpoints--hence the demand for R-IT. HK