I think you and I agree on the label issue..In this case I think my English is a little confusing..(poor English on my part)..My point is experts would understand in most cases the drug would be treating a chronic condition and would require long term (greater than 12 weeks) and likely indefinite use in degenerative processes..and this would be understood by doctors treating these conditions (eg. Atherosclerosis) regardless if the label did not specifically say (use for more than 12 weeks)..
The R-I trial ran for more than six years...and enrollees were required to continue taking Vascepa for the duration..It is interesting the generics bring in 12 weeks which was the duration of ANCHOR and MARINE..Trials designed to determine Vascepa's effects on blood markers, but not on the disease process...REDUCE-IT suggested meaningful clinical benefits only began to emerge (separation of the arms) at about a year of treatment; suggesting 12 weeks was too short to achieve any therapeutic benefit from the drug
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