I agree 100%. Not to mention Amarin would probably want the label approval process with FDA to go as smooth as possible. Not worth aggravating FDA after successful RI. We all well know what FDA is capable of when it comes to approvals and ADCOM questions...
This week’s settlement agreement stipulates that “Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa…and such speech may not form the basis of a prosecution for misbranding.” However, Amarin “bears the responsibility, going forward, of assuring that its communications to doctors regarding off-label use of Vascepa remain truthful and non-misleading.” To this end, the agreement also provides a special procedure through 2020 in which FDA will give Amarin advance review for as many as two promotional communications annually about off-label uses of Vascepa. Moreover, the agreement establishes a specific process for resolving any concerns that FDA voices about those communications prior to the parties returning to court.
There is no stipulation in this agreement that this 1A Right extends only to doctors...
As far as the AMCHOR results...The germane aspect is only that V lowered trigs without raising LDL-C...I believe they are including that in their presentation which as far as I know is available on the internet for all to read...
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