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$AMRN $AMRN Sunday School Class for Sunday, August 15, 2021CaptBeer, published August 15, 2021
Topic: It's time to Exercise our First Amendment Rights.
ABSTRACT:
Back in October 2013, the FDA ambushed Amarin in the infamous ADCOM meeting by moving the goal post of the ANCHOR Clinical Trial, and a few weeks later they rescinded the SPA, (which was basically an agreement to approve the 200-499 mg/dl new indication for VASCEPA®).
More than two years later (November 2015), a United States District Court ruled that Amarin may promote to healthcare professionals’ certain uses of Amarin's lead product, VASCEPA® (icosapent ethyl) capsules, that are not covered by current FDA-approved labeling for the drug so long as the promotion is “truthful and non-misleading”.
Can Amarin promote “truthful and non-misleading” information to HCP’s about VASCEPA® that are not covered by the current label?
Read all about it here:
https://drive.google.com/file/d/1EhKocfDnS1eDRW-u6AjLxX4-HwtPLf_x/view?usp=sharing
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