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| Alias Born | 11/07/2018 |
Wednesday, December 18, 2019 10:19:08 PM
I believe that your understanding of the results of Amarin's 1st Amendment win over the FDA is incorrect. If I'm recalling correctly, this win allows for Amarin to communicate factual details about Vascepa and results from studies, but only to medical professionals.
For instance, Amarin can send out an email containing the following information...
(c/o @greenday_bio on Twitter
The FDA label only says people with Trigs at and above 150 mg/dL. However, since Amarin is able to show that the 5-point MACE results from REDUCE-IT were consistent in the subgroup of people with Trigs below 150 mg/dL as they were with above 150, they can relay this information to doctors. They would not be able to include this on any direct-to-customer advertisements.
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