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Tuesday, 06/11/2019 10:15:41 AM

Tuesday, June 11, 2019 10:15:41 AM

Post# of 428823
FDA label question. I guess it is time to start some due diligence related to FDA labeling. With Statins use increasing and guidelines seemingly changing regularly to increase those that are recommended to be on Statins combined with the fact a large percent of people stop taking Statins due to side effects is it possible for FDA label to have something like:

To be used as an add on to Statin use OR as a standalone for patients that cannot tolerate Statins.

Even adding some caveat With the possibility Amarin is to track success of those that can't tolerate Statins as compared to the RI placebo group and FDA can revisit that part of the label depending on future info received from this type of use.

If so is it possible many people that are captured under the wider guidelines for recommended Statins use would think, I am borderline, I don't want Statins, my doctor or I will agree I can't tolerate them and just give me some "V". Thus, perhaps, in some backward way we could get a de facto study of Vascepa without Statins? Though the main point is the sales potential of "V" could be higher than Statins due to the minimal side effects.

Which reminds me there needs to be some advertising tie in to the "V" in True Blood and how badly V was desired and needed. I have a whole commercial in my mind but if you never saw the show it's wasted LOL.

"human blood sustains life, vampire blood is life." just replace human blood with statins and vampire blood with Vascepa...

OK I digress there at the end.....HA
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