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Msg  66853 of 66861  at  11/15/2018 7:05:20 PM  by


 In response to msg 66852 by  bbyrdfree
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Re: Consider buying ALB - too much hype over nuttin

from someone that attended the AHA meeting last Saturday.


Jan D'Alvise
I just wanted to clarify what Pierre said earlier that we're using cornstarch as our placebo in trilogy and again that's a commonly used placebo it's well known to be an inert recipient [ph] and regarding the REDUCE-IT while there was a slight response seen in the placebo group in REDUCE-IT we believe as do I think many key opinion leaders who have commented since the American Heart Association meeting that it was not enough to question the overall really strong 25% cardiovascular outcome benefits that were observed and also keep in mind that the FDA approved the REDUCE-IT protocol using mineral oil after they saw the same placebo effects with mineral oil in Amarin's marine and anchor studies and I think you know furthermore it's important to keep in mind the JEALOUS [ph] study which was conducted with output placebo just versus standard of care and yet there was a big benefit for the same popular population of patients that started the trial with elevated triglycerides. So Pierre I don't know if you want to add anything to that?
Pierre Lemieux
Yes, I mean I was at the American Heart and heard the REDUCE-IT trial outcome presentation four times each time with a different key opinion leader presenting the data. None of them are concerned about this slight placebo effect. First of all that they've seen it before and not only with mineral oil but also with corn oil you know the same placebo has been used by other companies. So I mean it's part of the design of the trials that's why you're using a placebo to give you an idea of the natural variation in a population being followed for five years. So none of the key opinion leaders were actually bothered by that and like John said I mean even though there was a slight I would say effect on the placebo it would never explain that 25% reduction in cardiovascular risk. So I it might be slightly overestimated but you know not enough to explain this.
So obviously Amarin is really I mean that they are positioning themselves is talk about the fact that EPA brings a variety of different benefits and so I think fortunately there's a background noise and it's been over I think there's an overreaction with regard to this placebo people effect and it will correct itself at some point so that that's what it is as we speak.
Unidentified Analyst"

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