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slimhere

07/11/19 9:14 AM

#201017 RE: jessellivermore #201003

JL, I think that the FDA will site the 2013 AdCom and will actually use Mary Park's famous question! I'll remind you, I listened to this meeting with Adam Feuerstein being the moderator, when Mary asked her famous question, my wife called the results, she claimed that there isn't a doctor alive that is going to say that they know something that they only believe to be true (she was wrong, two voted, yes) however, all no votes on the panel requested the trail continue to completion. It has.

I agree with you that the FDA doesn't hold anything against Amarin, nor do they want to discuss the 2013 screw up, so (IMO) they PR label expansion while discussing how the R-I results have more than answered all the questions/concerns of the 2013 panelists. A well worded PR will make it look like there was an AdCom (which there was).

Like Kev, I believe one morning you'll wake up and find this PR, this will happen (IMO) long before September 28; so, in the fullness of time, we'll know if I'm right.