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Re: None

Monday, 06/10/2019 11:39:10 PM

Monday, June 10, 2019 11:39:10 PM

Post# of 425800
I may be in the minority but I don't see the AdCom as really bad news. Sure I prefer not to have it, but having one doesn't bother me.

I keep seeing posts that we've already had one, for ANCHOR, but obviously RI wasn't discussed there.

What's there to discuss?

MO - I believe it's a non issue and doesn't need to be discussed... not because I'm biased but because it's moronic, for all previously discussed reasons.

TG on label - if Amarin requests 150, then there's no issue. If Amarin requests 135, could FDA want to have a discussion, since only 10% were? If Amarin wants to get feisty and request TG > 100 or better yet no TG, surely that will result in an AdCom?

But the main reason for the AdCom is the size of the label and the impact that this will have on the USA's #1 killer. Still doesn't answer: WTF are they going to talk about?

I honestly don't know, perhaps beurocracy being beurocracy: FDA wants others to tell them yes because the label is that big?

If nothing is announced by EOD tomorrow, I give 90% no AdCom.
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