Mellowmood77 Thursday, 09/19/19 07:41:16 PM Re: rafunrafun post# 215212 Post # of 219978 I don’t believe it’s in response to MRC’s petition, especially since it more specifically talks about ANDA’s. But maybe MRC’s CP was the straw that broke the camel’s back. Who knows! But the AGENDA sure matches the concerns MRC’s CP detailed: efficacy. Most likely the ADCOM will be bringing up detailed MA’s on how EPA works, meta analyses of other studies that also had LDL increases in placebo arms (uhhh Nissen’s EPANOVA?!), and other details that have yet been revealed (epa/aa levels etc). I am not worried about ADCOM. The fact of the matter is this: They might not be able to prove 100 percent that mineral oil didn’t inflate the results of the trial, BUT THEY CAN’T PROVE THAT IT DID EITHER. Now given the safety profile of Vascepa (water might be more dangerous), what seems like the most logical thing to do if a DDI study is warranted? Approve it INTERIM, or force millions of patients that can possibly benefit from EPA to wait on a life saving drug? Last ADCOM wasn’t unanimous. It was 7-2. Are we really to assume given the same voters, 3 of them wouldn’t approve after REDUCE-IT? Especially since almost all of them said they would like to wait for REDUCE-IT results? SINCE then: ADA, NLA, ACC, AHA, MAYO, and others have given endorsements one way or another. Will they go against them? No I am not worried even a little about the ADCOM. I’m 99% sure we will get approved. I’m just pissed we were forced into having one. Robert Smith of the last ADCOM said something to the effect that it should be approved now given the safety profile so that patients might benefit from effects that aren’t currently understood. I gave the exact quote a while ago in another post. What a smart human being.