Stop Being reasonable, doesn’t fit the mass hysteria going on. We’ll see if the conspiracy theorist have a foot to stand on by end of year, I don’t see any of it myself either but not an impossibility.
The cardio division misses dates more than anyone, up until the past few years FDA PR was almost always a few months late though the last few years almost always on time.
I think Adcom will be unanimous for expanded label, label gets expanded, what label is will be main question. MO will come up, will be discussed, Amarin has plenty of time to be ready for this,
This is an outcome trial, you would need a 6 year MO trial to see if it has same results without Vascepa on other side, not going to happen, a ST study on LDL or anything completely meaningless in terms of CV events so what else would they look at on the negative side? Not much. This is a once in 20 year change to SOC for at least a third of the population, the Adcom seems necessary, the timing I believe is a product of short staff and bad employees not some grand conspiracy to kill people because BP wants to buy Amarin cheaply or whatever the endgame is in the conspiracy theory, not sure I get what the endgame is in the conspiracy theory by the FDA.
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