I agree mostly, always thought an Adcom would happen until they took so long without announcing one. I’m not sure the size of population is a determining factor or not, how many drugs have ever been in front of FDA that had such a large population in the first place so hard to say that this population size is always an Adcom since so few drugs have this population. Common sense says it makes sense but hard to say historically it’s always the case.
It’s unfortunate Amarin does not feel like letting shareholders know what label they are requesting or anything regarding label discussion, that would help a lot in so many ways.
The Adcom discussion will be wide, about alot of things. Very curious to see what the voting questions entail, though long wait for that info.
Mainly I do not see true and real evidence that MO had a material effect or any other item makes the RI study invalid. There are clearly MO questions out there and FDA was concerned about it in anchor but science will make ADCOM members comfortable with that and FDA won’t have much to counter,
If there is a vote on “Did MO effect results” It would be an incredibly interesting ADCOM, if that is discussed but not voted on then the ADCOM is going to disappoint in term of being remotely controversial or interesting.
We have many peer reviews on RI and all conclude there is a benefit. ADCOM members will all have same conclusion and expect unanimous vote for approval but unsure on label since Amarin won’t share enough info.
IMO.
I think many of us have invested a lot of money, emotion and time and just want expanded label approved already and the frustration of another delay has been hard. We will all be glad to get to the FDA decision day, I expect we can all be happy then, definitely earned it.
