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Re: rafunrafun post# 213036

Friday, 09/06/2019 7:42:55 PM

Friday, September 06, 2019 7:42:55 PM

Post# of 426709
The FDA misses 20% of PDUFA goal dates. So they are already incompetent.

Actually I think scheduling an adcom for this drug makes them look the MOST incompetent.

The adcom panel is there to vote on possibly the worlds safest prescription drug, with unprecedented efficacy results.

I can imagine them constantly checking their watches and thinking, “can I vote yes already?? Why am I here?? Why was this adcom scheduled?” This should be embarrassing for the FDA.

I stated after May 29th because I don’t think it would make much sense to know you’re going to delay the PDUFA and then assign priority review.

Anyway I don’t believe they asked for data. I believe it’s more likely the second scenario in my previous post and no one will ever know why the FDA decided on the late adcom unless it comes up in FOIA later.

What I DO know is after approval there definitely needs to be an Amarin investor party in Vegas. Raf I know you’re down, anyone else?





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