Replies to post #207559 on Amarin Corp Plc (AMRN)

[Mellowmood77]

I’m hoping number 2. But KCSVEN could easily be right as well and they didn’t want to announce a date because of scheduling constraints with ADCOM members.

When’s the last time you heard the FDA say “earliest time we can schedule.”

If ADCOM members won’t come Nov 14 (and honestly it’s tight, I don’t blame them if they don’t), then they will extend the ADCOM date again, and here we are back at Jan 2020.

The biggest mystery is why NOW and not schedule the adcom months earlier?

If it really is JT wanting a broader label than the original SNDA asked for, he completely F’d up. Should have filed 2 separate SNDA’s.

I’m 50/50 on number 1 or 2. But if it is number 1, I don’t think Nov 14 holds.

[MateoPaisa]

Do you remember Thero’s words yesterday when talking about being notified? Im not in a place to pull up the recording but how did he say he learned about the adcom? “We received notice”? Or “We learned that...”

[marzan]

Boozman/Raf et al', I talked to different regulatory feds in various regulatory agencies. Your Number 2 is what going on they said. Boozman, please dpn't do any funny thing. Wait for FDA's FR notice next week. They are going to surprise us with a label and going to go for Label Change to include Diabetes or no statin combo what not at the Adcom. Please hang on for your son and you friends and family. God bless all longs.