Amarin Corp Plc (AMRN)

[OldYeller187]

Thanks BB, it’d be interesting to learn more there. Elisabeth is great, but she was only able to give me an excerpt from the recent earnings call, where they mention EU submission in 2019.

My big takeaway is the EU/EMA accelerated assesment process starts well in advance of actual submission, and is even sometimes discussed during clinical development, see below:

“Under the PRIME scheme launched in March 2016, it is now possible for applicants to receive confirmation during the clinical development phase that their medicine might potentially be eligible for accelerated assessment.”

Again, I asked IR if Amarin was engaged in PRIME, but they weren’t able to give me an answer there. This is why I think there is a chance they could know already. Either way, they aren’t saying :)