Replies to post #192781 on Amarin Corp Plc (AMRN)

[north40000]

I wonder whether the data and other pages from previous Vascepa trials like Marine and Anchor are included in that 5 million? They are in archive with FDA but have current review team actually read those pages from long ago?

[OldYeller187]

MP, nice DD and thanks for sharing this.

At face value it makes sense. But personally I have never heard of this before as a rate limiter in getting PR. I also asked a friend who interacts directly w/ FDA and he said the same.

Doesn’t mean it’s not true. But very likely Elisabeth is just going off information from the internal team at Amarin. That may be their hunch, but nobody knows for sure until FDA communicates the decision.

Interesting times!

[oneragman]

Mateo, We know for certain Health Canada is giving a PR with basically the same data packet. I would think the vastly superior resources of the FDA can handle it.