Replies to post #210705 on Amarin Corp Plc (AMRN)

[Atom0aks]

Not being the company I would not have standing.

So you do not know whether this they can call an adcom anytime they want even if it delays things... is part of the statute?

As I mentioned in the previous post, Yes they can.

4.7 Obtain Expert Advice
The review team can seek expert advice at any time during the review. Advice can come from other FDA divisions or centers, through an Advisory Committee meeting or an internal Regulatory Briefing, or from a Special Government Employee (SGE) consultant. (See Guidance for Industry)

Source: https://www.fda.gov/media/78941/download