Amarin Corp Plc (AMRN)

[moonotaur]

I'd disagree about them being covered if another reason for the delay actually exists and they are hiding it

Ggwpq laid out three other instances where companies actually disclose the reason for delay. It's only three, but that has been the standard public company response for this type of PDUFA delay situation (no one else can site a situation where a company didn't disclose a reason...been discussed thoroughly over the last weeks on here).

Why would Amarin not be held to the standard if taken to court? Further, the delay reason is not part of ongoing discussions. It is a fact that has been determined and communicated at this point and time.

Very grey area here if a legal preceding would occur...one that I'm sure Amarin would want to avoid if possible. Therefore it seems to me that the only reason for delay was for scheduling an ADCOM (which AMRN disclosed in their PR). If that is the case, the onus is on the FDA to provide a reason as to why they couldn't get their act together and schedule the meeting sooner.