Replies to post #214914 on Amarin Corp Plc (AMRN)

[Biobillionair]

Gg- I agree. There must be a reason, either FDA has none (PDUFA will not be delayed), Amarin doesn't have reason, or Amarin is WITHHOLDING reason.

Until we get reason I assume Amarin is not witholding information and FDA has no reason.

No PDUFA delay IMO.

BB

[Atom0aks]

BB, we should be on the look out for a press release soon from AMRN regarding a formal PDUFA delay with explanation.

I don't think they will be putting out a press release based on the fact that it would not contain any new information from their 8 Aug 2019 press release (hyperlink) and they have already filed a Form 8-K on 12 Sep 2019 regarding the extension (see post #214911).

[moonotaur]

How quickly did those notices from the companies come out after they were notified by the FDA?

Six days have now passed since Amarin's 8K notifying investors of the delay...seems like this is a completely different situation.

[sts66]

Every one of those delays was because enough new info was asked for and received that FDA considered it to be an amendment to the NDA or sNDA - if that's what happened to AMRN I believe they would have said it in their PR - I really don't think FDA has told them why they called for an AC so late and delayed the PDUFA by 3 months.