Amarin Corp Plc (AMRN)

[Biobillionair]

Moo- Agree JT was angry 8-8.

I understand the late Ad Com...The label population is huge....What I don’t understand is reason given to Amarin to delay PDUFA? Amarin will not state reason FDA gave to them regarding 3 month PDUFA delay?

The FDA can not give a 3 month PDUFA delay without providing the sponsors with a reason. The sponsor deserves a chance to reply to reason.

Perhaps MRC Citizen Petition is reason for delayed PDUFA and Ad Com and Amarin’s response to MRC was not good enough for the FDA? The FDA could carry ongoing doubts about efficacy after reading and attempting to respond to MRC Citizen Petition.

It would certainly alienate the FDA for Amarin to state the FDA cannot respond to Citizen Petition without an Ad Com.....

Thoughts?

BB