Replies to post #208447 on Amarin Corp Plc (AMRN)

[james murphy]

Bio you have done a great job on the board and worked endlessly.But you are a thorn in her side and she never gave you you any info over the years but just one liner replies.Let Amrn work wouldcock.best of luck in the future

[Atom0aks]

Do you have an example of an AdCom that occurred after a PDUFA action date? My research has only shown extensions (see Xeris Pharmaceuticals, Acorda, and Sage Therapeutics), which is inline with FDA goals outlined here (https://www.fda.gov/media/99140/download). Keep in mind, the document may only outline goals and may not be SOP. I will concede, however, that an AdCom this late in the cycle is contrary to said goals of convening AC meetings 6 weeks prior to the PDUFA goal date for priority reviews.

[Invest83838]

BB, Hopefully FDA Grants ANCHOR Approval Soon


and this ADCOM is only for REDUCE-IT


Because at the ANCHOR ADCOM ambush,

FDA indicated that they liked the results of ANCHOR

but want REDUCE-IT results before they granted ANCHOR approval

[ziploc_1]

BB..."It’s totally acceptable for the FDA to hold an Ad Com after PDUFA date and “some” label expansion."

This makes a lot of sense...the rational for the Adcom is to give expert advice to the FDA on the decision to approve or disapprove a drug...there is an abundance of information in the public domain to support approval of the sNDA of R-IT...what remains are label questions, such as the role of triglyceride levels and statins...these questions can provide a proper focus for discussion at an an Adcom after the PDUFA date.