Replies to post #198616 on Amarin Corp Plc (AMRN)

[KCSVEN]

Doesn't each department within CDER determine the ADCOM. So if Division of Neurology has an Adcom scheduled it has no bearing on the Division of Cardiovascular and Renal Products so I would think as long as the Division of Cardiovascular and Renal Products has set one for August 7 then they would be chronological and will not schedule one before that but if it's another division I don't think that would apply.

Maybe I'm wrong on how they schedule but I swear I read it is by department somewhere but will defer to someone with better knowledge/memory if they have better info.

[Biobillionair]

RAF-The earliest the FDA could schedule an Ad Com now for anything is 55 days from 6-28 or 8-22-2019. FDA must give sponsors a 55 day notice.

In addition to the above an Ad Com for Vascepa must take place 6 weeks before assigned PDUFA date for Amarin this date is 8-17.

Obviously an Ad Com can not be scheduled for 8-17, it doesn’t provide the sponsor a 55 day notice.

Technically the window is closed for Ad Coms with a PDUFA date as close as Amarin...the FDA can however delay PDUFA date, but this would obviously be a huge issue for FDA.

So why didn’t the FDA communicate with Amarin? Because there’s bad blood between the two due to past legal issues.

I have requested an explanation yesterday, got nothing.

Today I requested the Senate HELP send a direct letter to Dr. Woodcock to clarify why PDUFA goal dates are being arbitrarily ignored regarding Vascepa application.

BB