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Re: eightisenough post# 220830

Thursday, 10/24/2019 7:15:03 AM

Thursday, October 24, 2019 7:15:03 AM

Post# of 425888
8-I’ve had extensive discussions with AMARIN/FDA regarding Ad Com, we’ll have to wait for briefing documents to see what topics are relevant. I have encouraged AMARIN to share the “final briefing” documents with investors prior to the FDA posting the documents 2 days before the meeting.

I first requested the FDA post the documents the same time final documents are sent to AMARIN & Committee, but Woodcock states they will “follow procedure”.

Amarin will not commit on whether they will post the documents. I claim the documents are material and unsecured via FDA distribution means.... AMARIN insists the FDA will not want them to share the materials...I claim the FDA can’t tell AMARIN to withhold material information...and this will cause issues post release and after Ad Com.

I have also nailed Woodcock down on the meaning of “final documents”... vast agenda topics are not permitted so if the briefing materials contains significant issues AMARIN needs to scheduled a type A meeting prior to Ad Com so I don’t have to listen to another ANCHOR SPA debacle. Woodcock states the, “final documents” used at Ad Com, will only contain spelling/grammar corrections....

All this reminds me to review the SPA guidelines with Woodcock prior to the end of the week.....

BB

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