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Re: sts66 post# 21399

Tuesday, 11/12/2013 1:20:18 PM

Tuesday, November 12, 2013 1:20:18 PM

Post# of 426567
I want to know if Amarin knew the wording in advance….

Was the question that was put in the commission members packets exactly what was distributed to Amarin in the briefing document? If so, then someone at Amarin should be called out. Had they had the presence of mind(s?) to go through the documents with a fine tooth comb and discover that the wording was problematic, they would have contacted the FDA in advance of the meeting to either change it or request a postponement of the meeting (if that was possible).

I've spent most of my working career in real estate development and have been involved in the processing of hundreds of zoning/land use applications. Routine procedure is to get the staff report as soon as possible before the public hearing to see if the staff is going to recommend approval, denial or approval with conditions. And you always try to work with staff to iron out any issues so you aren't out there on the floor in front of the public arguing over stupid stuff. And if you can't work it out ahead of time, you ask for a continuation. I can't imagine that this process with the FDA is any different and that if Amarin had made that attempt (to change the wording or request a continuation) they would at least have had that on record supporting the argument here that the FDA was not willing to work with them.
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