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Re: Invest83838 post# 211504

Wednesday, 08/28/2019 9:25:15 AM

Wednesday, August 28, 2019 9:25:15 AM

Post# of 425623
That would be quite a stretch.

Amarin should be receiving some clarification this week if the Nov 14th date holds.

For open advisory committee meetings that involve sponsor-prepared briefing materials, approximately 55 business days before the meeting is scheduled to occur, FDA intends to notify a sponsor that an advisory committee will consider an issue that is directly relevant to the sponsor. We will explain the meeting’s focus to the sponsor and also may advise the sponsor about the information it may wish to include in its briefing materials. To facilitate the review and eventual posting of sponsor-prepared briefing materials, we strongly recommend that sponsors submit both paper and electronic versions of their materials. Sponsors should consult the appropriate FDA component about compatible electronic formats and consult the Designated Federal Official6 for a given meeting to determine the appropriate number of paper copies.7
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