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Re: sts66 post# 29733

Tuesday, 06/24/2014 2:51:55 PM

Tuesday, June 24, 2014 2:51:55 PM

Post# of 427426
"The two week BD release rule" - such rule does not exist!

The rule: "21 through 14" - "Business Days Before Meeting" "We will send a copy of our briefing materials (or relevant portions thereof), as prepared for public release, to the sponsor to review"

Unless, you have access to AMRN internal system / information you could not know when and what was sent to / communicated with AMRN.

"No later than 2 full business days before the day on which the sponsor’s topic will be discussed" - "We will post on our Web site both the sponsor's and the agency’s publicly available briefing materials." - DONE

Read the Guidance: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125650.pdf

and EPADI CP did not challenge the BD release date ...

Maybe you are confused since - as I remember - FDA usually release the BD to the public 2 weeks ahead, but according to guidance it's required by 2 full business day.
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