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Re: Kilroy101 post# 215709

Monday, 09/23/2019 12:54:29 PM

Monday, September 23, 2019 12:54:29 PM

Post# of 426505
The briefing docs will be released to the public at least two full business days prior to the Adcom meeting and from memory I seem to recall that the docs are released to the sponsor and the panelists 14 to 21 days prior to the Adcom meeting. I have the FDA Adcom guidelines saved on a PC and if I get a chance I’ll look for it and reply to this post if necessary. Edit: I just read through the guidelines on my phone and the 14 to 21 days I posted is correct, along with of course the 2 full business days for public release on the FDA website.

https://www.fda.gov/media/75436/download
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