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Re: sts66 post# 172392

Tuesday, 01/15/2019 12:52:35 PM

Tuesday, January 15, 2019 12:52:35 PM

Post# of 429019
I don’t see why a priority review would interfere with organizing an AC. See page 16. Even if we have an AC we should get it reviewed within 6 months.

https://www.fda.gov/downloads/aboutfda/centersoffices/cder/manualofpoliciesprocedures/ucm218757.pdf
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