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Re: willyw post# 208740

Saturday, 02/04/2017 3:29:30 PM

Saturday, February 04, 2017 3:29:30 PM

Post# of 257295
For original NDAs and BLAs (as opposed to sNDAs and sBLAs), the 6-month or 10-month review clock starts when the application is accepted by the FDA for filing—not when the application was submitted.

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