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Replies to post #208740 on Biotech Values

Replies to #208740 on Biotech Values
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DewDiligence

02/04/17 3:29 PM

#208744 RE: willyw #208740

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.