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Re: Cognition post# 249307

Tuesday, 11/20/2018 8:44:38 AM

Tuesday, November 20, 2018 8:44:38 AM

Post# of 403039
Take a look at question 21. Within 60 days.

https://www.fda.gov/regulatoryinformation/lawsenforcedbyfda/significantamendmentstothefdcact/fdasia/ucm341027.htm

“21) What are the timelines for FDA to respond to a breakthrough therapy designation request?
FDA will respond to breakthrough therapy designation requests within 60 days of receipt of the request.”

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