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Re: Chuckles759 post# 84888

Tuesday, 06/16/2020 4:38:21 PM

Tuesday, June 16, 2020 4:38:21 PM

Post# of 233483
Chuckles - The "74 day letter" (due from the FDA July 10th - 74 days post BLA filing) is what we care about. Day 60? Only impact is that any refuse-to-file designation (won't happen) is due by then.

https://www.nuventra.com/resources/blog/submitting-your-fda-marketing-application/#:~:text=Refuse%20to%20file%20designations%20are,as%20the%2074%2DDay%20Letter.&text=Following%20review%20planning%2C%20FDA%20will,any%20major%20review%20milestone%20timelines.
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