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Re: loanranger post# 232607

Friday, 06/29/2018 7:28:21 AM

Friday, June 29, 2018 7:28:21 AM

Post# of 403025
Please note the guidelines say (if you are copying and pasting)

“Timelines for FDA response:
Within 60 calendar
days of receipt of the
request ”

It’s a response and not approval or disapproval. A response can range requests for more data and answer questions, to suggestions for what the FDA’s BTD might entail, to approval or disapproval. So, a BTD approval can take far longer than 60 days including any back and forth, request and response.

* Never borrow to invest.

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