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Re: KMBJN post# 322677

Wednesday, 09/09/2020 6:43:29 AM

Wednesday, September 09, 2020 6:43:29 AM

Post# of 403018
Is a pre ind required? I will look for the fda link later that talks about being able to go straight to the ind so long as you can submit a complete package and being able to get a quicker response then 30 days. Its the page that refers to briefing packages and the fda only providing wro as responses vs in person meetings or teleconferences.

the above is all IMHO (consider this my safe harbor statement)

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