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Re: cowtown jay post# 41186

Monday, 12/18/2023 7:03:57 AM

Monday, December 18, 2023 7:03:57 AM

Post# of 44348
We probably should have engaged with CBER early on to work with them prior to regulatory submission. From what I am reading they are hot and heavy on pre submission engagement with stakeholders.... they have rolled out a couple programs that look like it could have facilitated better results by keeping them In the know and engaged with our product.

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