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TankTheFrank

12/18/23 7:03 AM

#41188 RE: cowtown jay #41186

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.