Yes, that is exactly where the mid-Apr completion date for genotoxicity test to be completed came from. That was March for genotoxicity test and 6 weeks for analysis. I was considering 'complete' being everything done (versus lab test done). But I am tagging 2ish more weeks to that because things can drag.
I don't think BDD approval is going to change anything about the IDE submission. I seriously doubt the people involved in the BDD approval are the same as the people involved in the IDE submission. Just my perspective on how government agencies are organized. I could be wrong, but the BDD typically gets approved well before submission of IDE. We are doing it differently because we were initially denied the BDD.
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