"How do you arrive at 6 Months for FDA?"
Date application/submission received: 27 April 2018
Approval Decision: 25 October 2018.
As you say, FDA approvals were managed by the CZM regulatory team. Presumably they know how to do the process expeditiously which is why it took the minimum time. I have heard the FDA doesn't look on simultaneous applications for regulatory approval favourably... maybe that had something to do with it. However the CZM application has succeeded, and that is what matters.
"How do you arrive at 6 Months for FDA?" Date...
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