Precisely, now why would MK want to rush what the guidance is. That would only increase chances of errors. Therefore some individuals on here that complain about timing and ineptness need to chill as MK is following the guidance and making sure all that is required is submitted with no ability to refute the results of an excellent product
By the time the submit the final IDE there won't much new in it. The containment topic has already been discussed at length and the report may only be a box-checking exercise at this time. We will know soon.
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