Again, these are pre-submission discussions. FDA only makes suggestions for the IDE application. They don't formally request anything. Now obviously, if one doesn't comply with a suggestion, the odds of approval drop accordingly. So one could argue it's a distinction without a difference. Hence why MK's resistance and foot dragging was nuts. Time is $.
Also it's been clear from updates the "new" reviewers were at first meeting. So it's a mystery what was meant by new, new from when? My guess is new from the failed BDD application. Apparently MK is clueless that he burn a bridge with the lead reviewer in that case.