Tuesday, May 08, 2018 2:02:48 PM
Piggy back as you put it isn't probably possible in the FDA's procedures.
A fresh 501K is or a PMA. how they represent the existing clearance and the new data which they submitted earlier is what they will discuss. They have the Real World Data study as well which is now admissible and wasn't last year.
At the end of the meeting I hope we hear who was in attendance from FDA (Positions at least) and the next actions and anticipated timescale as discussed.
They can move fast if it is presented correctly.
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