ADRIAN:
No need to fear total rejection, Dean said we can keep on submitting forever...
The Money TV spot las t week @ 19:33 Dean stated:
"What I try to tell people is they will never totally deny us, if they don't like our package now, we can refile again, and that's the whole point of the 501(k) process is to find something you can compare the device to..."
No ytotal rejection, if the FDA doesn't like it, tweak something and resubmit..