No Ohm , one don’t need to submit , and submit ,
Post# of 157598
They have meetings with FDA where they presenting their arguments , and protocol is negotiated .
Make a great points , put all in a written form , and if you do have a good arguments let’s see if they refuse on the paper .
I will like to see written now that our company asked FDA and they wrote NO .
This is not confidential , let’s see it ..

