When you engage someone as an expert "in the field'...IF he comes across a wrinkle in the landscape..HE/SHE should pick up a phone and get the expert in that field..,.After all, you are getting $10 Million a year to remedy the situation...Total Nonsense that it should take 3 years to submit it properly with continued instructions from the big, bad FDA. They are painting the picture for you...you are blind...and should say so...or you are willfully sabotaging the effort.