Jsut curious that might be our only hiccup..any advice or did they already do a crl??
There won't be one! If there is, 1 Qtr max. Approval in 3rd Qtr. I see no major issues here.
the fda gives crl= complete reponse letter, in this which they will give the company what they need to get a certain drug approved. more trials can cripple a company