My guess is that I3 get FDA approval either the first week of Aug. or the 2nd. The PPS will probably spike up to $3....something..$5 is being over optimistic but who knows it might...more is better than less.
Right - and most of it was to speed the review process through the extraneous questions asked by the previous review team and the answers Dean had to provide them - distractions to the actual review by this review team but they still had/have to go through them.
Technically a new submission but nothing really new in the application, additional notes and references to clarify what was asked for by the old team and answered previously and put into context.