no way go to jail go directly to jail do not pass go do not collect $200 i believe the co is only required to announce approval or abandonment of the application as an end result of failure to receive approval most cos choose to report a crl in that event at the least here is relevant info on fdas side of things https://www.fda.gov/downloads/AboutFDA/Transparency/PublicDisclosure/GlossaryofAcronymsandAbbreviations/UCM211747.pdf remember every time the fda returns the application and the co has to resubmit it starts a new 6 month cycle i think innv has been through 3 or 4 of these and most recently enough to decide to make this dead mans deal with ww