In all seriousness, The Big Pharms (like other big Companies), hire firms that specialize in Lobbying. Their job? to fast track submissions ensuring that they don't get snarled in government red tape and I'm sure they also lobby to slow down reviews/approvals on Applications from others. While most were inquiring on when was their submission, I was inquiring on who was doing their lobbying? From my inquiring, NO one is. If INNV had hired a firm with the correct contacts, this would have been approved back in 2015. Bottom line? this submission is stuck in someone's "In Box" in DC and it won't be getting approved until this fall, when the three years are up.
Despite the above, this is a great company to have in your portfolio for a long term stock. I'm holding on to this for the next 2-3 years.