A serious question for the board...
Many here have claimed that, had our p2 trial (which was actually a p3 designed trial) not had issues/sabotage, we could have been approved by now.
Given that trial's data reconstitution and a (hopefully) positive showing in p3, with Bavi performance validating the p2 results, would the FDA not use a little common sense here and allow approval? Considering all data at once, we've essentially run two phase 3s, have excellent results in one,.....and may have great Bavi results in another with a freakish control arm as the only detractor.