The indictment does say that executives from both companies repeatedly warned both Kazem and Nader that Nader's timelines couldn't be met. The crazy thing about this is that nobody thought the BLA could be finished within Nader's timeline yet no one was able to stop the submission.

The big unknown for me is the importance of the change from 350mg to 700mg in the arbitration. That seems like it should loom very large because the change added massively to the amount of work it would have taken to finalize the BLA and there may be the possibility that it made the BLA unfileable without a further trial or the FDA agreeing to a phase 4.