<sarcasm>these are just more governanace, or maybe governement issues. LOL What more do you need to know? Aren't you satisfied with the cartoon telling you how provenge works?
You could be right, but the non-disclosure of an event as consequential as a Form-483 report is not going to simply be forgotten
I submit that you haven't worked with the govt enough. How do you know that there aren't a lot of 483's that are never reported because they aren't material. Of course it would be hard for either of us to prove our side - the only way to know would be to have someone with background inside biotech (e.g. redplate).