Rumble said in the new May 2012 submission cc that there was strong reason in Dec 2011 to believe that would be the last submission. The FDA has forced 3 or 4 different submissions if you count the upcoming one, since that date so I don't think they are too concerned about TOS.

FDA reminds me of inspector Columbo who keeps coming up with comments like, "There is just one thing that puzzles me now." Rumble said in this cc that there is no way to project the timeline when FDA approval will be given.