"They will have to give their approval simply so they dont look like incompetents."
....like, what part of 'broader market approval' (EU and Russian) don't they understand?
My guess is, the 'perceived delay' may not really be a delay at all. Just that we have been overly optimistic in our timeframes for approval, overlooking the possible fact that LTC genset and tools could be the 'largest approval' that the FDA has been requested of, in quite sometime.