iconoclast - "First, I am assuming that the FDA has indicated that they would give RVX Breakthrough Therapy in some indication.  Otherwise, RVX can be rightly accused of misleading guidance." 

I don't see where you get this from. Regarding Breakthrough Therapy status filings, DM said, "we believe we have what it takes to get that done in the next 90 to 120 days."  This is not a misleading statement and has no indication from the FDA. RVX just plans to apply for this because they think they have enough data.The FDA has not given them any direction yet. The FDA might tell them to get lost.

iconoclast - "The FDA...which was briefed on each and every data we could muster...must have decided that we are indeed fit for human patients...based on something that jumped out at them." 

Again, the FDA has not sent their letter to RVX yet. We do not have any clue what the FDA thinks. They might not like what they see at all. I doubt that but have no clue whether it is remotely close to issuing Breakthrough Therapy status or not.