All that we know is that the FDA still want clarification from BMSN on the proposed trial. It's not a rejection just further explanation. Think of it as courting a girl. You can't get to first base if the girl hasn't agreed to go out with you yet. The FDA has yet to agree to "go out" with BMSN. The FDA has done a few coffee dates with BMSN to feel BMSN out but hasn't yet agreed to the dinner. Make sense?