Ann: Medibio AGM Presentation, page-29

Speaking of "either a 3rd or 4th FDA submission" I have become a bit confused. Has the FDA submission for the device gone out considerably? In an April 2016 presentation, the FDA submission was projected to occur in Q4 2016. In the most recent presentation (Nov 2016) the FDA submission is projected to occur in H2 2017. Perhaps I am confused because there's more than one FDA submissions in the pipeline or perhaps I have otherwise misunderstood. If so, my apologies in advance. But has the most important FDA submission slipped significantly?