The delay with the trial may be down to the fact it's going to be multi-center. It's a big complication in terms of organisation. Once the centres have been chosen, for each one there will probably need to be a PI, approval of the protocol by an insitutional review board, standardisation of measurements, a local budget, etc, on top of which some arrangements may need to be centralised (eg, lab analyses so they're all comparable). It's a great pity it couldn't be a single center trial. 
But the silence from the company is inexcusable.