Ann: MSB Reports Q3 Financial Results and Operational Highlights, page-263

It could happen that way. The Canadian regulator granted conditional approval ten years ago on condition of another trial, but it never got done as far as I can see. The FDA might well be aware of that, along with the opposition by the company and the chief investigator to doing another trial. I mean, if the company was happy to do so, why waste the past two years arguing against it? But if the FDA now have "more teeth" to enforce progress on the obligation to do a further trial perhaps they will view the application with more benevolence. Remember the phase 2 trial by Osiris showed promise that wasn't confirmed by two phase 3 trials.