Ann: MSB Reports Q3 Financial Results and Operational Highlights, page-267

The trial is of a level of evidence that's similar to the Osiris phase 2 trial. Osiris knew that it wasn't sufficient for approval which is why they conducted the phase 3 trials. It appears that the chief investigator didn't want to accept the results and conclusions of those trials however. Which is why we've arrived here follow ing a rejection of the BLA. At some point the FDA is going to insist on better quality evidence. And the impression is that SI has sought to avoid doing a further trial because of the possibility of failure as with the Osiris trials. So he would far rather speculate on the possibility that the cells are "more potent" than the ones provided by Osiris. But it's impossible to prove that without a further trial to provide a clinical correlation