If they had done a proper randomised controlled trial in the...

If they had done a proper randomised controlled trial in the first place it would be meaningful. But since they didn't, it seems to be another belated attempt to rescue a trial which has foundered on inadequate methodology.

The Osiris phase 2 trial looked promising. But two properly conducted phase 3 trials failed to show efficacy for the same product. That's not too unusual. The MSB aGVHD trial isn't of any better standard than a phase 2 trial.

It's a long long way short of proof of efficacy. The best thing to do is a proper randomised controlled clinical trial. They've had time to do it, but SI has resisted because he's afraid it would fail. Instead he would prefer to clutch at the straws of the only clinical trial that he can try to assert was "successful" despite the limitations. The FDA shouldn't allow themselves to be cajoled into accepting less than the normal standard of proof. Every other company would have taken the recommendation to go and do a proper study. But not MSB.