I think the other possibility is that they gain some kind of...

I think the other possibility is that they gain some kind of conditional approval, along the lines of the Canadian regulator. But to do that I think the FDA have to overlook some of the problems with the original trial and then try to enforce the condition of a new trial within a definite time frame. Since SI has been touting a label extension to adults then maybe the FDA would want a RCT in adults within the next two years. No label extension without a successful adult trial and if adequate progress is not made then the conditional approval gets pulled. That would keep the company in business and provide an opportunity to come up with the goods, not that the FDA should necessarily be concerned with the viability of any company. They weren't concerned about OSIRIS (although they did make some kind of deal over the two remaining trial products).