The FDA is highly unlikely to ever approve a treatment when the trial stopped and restarted, has dragged on for 7 years and had its name changed from Phase 2 to Phase 3. Regardless of how promising the data may appear it's too sloppy IMO.
Why wouldn't the FDA approve a treatment? What matters is the data, not how they got there. And they've more or less stated (by approving the upgrade to a phase three trial) that the current form of the trial will provide the necessary data.