All relevant facts, the FDA do have the final say, but items...

All relevant facts, the FDA do have the final say, but items such as Japan introducing new laws to FastTrack regenerative medicine in 2016 (not hyperhidrosis medicines), and the fact that the FDA did want an adult study conducted but MSB chose to not go that route, played big into the final result. Yes, MSB's drug was fast-tracked, but that means nothing if the data isn't up to convincing the FDA. And whilst a submission itself is accepted as 'complete', the fast tracking here meant MSB didn't get a mid-cycle review (as their review process only took 6 months). BOT on the other hand had a mid-cycle review where no issues were flagged. Yes the FDA said all good about MSB's manufacturing, but that doesn't seem to be the clincher here in rejecting the drug for the lack of data's sake. But anyway, again, the FDA always hold the final say. I do hope this is one of the main reasons we still haven't gone for a larger run - parties concerned that FDA approval may not occur. Hopefully we can expect to see even greater SP increases after FDA approval next month.