There perhaps a real measure of truth to what you say...I'm a...

There perhaps a real measure of truth to what you say...I'm a little surprised at the time-frame in this particular case for expected formal approval. Given it's a life and death thing involving kids. But two points.

1) We [MSB] are in the hands of the USFDA - we HAVE to deliver what has been agreed with them.
2) I have to believe, way smarter people than me [that's pretty much everyone on planet Earth] have designed and agreed the structure of the trial and this is important information for them.

Bonus point

3) We have come a long way, so we can enjoy the real achievement of the past few days and look to the future with great promise - kids, who NEED this stuff, can still apply for compassionate access [more WILL certainly start doing that] and before too long, it will be widely available in the USA and throughout much of the rest of developed world and in time, further afield.