CEO Itescu needs to go, page-227

The gold standard is prospective, controlled, randomized and blinded.

Ah yes, telling us how to suck eggs.

The problem is that stem cells are different see? Let me count the ways...or maybe you need to go back to the drawing board and get a sense of perspective.

And that the FDA sees fit to allow continued emergency use for children, knows the Japanese have approved, refused the advice of their own expert panel 9-1 recommending approval and STILL won't allow MSB to go to market.

These are not practical nor ethical considerations are they?

The FDA is splitting hairs and require yet more demonstrations yet more proof, because the risk of allowing MSB to go to market is??

Start thinking like that, in terms of risk analysis and you will get somewhere. Otherwise you're just blinding with science and fudging the serious issues, like the FDA's inconsistencies and what looks like incompetence or something worse. It's almost like they've got into your brain.