Ann: Update on BLA for Graft Versus Host Disease, page-765

I agree with most posters here ... it is very hard to sugar-coat the decision handed down on Friday.

@DocMcstuffins was certainly correct, the FDA wanted a RCT, rightly or wrongly. Unfortunately the FDA is being
super cautious with Stem Cells (I'm being very kind here), or perhaps they are being something else. Time will tell.

After taking in the CC, I will actually consider BUYing more. Why?

Simply put ... we may well be looking at an easier and shorter trial ... and these patients may actually be fairly easy to enrol
because there is no other therapy available. Then, in theory, we will have both the kids and adults covered.

This whole trial may not run anywhere as long as people are currently suggesting ... even DocMc ... but we will see.

MSB may not be as 'dead in the water' as some are suggesting. So, I will hold and probable buy.

Good luck all