The FDA are taking a cautious approach, who would have thought? This is a treatment which is going to cost a couple of hundred thousand for each child treated, the FDA need to get it right. I find their decision not surprising. For those who are crying buying opportunity, buying opportunity; take a bex and a long lie down as the prospect is you will lose even more money. For those crying "but the kids, the kids", you should not be investing at all!
Ann: Update on BLA for Graft Versus Host Disease, page-212
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