CEO Itescu needs to go, page-633

Doctor: so we have some promising information on helping your dieing child from SR-GVHD.
Mother: what is it Doctor?
Doctor: well, there is a therapy that we know is saving peoples lives & has been shown to be efficacious. Saving up to 50% of people that would normally die. And it’s totally safe with no side effects.
Mother: Oh wonderful. When can we get it?
Doctor: Well…Ummm. It might be next year or two or longer…
Mother: Why?
Doctor: Well…. There’s a regulatory body that says even though the therapy works it is made up of mixed cells. They want to know if some of the cells don’t work & might confuse the invitro potency assay readings. They don’t want to give your child a dose of cells that, although would work, may not be representative of the test tube result.
Mother: is that because it would be even worse than what my child is going through now?
Doctor: ummm…. No. As I said, it’s completely safe & it has no side effects. The reason is, the FDA needs to know the mechanism of action & whether it is the same in all the cells or some.
Mother: so it doesn’t work?
Doctor: Oh yes it works. Saving lives. There are heaps of cells in the mix that work but the FDA needs to know the mechanism of action of all the cells & that the dose is correct.
Mother: So there is a mixture of cells that works but this body is holding it back because they want to know the mechanism of action of some of the cells? F….ckkkkk!!!