@whytee
By the way, with a near 85% morality rate with aGVHD patients, a double blind study is unnecessary. I have to spell it out for you because each time I state this you don't get it, so I'm trying another way:
The reason for double blind and placebo is you must identify that the treatment works, with no possibility of intervention or bias.
Here for untreated aGVHD patients receiving the placebo there is close to an 85% chance of dying.
Get it?
So that makes doing a trial with a placebo unethical but especially for kiddies.
You do like to see your kiddies splashing about in the pool, so how would you like to put one of them sick with aGVHD in a clinical trial with those odds?
When the efficacy of remestemcell-L has been proven to close to invert the death rate, it's about 70% survival.
THIS is why the FDA allows emergency use for aGVHD paediatric patients.
BECAUSE THERE IS NO OTHER OPTION!
All other options have been exhausted.
Get it? They're facing death rate untreated that are that high.
Unethical isn't it? But you keep screaming for it like a robot.
Think about it, as a mother. At some point you're going to get this.
I'm really getting fed up with your persistence because you just refuse, refuse to learn let alone accumulate knowledge or absorb the longer detailed posts from researchers, let alone respond to them. Instead we get your short sledges and they rain down every day on repeat.
This is the problem with downrampers they repeat things they don't understand, and try to slant the story and trigger selling.
The fact is that the FDA is fiddling to get the maximum certainty about batches they also delayed approval with not approving the trial format.
BUT even with all this obfuscation they still allow emergency use BECAUSE IT WORKS!
I hope there is a God because if so, all of you including FDA officials will need to line up at some point and explain yourselves.
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