But the FDA had no idea how to set up protocols and needed SI and Teva to help. Which they did. And the FDA then went on to ignore their OWN expert advisory committee which recommended APPROVAL for treatment of children who have aGVHD.
So you can pretend that the FDA is all knowing about this revolutionary step of stem cell and related technology, but it was and is an entirely new proposition for them and they've been in turns, ignorant and bloodyminded about it.
You're just giving me a slap down and hoping that those reading will think you sound like you're the greater authority. You are not.
The FDA has been brought kicking and screaming into this new era and it's not the first time they've been found wanting.
In fact the reputation of the FDA is at stake here.
The FDA has written papers about how it has to reform. So far it's not looking good and they are closing to have litigation.
So be it. I'm not for turning. And I sleep at night really well knowing I have a clear conscience.
CEO Itescu needs to go, page-279
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