Looks like the FDA needs a hand making a decision.
ODAC to the rescue. Now that would be a good nights entertainment.
All of the REACH trials 1 , 2 & 3 were complete rubbish and even then they only proved how dangerous the drug is. As for efficacy the way they were put together in a open label manner with inclusion exclusion criteria renders that data meaningless.
@stanjupiter may like to add a citizen partition for discussion .
Cell Therapy News/Articles, page-9527
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