OUR CEO has spoken......so has the FDA.
In particular, the FDA previously noted in their commentary to the Oncologic Drugs Advisory Committee (ODAC) concerns about the manufacturing process used to produce remestemcel-L, i.e. a reliance upon multiple donors and the impact this has upon product consistency, and also the nature of the clinical trials conducted in support of the BLA.
"In SI we trust"
FAIL.
The Science Will Do The Talking, page-84
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