So ODAC (comprised of world-leading experts in the field) votes overwhelmingly in favor that it works, and FDA knocks it back on manufacturing concerns. Manufacturing inspection is conducted and checks out okay - with "no concerns"
On that basis - FDA requests another trial to see if it works.
Am I the only one here that feels like someone is jerking our chain?
Forget the trial, put that money into paying off US Senators (aka lobbying)...you'll never win working against the system.
Ann: Update on BLA for Graft Versus Host Disease, page-87
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