That’s why the have all those special dispensations approvals. About 120 from my memory, to treat people including children who would die otherwise. Been going on for about 5 years now.
All started when one burns surgeon rang the FDA to get approval to save a young girls life one day. He had a couple of sample kits in his office. They said go ahead. He saved the girls life.
And FDA have regularly given out batches of theses approvals ever since.
Patent extension, page-10
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