Quote:
Originally Posted by lady_express_44
It's not "drug", so does it even need FDA approval to be marketed?
So, it just fades away as an option?
Cherie
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Yes it does require FDA approval. It's a vaccine, a blood product, and thus FDA approval is required. Clinical trials are required. They have applied for a patent and who knows, if they get more funding, they could reapply and get approval to continue the Phase III open label trial.