We've been through this before. Never let FDA policies get in the way of your agenda hey?
https://www.fda.gov/industry/developing-products-rare-diseases-conditions/designating-orphan-product-drugs-and-biological-products
"The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and effectiveness of a drug must be established through adequate and well-controlled studies."
Ann: Positive Final Results in Stroke Study CUV801, page-32
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