CUV 6.00% $14.58 clinuvel pharmaceuticals limited

We've been through this before. Never let FDA policies get in...

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    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."

 
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