FYI, below link to FDA website for info/definition of orphan designation:
https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products#:~:text=The%20FDA%20has%20authority%20to,Exemption%20from%20user%20fees
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Ann: Imugene Receives Orphan Drug Designation for VAXINIA, page-7
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