BOT 1.33% 37.0¢ botanix pharmaceuticals ltd

Ann: FDA Qualified Infectious Disease Product Status for BTX 1801, page-16

  1. 204 Posts.
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    This is fantastic. Particularly enthralled to read this:

    "The major incentive afforded to a product with QIDP status is an additional 5 years of regulatory
    exclusivity, on top of the standard regulatory exclusivity that comes with FDA approval of a New Drug
    Application (NDA). This incentive could potentially enhance the value of a successful product as it
    provides an extra 5 years of protection, during which period, generics cannot enter the market."

 
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