PAR 0.00% 25.5¢ paradigm biopharmaceuticals limited..

Where we at?, page-556

  1. 4,252 Posts.
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    Babbanap,

    The TGA as part of their fifth criteria (see below) need PAR to have a clinical trial in the designated area to be completed within 6 years. Of course we could also arrange this independently with another jurisdiction thats recognised like the EMA. At the end of the day we really do want to pursue the FDA - USA.

    If we get a NO from TGA it isn't the end of the world...it would be sad...but its not the end for us.

    In my mind it if its a YES that's great and it might be earlier revenue...depends on our data and when the P3 starts etc.


    TGA Criteria:

    https://hotcopper.com.au/data/attachments/6259/6259388-2b29a4a426d31ac0632688c28a122e8a.jpg



    Ref: https://www.tga.gov.au/resources/resource/guidance/provisional-determination-eligibility-criteria


 
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