PAR 2.56% 20.0¢ paradigm biopharmaceuticals limited..

Ann: Global Market Research indicates price for Zilosu, page-54

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  1. 3,018 Posts.
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    It’s not that the TGA are not passing it’s just that they need something special to justify earlier “provisional” approval and without a Phase 3. They will happily pass later on like FDA and EMA if there was no DMOAD post a successful phase 3 pass.

    I still think the TGA should not need DMOAD given the special access history and results and safety data to date. But I suppose the TGA is just like the FDA and they require stringent data before approving anything in such a big indication effecting so many.
 
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