PAR 2.27% 22.5¢ paradigm biopharmaceuticals limited..

I think we need to know if the FDA are going to stampour drug as...

  1. 300 Posts.
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    I think we need to know if the FDA are going to stamp
    our drug as DMOAD. This is the key item we need addressed
    before a value can be assigned to the asset. It appears this has been pushed back to Q1 2024.

    Further, MPS 1 asset has answered one of the unknowns, we are safe and effective for BOTH nezyme replacement therapy and bone marrow transplant therapy subjects.

    Also our MPS 6 asset (as Mozz points out) may obtain a commercial licence on the back of its study that is about to finalise in Brazil. The orphan indication, with potential fast track to market designation in Brazil, gives the company a price point for Zilosul, which we can point to in the various regulatory and commercial discussions that are upcoming.



 
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