On this:
Based on this data Paradigm intends to proceed with a Provisional Approval application to the TGA.
i feel vindicated for pushing it to the Board for many moons.
The main reason is that it leads to early revenue and authentication in the marketplace and provides the FDA 'cover' if they need it for a fastpath, and DMOAD labeling.
IMO.DYOR.
Ann: iPPS SIGNIFICANT OA PAIN REDUCTION AT 12 MONTHS, page-47
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