research reports and media, page-4276

Based on the data published by Paradigm from trials to date for OA on knees the process for Provisional Approval by the TGA IMO should be a pass through as it meets all of the criteria. There is no known better treatment for OA on the knees (unless someone does know a better one) and the alternative for people with severe OA is pain killers, which have known downsides.
If IPPS is safe after looking at data from trials to date and its also known safe long term usage for other illnesses then why bother with a double blind Phase 3 trial. There is enough published evidence of the progression of OA in the knees and a double blind trial cannot easily address and measure the impacts from lifestyles of the participants, which are a significant contributor to the OA progression and outcomes in individuals.
If I was to place myself in the seat of the TGA there may only be one key issue that may hold me back from Provisional Approval.
That is the actual data collected and tabled by Paradigm.
Where is the independent peer review that would give the TGA a high level of confidence in the data.

All I have seen to date is data published by Paradigm and anonymous statements by persons who may have trialed iPPS. For all I know those people may be members of the Nigerian Royal Family.