It's obvious that most people are confused about what type of...

It's obvious that most people are confused about what type of company they've invested in. Biomarkers are not important as a standalone. The FDA or TGA will not approve or reject iPPS on the basis of biomarkers. These biomarkers alone also will not be accepted as a surrogate endpoint for OA. They are simply being measured to gather more information about how iPPS works and the data will be used when applying for registration. It would be nice to be able to tie these results to all other endpoints, but it's not essential.

The most important part of this study is whether the primary endpoint is met. Why? Because if the primary is met then all of the secondaries come into play. Just by taking a quick look at the primary endpoint will show you that it's going to be really difficult to fail.

Primary outcome [1] To evaluate the effect of PPS on synovial fluid biomarkers associated with inflammation in participants with knee osteoarthritis (OA) pain. (Method of assessment is via synovial fluid biopsy).

Timepoint [1] Change from Baseline at Day 56 in one or more synovial fluid biomarkers, including but not limited to cartilage oligomeric matrix protein (COMP), C terminal telopeptide (CTX) -II, NGF, interleukin (IL) -1ß, TNFa, IL-6, a disintegrin and metalloproteinase with thrombospondin motif 5 (ADAMTS-5), ARGS (aggrecan cleavage fragments, tissue inhibitor matrix metalloproteinase 1 (TIMP-1), CTX-I, and type II collagen (C2C). Synovial fluid biomarker samples will be taken at Baseline and Day 56.

Primary outcome [2] To evaluate the effect of PPS on synovial fluid biomarkers associated with Osteoarthritis (OA) disease progression in participants with knee OA pain. . (Method of assessment is via synovial fluid biopsy).

Timepoint [2] Change from Baseline at Day 56 in one or more synovial fluid biomarkers, including but not limited to cartilage oligomeric matrix protein (COMP), C terminal telopeptide (CTX) -II, NGF, interleukin (IL) -1ß, TNFa, IL-6, a disintegrin and metalloproteinase with thrombospondin motif 5 (ADAMTS-5), ARGS (aggrecan cleavage fragments, tissue inhibitor matrix metalloproteinase 1 (TIMP-1), CTX-I, and type II collagen (C2C). Synovial fluid biomarker samples will be taken at Baseline and Day 56 Method of assessment is testing for biomarkers is by synovial fluid biopsy.