I think the market put a negative on this ANN mainly due to the...

I think the market put a negative on this ANN mainly due to the below paragraph:




DMOAD is an extra bonus, while pain and function is the key for Paradigm. Although we know the study is not powered to demostrate significance, I think the market still wanted to see it is statistically significant change (p<0.05) at Day168 in WOMAC scores. However the study showed function and overall in WOMAC at day168 is not statistically significant, and there is no data for pain at day168. I guess the market did not deem it as a good sign.

But I need to point it out here is the primary endpoint for our main 002 trial is pain at Day 56 (which we've already seen a very good pain and function data in PARA_OA 008 day 56), and there are 3 key secondary endpoints: function at day 56, pain at day 84, function at day 84. My understanding is : as long as we meet the primary endpoint (pain at day56) and key secondary endpoints (function at day56 , pain&function at day84), the drug is safe and have no serious AEs, it is highly likely we will get FDA approved. So it is fantastic if we have statistically significant improve at day 168, however it won't change the fundamental if p>0.05 at day168. Please correct me here if I'm wrong.



I think the market is also confusing about the dose selection, as from the study it showed twice weekly dose is better for WOMAC, while once weekly is better for DMOAD. Previously the market deemed twice weekly will be the selection, now the market is unsure what would be happened. If once weekly being selected, would this affect WOMAC score? Or if twice weekly being selected, how's DMOAD going? Market doesn't like the uncertainty.



https://clinicaltrials.gov/ct2/show/NCT04809376?term=pentosan&cntry=AU&draw=2&rank=2