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Ann: Phase 2 Synovial Fluid Biomarker Study Update, page-22

  1. 18 Posts.
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    I don't think they had much of a choice but to amend the 008 study as it was twice weekly. I get the impression FDA wants phase 3 to be once weekly dosing regime like it is in pets. No point doing a study and getting to the end and it proves DMOAD but in a dosing regime different to the planned phase 3? I don't see anything negative about the announcement, just an alteration. And I think we will get good news soon about trials starting in Europe and Australia. It is likely that PAR has now finalised the phase 3 drug protocol after accepting the FDA amendments, so they should have already got the go ahead despite us still waiting for the 30 day FDA turn around
 
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