I tend to agree generally.
So they have treated half already - probably 15 twice daily and 15 placebo.
Lost a few months re-configuring the trial and now the second half will be 5 twice weekly, 5 placebo and 20 once weekly.
They seem to have pretty clear data from the first half at twice weekly to have the luxury to use the second half to expand the data collected. Note this deliberate comment in relation to the first half... All subjects have completed the treatment course and reached day 56, the primary endpoint for the study.
They have the primary results from this cohort already and are telling us that!
Extension of final timepoint from 6 months to 12 months is only a positive thing (more data for free), and the reasons are spelt out pretty clearly. Primary endpoint readout is still 8 weeks. Yes the whole program has slipped almost 6 months (now 3Q22 for primary readout) and I'll give them a black mark for taking so long with this update and for not explaining why a 6 month slip when the program has been paused for 3 months. But it seems to me that the data must be looking good so far. So good they are happy to halve the dose?
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- Ann: Phase 2 Synovial Fluid Biomarker Study Update
Ann: Phase 2 Synovial Fluid Biomarker Study Update, page-36
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