GREY:ATBPF - Post by User
Comment by
Thejew on Jun 02, 2020 10:00am
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Post# 31100923
RE:RE:Phase 2b Review - Medical Only
RE:RE:Phase 2b Review - Medical OnlyFrom IR:
To your question about WOMAC scores … in this trial, we used a WOMAC multi-part 500-point scale rather than a 20-point, simpler scale (the FDA prefers a 500 point scale for larger trials such as this one) … these WOMAC numbers are extremely hard to interpret if you’re not a stats or pain expert… as noted above, it’s all about the statistical significance (p-values). The p-values are the key result and the central numerical facts in discussions with commercial partners and regulators, and they demonstrate strong efficacy, comparable to efficacy shown by other NSAIDs at the 4-6 week mark, which tends to be the point where max efficacy is reached with NSAIDs (note that our data is at the 14-day mark). These results are similar to and consistent with the earlier (albeit much smaller) Phase 2A trial. To your question regarding follow up, the statisticians at Veristat are in the process of summarizing the WOMAC data that underlies the p-values we reported, and we expect to provide a summary of that data on our website later this month – we will alert you when it’s available.