GREY:ATBPF - Post by User
Comment by
RjM2018on Apr 23, 2021 8:11pm
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Post# 33060313
RE:A couple of "stupid" questions
RE:A couple of "stupid" questionsP3 further reduces risk. Although we showed statistically signifcant effiacy and safety with 250mg & 200mg doses, the 150mg dose wasn't powered for statistical significance. There was a very clear signal that the 150mg dose could be stat. sig. efficacious. Phase 3 trial is an adaptive design, in that they will study lower doses (like, 200mg, 150mg, 125/100mg) to find the lowest effective dose for go-to-market over 6 weeks vs 2 weeks for phase 2b.
Risks is that because the duration of treatment is 3x longer, AEs could arise...