RE: Sat 04 May 202413 May 2024 17:55
Bothwell, this certainly has the hallmarks of classic Gibson waffle, simply re-hashing past half-truths, and with lines lifted verbatim from past releases. Or has someone been helping you play with ChatGPT?
As for the PRO results "speaking for themselves", the published data screams "no significant difference in post-treatment IELT between treatment and placebo", a 50% placebo response versus 70% treatment response for subjective endpoints, and probably most damning of all with respect to PRO validation, no difference in global impression of change between treatment and placebo groups at end of treatment. True, the difference between means for Item 3 did reach significance (P = 0.0031), but impossible to interpret this in the absence of clear-cut objective and subjective treatment effects.
So, do you have the guts to look at the data (simple comparison of means is all that's needed), or too frightened to test faith with fact? Or why not cut through the waffle and ask outright "has the FDA accepted that the Phase II study data validates bother as an acceptable co-primary endpoint, and that the PEBEQ is now validated as an appropriate instrument"?