RE: I think today qdefinitely qualifies as 'early autumn'27 Sep 2021 22:20
I agree that clinical significance means nothing without statistical significance, I'm well aware that you can’t have the former without the latter. I also agree that that when considering this study’s primary endpoint which involved both bowel habit and abdominal pain, only the combined group was statistically significant.
I didn’t play liberal with my use of terms though. If I’m guilty of anything it’s that I didn’t specify that I was specifically referring to the additional analyses that they released earlier this year in May where they looked at bowel habits and abdominal pain independently. Blautix resulted in a statistically significant improvement in bowel habits, both for each group individually and combined. Furthermore, it had a positive effect on abdominal pain for both groups individually.
As noted in the same presentation…
FDA, Irritable Bowel Syndrome - Clinical Evaluation of Products for Treatment (2012). “A drug can be specifically developed to treat only one of the major signs or symptoms of IBS [abdominal pain or bowel habit], which should be identified as the primary endpoint in the clinical trial. The other key efficacy endpoints should be assessed in the clinical trial as secondary endpoints. Demonstration of significant and clinically meaningful changes in the targeted single endpoint could serve as a basis for approval, as long as the other important symptoms or signs have not worsened on treatment.”
In other words, for the phase 3 study they can target bowel habit only as the primary end point and if they see the same results as the additional phase 2 analyses for bowel habits and abdominal pain individually showed, that will meet the criteria.