Ann: Positive clinical trial results for Pericoach, page-13

I had to read it four times, here are my thoughts and what it all means.

They had 47 participants out of 90 who finished the enrolment process and completed the full trial. This must have been enough for them to be able to do a statistical analysis on the results. To me it appeared the trial was taking a longer time frame than anticipated, so they have done what they can with the results they have. There was no point continuing on with the trial on V2, if they have the results they need and they have moved on to V3 anyway. It would have just been a waste of resources and cash.

I also noticed they put the Quality of Life and Sexual Function improvements ahead of the UI improvements. They used words like "superior" and "significant improvement" because they were reporting to shareholders not scientists. They've provided the p-value (which shows whether the difference in the results from the control group vs the PeriCoach group is statistically significant - which they are for Sexual function and QOL). For the UI, the results were not statistically significantly different over the full length of the trial. But what they are saying is that BOTH groups are getting Clinician guided pelvic floor rehabilitation so both groups are expected to improve. What the result have shown, is that in the first four weeks, the PeriCoach group showed double the improvement than the Control group, but then it levelled out because the improvement scale is not linear and once a certain degree of improvement is made, it must get harder to then make further improvements which is why the control group "caught up". Again, both groups were getting supervised pelvic floor rehab, so if you think about the common woman who has UI and wants to do something about it herself, then this trial has shown that the PeriCoach will show improvement in UI.

The second last paragraph of the announcement is also very interesting.... the last sentence suggesting that they won't have to do a clinical trial on V3 because they can collect all the data remotely using every day users.

This is my interpretation only. Peasant, perhaps you should ring them, I know it has settled your questions and eased your nerves in the past.