But it is a low risk level device ? What data could possibly go...

But it is a low risk level device ? What data could possibly go wrong ?
They had their chance with MHRA post market and seemingly through lack of insight of some sort of supposed compliance by people running the trial in a specific group ( both arms presumably) and it became underpowered as 1 x 5 year group seems to have fallen off cliff and others were on the slope. I tried data and couldn't get a sensible result to reproduce their explanation without some silly assumptions and overloading the 35 -45 y age groups numbers and lack of response and data . hopefully just another poorly written report to shareholders with words used incorrectly or was it very well crafted?