Aurinia Pharmaceuticals Inc (AUPH)

[CoolG73]

Maciste,

he was talking about the difference between P2 and P3 in the inclusion criteria. in P2, a 6 month biopsy was required when in P3 they increased the interval to 24 months which allows the treatment of some patients that have a longer LN history (which is not good normally because those are normally non responsive to treatment, and I was a bit worried actually about this change between P2 and P3), but what Neil said is they did it to allow for a small number to participate in the study (around 10%) and it doesn't have an impact on the study results (since the 10% will be split between both arms and impacts both of them. This change got me concerned that the % would be much bigger than 10% but Neil's answer clarified things). I think this is a requirement of the FDA same as they needed to have a certain % of Class V in the trial.
Overall, I was extremely satisfied with the CC and Neil's answers, it cleared a lot of my concerns regarding some of the points that were kept a bit foggy.