Aurinia Pharmaceuticals Inc (AUPH)

[CoolG73]

The only risk remaining would be the safety ( since the efficacy was proven at P<0.001 which means there is 0.1% chance that the results were caused by CHANCE).
so safety remains as a risk, but this risk was substantially reduced, not only with the mitigation measures and the severe vetting that the company did for the selected sites, but also the quality of sites selected. in phase 2 we had 6 sites out of 86 (7%)related to the Indian Subcontinent (Bengladesh and Siri Lanka), and those sites were able to recruit a whopping 60 patients out of 265 (23%). this was ridiculous and opened the gate to many mistakes and patients death.
in phase 3 , those 2 countries were removed, we have 187 sites for 358 patients, less load for each site (lessons learned from phase 2) and sites were better selected. Actually my analysis show there is only 5 countries that COULD present a safety challenge and if patient randomization is better implemented this time (and it should) there are only 9 to 10 patients at risk. to prorate the same % of death that we had in phase 2 from the 6 sites in Asia ( which were 9 deaths over the 22 patients treated with low dose (41%)) and considering the same rate for remote sites ( even though a site being remote does not automatically mean it present a safety risk if patients selected are of a good quality) then we are talking less than 4 death here or around 2%. I take these results any day