Aurinia Pharmaceuticals Inc (AUPH)

[CoolG73]

Jess, you can read this link, it can tell you all what you need to know on the details of P2.

https://www.researchgate.net/publication/328830731_A_randomized_controlled_double-blind_study_comparing_the_efficacy_and_safety_of_dose-ranging_voclosporin_with_placebo_in_achieving_remission_in_patients_with_active_lupus_nephritis

just to be clear, again, I am not saying that they will fail P3. if the delta of 10% as mentioned in the CC is enough to get a p<0.05 then it is still doable. All I was saying through my posts yesterday that I don't think they can beat P2 numbers , that is all. Few things to consider in this P3 that are different than P2:
1) the race mix is different, no Asian Indian and less White and increase in Hispanic and Black
2) more patients with a longer history of LN but management said it is less than 10% and won't impact the results
3) the change in race could impact the % of patients achieving a CR after 24 weeks. in P2, 100% remained in CR after 24 weeks but this can change now with a different pool of patients ( remember that AURION had 2 patients out of 7 relapse between 24 and 48 weeks , and they were Asian)

my final take on this is that P2 were the best results we could have. P3 will have lower % but I still believe strongly that it will be enough to give us a p<0.05, and this is all we need to get a potential approval from the FDA.
Also, we should never forget the safety issue. this is a wild card and there is no concrete de risk, even though I am more comfortable with the measures they took in this phase