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frrol

04/22/18 11:28 AM

#225583 RE: PlentyParanoid #225579

Yes, about the SD. Back to averages, the paper cited similar averages in other studies. We're at double the average time now with P, at approx 140 days. Sox posted that Otezla's (larger) Phase 2B took 4.5 months, or approx 145 days. I believe that's as good a benchmark as any.

It's reasonable to expect an announcement about P results "soon", given the above. I think management was optimistic on trial completion, which is not unusual, and understandable given the historical norms above. That it has taken this long though, there were likely data "issues" not anticipated, which could be as innocuous as questionnaire or CSR inconsistencies. There may have also been protocol violations, eg a few too many false positives on the HLA-B*5701 allele blood tests that need to be cleared up; you don't want P to be blamed for a bad reaction. We just don't know, and management is not saying because they may not know either.