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Re: AVII77 post# 2098

Tuesday, 03/20/2018 4:48:36 PM

Tuesday, March 20, 2018 4:48:36 PM

Post# of 3283
Nothing to be sorry about. I respect your expertise regarding this stuff and thanks for providing it. So for the P2 data, they evaluated the data and provided p values for both non-inferiority and superiority as one test and, like the P3, I did not see it as a secondary endpoint in CT web. Since its one test, can superiority be mentioned on the label anywhere? I don't think so but I'm still thinking that they can market it that way. TEVA seemed to have done that w their Neulasta biosim in the EU (http://www.pharmatimes.com/news/teva_gets_eu_nod_for_neulasta_biobetter_1005530), marketing it as a biobetter. Just looking to see if Rolontis can be differentiated using the data generated.