Revising what I said about the Rolontis delay. Here's why. I previously said I couldn’t understand why they couldn’t submit the BLA around the beginning of 2018. However, re-going over the timelines I now believe they could have submitted it in the spring. That’s still about 6 months earlier than they say they will submit it (towards end of 2018); 6 months vs what I initially was thinking (12 months). Here’s my reasoning. The 405 pt US study finished dosing in beginning of September. The primary endpoint is Duration of severe neutropenia (DSN) in Cycle 1 which is up to 21 days. I was assuming they can unblind at this point which takes us to the beginning of October, and another month to write the bioanalytical sub-report including QC and QAing the data. That takes us to the beginning of November. This is compiled along with other sub-reports on patients and dosing, etc, etc which were probably ready to go into the main report while waiting for the DSN analysis and the BLA would be compiled with the other pre-clinical and clinical studies that were done (including PK). So that's where I get my end of year submission date. Where I'm going wrong is that the study may not be unblinded till all 4 cycles are done so you would add 3 months to the timelines I just provided. Indeed, that would take us to a February date for top-line data and ASCO abstract submission placeholder. Where I'm still having a problem is they basically should be able to submit the BLA around this time so why 6 months later. A PK study should be finished and not the limiting factor IMO. So I think it’s suspect #1.
