sentiment_stocks,
That is a good argument and well defended but I still have an alternate explanation that might fit. The around 300 enrolled comment to the point 331 were actually enrolled appears to reflect a period of time that there were more than 48 patients remaining to be enrolled. The 17 not enrolled in the final tally very easily could be the last SOC patients that could have been enrolled but were prevented from entering due to ethical concerns about using a known lesser treatment on SOC (Spring refresh data). With this scenario in play a more rapid drop off in eventing might be expected at some point if treatment effect is substantial as fewer SOC PFS and OS events would be taking place after about 6-13 months from late August 2015 (September,October and early November being the months that lower numbers of SOC might have been enrolled). Now if this was actually the case, would a special exemption be needed for data analysis being considered for approval due to not meeting full enrollment and if so what listed exemptions from guidance might apply to this situation? Best wishes.
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