Monday, January 21, 2019 10:32:54 AM
We have no idea what impact the patient censoring has on the data analysis. All we know is that the % of censored patients should be much lower in the Zenith20 trial and that the ITT and evaluable patients should be higher.
The most I can hope to do is look at the raw data provided and do simple analysis in hopes of predicting approximate likely outcomes. For instance should the ORR, DOR, mPFS ect get better or worse in the Zenith20 trial.
We started this discussion trying to explain why the FDA rejected the BTD. Most of us don't fully accept the suggestion that it was because of ORR. I think that you and I agree that the N used for DoR was very small and that that may be a good reason for rejection.
It does not really matter, but I feel a bit better with that conclusion than the idea that it was ORR.
It is what it is.
Most important is that we both agree that the target readouts will be better in the Zenith20 cohorts.
Thanks for the thoughtful feedback.
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