Hi RL,
Thank you, I understand how you have come to this conclusion now, and yes I had considered that only 20 patients on the trial could potentially show any legacy effect, being in the first treatment cohort.
What I don’t understand is if your conclusion is correct, why would the DSMB not stop the trial if 14/40 patients were actually showing a 25% increase in albuminuria on treatment, which is very significant & I believe would need to be reported in safety data also, that the drug was having the opposite effect in a significant number of patients? Plus Professor Packham answered No to the question raised about an increase in albuminuria.
I see how you have come to this conclusion though. Did you ask the company?
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