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Re: piggerpig post# 184500

Tuesday, 12/09/2014 12:43:46 PM

Tuesday, December 09, 2014 12:43:46 PM

Post# of 252279
Yes, but you would hope the rate would decelerate rather than accelerate after significant dose reduction. At 30-month, CP-CML ATE SAE rate was 9.2 per 100 patient exposure years, at 38-month it is 10.4 per 100 patient exposure years - this is the metric the company liked to use.

In addition, you can look at phase 1 data with 48-month follow-up today, ATE SAE rate for CP-CML is 30%, ATE AE rate is 40% - can't compare to FDA number because FDA used all patients while ARIA presented only CP-CML- remember more than 1/3 of CP-CML patients in this trial started Iclusig at 30mg or lower, and then dose reduction at some point as well. You can pretty much draw inference from lower starting doses. I essentially agree with Peter, Iclusig efficacy is there even with lower dose, but ATE SAE rate will not drop much if any over time.

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