The NASH CX study is blinded but the number of patients and power of the study is definitely open to analysis. On the recent call we learned that the FDA was one of the key drivers in GALT’s trial design that assumed a 25% dropout rate. This isn’t surprising given the recent reductions of recruitment in other trials where the need for a liver biopsy was having an effect on patient recruitment. This is probably why the FDA suggested a robust trial design to account for significant dropouts. Liver biopsies by themselves are delicate procedures that entail significant risks to patients. Anecdotally it’s not hard to draw the conclusion that the reason for such a disparity in the unusually low drop-out rate is due to the clinical activity of the drug. Traber reflected, that to date “a total of 10 dropouts out of 162, which is a 6% rate.” Keep in mind the trial was designed for 156 and in a way was oversubscribed. Having 152 patients left in the trial at this late stage is quite encouraging since if you assume the current dropout rate continues then only 5 more patients would be expected to drop out over remaining 5 months of the trial ending in August. The reason this point is important goes to the power of the study which should be approximately 95%. It is clear that any efficacy data out of this trial should be treated a pivotal.
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