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Biotech / Medical : Madrigal Pharmaceuticals
MDGL 418.90-2.0%Oct 31 9:30 AM EST
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To: tuck who wrote (113)7/20/2019 1:51:00 AM
From: Miljenko Zuanic   of 138
 
<5.Biopsy-proven NASH (Baseline liver biopsy) based on a liver biopsy obtained within 24 weeks before anticipated date of randomization (if the biopsy is deemed acceptable for interpretation by the central reader) with fibrosis stage 1A, 1B, 2, or 3 on liver biopsy and NAS of = 4 with a score of at least 1 in each of the following NAS components: >

Stage 1A/B was already part of the enrolment criteria. First 900 will have 450 of the F3, so I am not much concerned with power (80 and 100 mg seems almost as one)...but enrolment center(s) is something that I do not understand well. Central CRO, that control all centers?

Further, as mentioned early, exclusion of the T2D on GLP-1 is much more disappointment than anything else.
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