Is it more difficult or time consuming to do the
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Quote:
Is it more difficult or time consuming to do the statistical analysis for that arm than the open label trial?
One wouldn't think so, no ... ... ... but maybe statisticians are in short supply?
Another NASH company (MDGL) delayed their statistical analysis:
https://finance.yahoo.com/news/madrigal-provi...00860.html
MDGL is believed to be the leader in NASH. They are doing liver biopsies in one of their large phase III trials. That will be the next step for us after these seemingly promising results in Phase II for NASH with leronlimab at 350 mg, if/when we go to Phase III (with a partner?). For the Phase III MDGL trial in NAFLD (NASH precursor) that was announced with delayed topline results, they will not be doing liver biopsy, and will look at MRI-PDFF just like we are doing. It will be a good comparison when their numbers and our numbers come out.