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sts66

02/19/18 4:09 PM

#122808 RE: Biobillionair #122800

Yes, gold standard for NASH is liver biopsy - one of the reasons it's difficult to run NASH drug trials, it's a highly invasive procedure - ultrasound can be used to diagnose NAFLD (how I learned I had it), but it's not accepted by FDA as valid proof for showing a NASH drug works. I think there may be some kind of PET-like scans that come close (MDGL P2 data did not rely on biopsies), but you need to get diagnostic scans or other types of tests FDA approved to be used for official disease confirmation by comparing them to current standard, meaning if that PET-like scan is promising, whomever owns the rights to it would have to run a trial to compare it to liver biopsies to prove it's just as good.