What kind of biomarker is this and how exactly does it help the trial? I assume the endpoint remains liver fibrosis?
Pasha Gainz
Pasha Gainz22 hours ago
Important and underappreciated FDA development for $ALT and MASH broadly! The FDA has officially qualified AIM-NASH, an AI-based histologic tool, for use in MASH clinical trials. This standardizes MASH and fibrosis assessment, reduces biopsy noise, and improves signal detection. For pemvidutide, this directly strengthens confidence in the upcoming 48-week biopsy data and materially de-risks Phase 3 design and regulatory review. Cleaner data, lower placebo noise, higher PoS. This is exactly the direction FDA has been moving, and $ALT is perfectly positioned!
@rtheoryxyz sorry they're also doing this. not the same people tho. those will presumably lead to less biopsies
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