To: Lynn who wrote (3 ) 10/20/2018 12:37:18 AM From: tuck 1 RecommendationRecommended By DewDiligence_on_SI
Respond to of 138 Re use of MRI-PDFF Association Between Magnetic Resonance Imaging–Proton Density Fat Fraction and Liver Histology Features in Patients With Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis An excerpt from the full text version says: "“PDFF does not appear to be a strong predictor of advanced liver fibrosis or NASH for an individual patient, but may be more useful for risk stratification,” the researchers wrote. “Our data suggest that at the time of diagnosis, a patient with high liver fat content may or may not have NASH. These results suggest that for optimal patient management, techniques other than (or combined with) MRI-PDFF such as ultrasound- or MRI-based elastography or liver biopsy remain necessary for assessing hepatic parenchymal changes other than steatosis.”A company called Endra Life Sciences is trying to develop an ultrasound method that will do this. It won't be in time to help MDGL in its P3, but might be worth keeping an eye on. The ability to handle the screening more effectively in terms of both volume and cost could really help the NASH market. Endra Life Sciences Presentation I've only just come across this company & technique, so I don't have anything insightful to add to what I've pasted at this time. But as someone with a position in MDGL, I am curious. They are about to commence a trial, and I gather it can be done in a matter of weeks, not months or years. I suppose if the trial reads out well, NASH treatment companies in clinical development could talk to the FDA about adding cohorts with it. But the trial is only in Canada, as far as I currently know, so it might be a while before it can be used here, even if successful. Cheers, Tuck