Informed and positive YMB post I agree with many
Post# of 148110
I agree with many on this board that today's PR appears to be in need of correction to clarify the primary and secondary endpoint results. The headline says both endpoints were hit, but body of letter says only primary endpoint was hit. I'm sure there will be a clarification or correction given by tomorrow AM.
Based on the news (assuming primary EP was indeed hit with p-value less than .05), it is truly significant. This trial used MRI-PDFF (magnetic resonance imaging proton density fat fraction) as the main diagnostic tool for classifying the hepatic steatosis grade in patients with non-alcoholic fatty liver disease (NAFLD). This morning's PR was just a quick readout to inform investors, with top line data and biomarkers changes to support the results' findings which will get peer reviewed and published in a medical journal. In case folks don't know, this is becoming the standard for diagnosing NAFLD disease. Doing a liver biopsy is only necessary as a last resort option for those with advanced disease progression and to confirm PDFF reports so doctors can better design a treatment strategy. Hitting the secondary endpoint (iron-corrected T1 mapping representative of liver inflammation and fibrosis) is also important, but for now, let's assume the worst case in that it didn't. There could be a difference in the way the two diagnostic tools determine disease grade, but on the whole, the fact that it almost hit the p-value is truly significant since both diagnostic tools moved the needle to show LL's efficacy - and this was with the 350mg/weekly dosing only to boot!!!! Be encouraged LLongers, the 700mg readout will be greatly anticipated to hit p-values for all endpoints..... Not selling, not giving in to bashers and shorts. Keep the faith, for we know what we're investing in.....
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Le-Ron-Li-Mab, and they have not.