RE:RE:RE:RE:RE:RE:RE:RE:FDA accepted Intercept’s NDA for NASH!
palinc2000 wrote: IF and its a big IF THTX is in the process of negotiating a deal in Nash we can assume that it will be very complex ......because Tesamorelin is already in the market for the treatment of Lipo....unless THTX retains all rights on Tesamorelin for PLWH(lipo and Nash)
https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/hep.31177
https://pubmed.ncbi.nlm.nih.gov/36642292/
Speaking about PLWH and suffering from NAFLD/NASH the prevalence of this group of people is much higher than NASH in general population and many NASH trials have excluded HIV patients due to drug drug interactions among others. About 1.2 M people in the US have HIV based on this recent report (biopsy confirmed prevalence)for PLWH NASH was over 48 percent, point is this is a sizeable number of cases so if THTX keep the rights for that segment during that potential partnership.
“A total of 43 studies, reporting data for 8230 patients met our eligibility criteria and were included in the meta-analysis. Based on imaging studies the overall pooled prevalence of NAFLD and moderate liver fibrosis (METAVIR ≥ F2) among PLWH monoinfection was 33.9% (95% CI: 29.67%-38.39%), and 12.00% (95% CI: 10.02%-14.12%), respectively. Based on biopsy studies, prevalence of NASH and significant liver fibrosis (stage ≥ F2 on histology), was 48.77% (95% CI: 34.30-63.34%) and 23.34% (95% CI: 14.98-32.75%), respectively.”