RE:Reddit Post Question A few points to make. The follow on monitoring months are standard and the drug has a 10 year record of safety and they are not changing the dosage. Their last drug approval on Trogarzo, the FDA cut short their follow on safety monitoring. So they have a solid reputation with FDA which may or may not come ein to play. But the additional safety protocol is a GOOD issue to face.
ART therapy in HIV has been shown to cause a very poor liver environment characterized as a more rapid buildup of fat and fibrosis progression for HIV patients. Fibrosis progresses at roughly twice the rate versus non HIV. So it is a tougher liver to bring back to health.
Ed Nash had the same criticism on whether GH would stimulate a non HIV liver the same way and someone here answered that eloquently before as did Marsolais and Grinspoon. There is the study that correlates overall severe obesity (which coincides often with NASH) to a severe lack of GH secretion. It's in all the latest THTX presentations. So there is a direct MOA to rectify one of the major causes of liver fat accumulation. The Loomba meta study showed that consistently in all the scientific journals investigating NASH that a 30% or greater reduction in liver fat content was the tipping point for the liver to heal and lower steotosis, inflammation and ballooning. Few have achieved that level but THTX did in an even more stubborn fatty liver buttressed by ART drugs aiding the fat accumulation.