It’s a feather in VRUS’ cap that the FDA is allowing one arm of the ELECTRON trial to test PSI-7977 monotherapy for as long as 12 weeks. Normally, the FDA limits monotherapy testing in HCV patients to very short periods (typically 3-5 days) to reduce the risk that patients will develop resistant mutations.
The fact that the patients in question have the comparably more treatable genotype-2/3 rather than genotype-1 surely played a role in the FDA’s willingness to allow 12 weeks of PSI-7977 monotherapy but, even so, the trial expansion announced today is a very impressive development, IMO.
“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”