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Re: oc631 post# 121247

Wednesday, 06/08/2011 12:23:12 PM

Wednesday, June 08, 2011 12:23:12 PM

Post# of 252484
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.

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