Replies to post #156480 on Biotech Values

[DewDiligence]

I’m not as cynical as oc631, so I don’t think GILD is seeking to profit by treating many genotype-3 patients twice rather than once.

If extending Sofosbuvir + ribavirin from 12w to 16w does not make a significant improvement in the FUSION study, I think GILD will look to add a third drug—not necessarily GS-5885—for genotype-3.

[oc631]

Yes, but will the FDA approve it? [Sofosbuvir/Ribavirin]

GT3 patients will also have the option to be treated with Sofosbuvir/PegRiba until a more viable oral combination is developed.

[DewDiligence]

GILD—Yes, but will the FDA approve it?

My reply in #msg-84225008 didn’t give a yes or no answer because I don’t think GILD will include genotype-3 in the Sofusbuvir/ribavirin NDA submission if they can’t do better than the 56% SVR seen in FISSION. Rather, they will submit an NDA for genotypes-1 and -2 and deal with genotype-3 in a subsequent filing.