Replies to post #118594 on Biotech Values

[iwfal]

GILD Trials out of sequence -

In other GILD news, an all-oral phase-2 trial testing GS5885 + GS9451+ GS9190 + ribavirin is planned to begin as soon as the FDA clears the protocol.

GS5885 is an NS5A inhibitor, GS9190 is a non-nuke, and GS9451 is a PI that’s the successor to GS9256 (which is evidently defunct).

This plus your "quiz" about GILD filing a combo NDA prior to one of the two drugs having its individual NDA are both about GILD trying to move things out of sequence. It will be interesting to see if they succeed.

As for the drug combo you listed above it would appear that both GS5885 and GS9451 have been through only cursory ph i's (both show 1 3 day trial - which showed good efficacy, but without much time to know side effects). In contrast the drugs being used in BMY's trial of multiple permutations/combinations of 2DAAs, rib and ifn-L all had long ph i's plus even a 2DAA drug interaction trial. I'd bet the FDA requires some lead in trials (or the trial gets split into part a, part b ...) - especially if they are trying to run a trial in treatment naives.