Replies to post #126129 on Biotech Values

[oc631]

So, sounds like they think the nuke has issues combining with pegIFN. Is that your take?

That's what GILD would like investors to believe at this point.

How do they know the SAEs aren't attributable to the nuke alone or to their PI, either alone, or in combo with another agent?

They don't. I personally believe there's more to the story and the FDA is being accommodating by allowing them to continue oral development. The street won't be so kind come Monday IMO.

[DewDiligence]

GILD—So, they are dropping their nuke (GS 9190) from these trials, which also includes one of their PIs (GS 9451 or GS 9256), pegylated interferon, and ribavirin.

GS 9190 is a non-nuke.

[oc631]

Interesting. So, they are dropping [GS 9190] from these trials, which also includes one of their PIs (GS 9451 or GS 9256), pegylated interferon, and ribavirin.

The P.I.'s appear to be getting a clean bill because single SAE's were experienced in separate studies which is understandable in hindsight. If GS9190 is responsible for the SAE's (which I feel is more than likely) GILD may setback their protease inhibitor development program if SAE's reappear again in oral combo studies.