Replies to post #168328 on Biotech Values

[DewDiligence]

ABBV/ENTA—HIV co-infection part is recommended, while cirrhosis is strongly suggested, see the wording difference there, thus ABBV/ENTA to include cirrhosis in original NDA, but not HIV co-infection.

The staging of TURQUOISE-1 and TURQUOISE-2 was more of a business decision than a regulatory decision, IMO.

It’s very important for ABBV/ENTA to have GT1 cirrhotic patients on-label from the get-go, while promoting the GT1 regimen for HCV/HIV co-infected patients can wait. The initial label will not explicitly exclude HIV patients, but rather will say that the drug cocktail has not (yet) been tested in HIV patients.

[dewophile]

Thanks for posting the draft guidance

Has GILD guided on their planned submission in gen-1 yet? I ask because clinicaltrials.gov still has their cirrhotic study listed as enrolling. It also has a 24 week arm. so, it does appear to be behind their non-cirrhotic study even though both are estimated to be completed more or less the same time (latter part of 2014)