Replies to post #167608 on Biotech Values

[DewDiligence]

The TURQUOISE-1 study is currently enrolling so you might want to add it to the cheat sheet.

Already done—see the updated and expanded Cheat Sheet in #msg-92025068 :- )

[DewDiligence]

There's no direct correlation between the TURQUOISE-1 and TURQUOISE-2 studies. Do you think TURQUOISE-1 was originally designed to stratify GT1A and GT1B cirrhotic patients?

I presume you’re asking if TURQUOISE-1 and TURQUOISE-2 were originally intended to be a matched set of trials for cirrhotic patients with GT1a and GT1b, respectively (or vice-versa). That’s possible, but it’s hard to reach such a conclusion merely from the naming of the various trials.

If the trial design were up to me, I would’ve had a phase-3 trial for cirrhotic patients that contained 4 arms in a 2x2 matrix for genotype (1a vs 1b) and duration of treatment (12w vs 24w); that would’ve accomplished the same thing as having two trials devoted to cirrhotic patients as you suggested.

[jq1234]

I think the correlation between TURQUOISE-1 and 2 is same study design, 12-wk arm vs 24-wk arm, one for cirrhosis patients, one for HIV co-infection, as they are now because all other registration trials exclude cirrhosis patients and HIV patients. It's natural to have one study for each of these excluded patients, cirrhosis and HIV. For whatever reason we don't know, TURQUOISE-1 started well after TURQUOISE-2.