RE:RE:RE:RE:RE:RE:RE:TWO STUDIES: GO !The FDA shold probably publish a new NASH testing guidance document. A lot of water has gone under the bridge since their first one and they should probably update it based on what they have learned since then.
qwerty22 wrote: My memory is that I've heard or read NASH company execs talk about the drug needing to beat placebo by 10%. So if 10% of patients resolve NASH in the placebo then the drug needs to get 20%. It seems like a low number but it fits with Intercept's data. They believed they had hit their target when the primary endpoint (fibrosis reduction) came in with 11.9% in placebo and 23.1% in the treatment arm. That then got parsed against the safety profile and got rejected by the FDA, that was when discussion turned to whether the FDA was moving the goalposts. So my guess is it's 10% difference to placebo assuming a benign safety profile, might be wrong.
palinc2000 wrote:
The primary endpoint used to seek accelerated approval will be the percentage of participants achieving NASH resolution and no worsening of fibrosis compared to placebo.
Question
Do they know the targeted % and if so why would they keep this secret? Competive or else?