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Posted On: 06/12/2022 3:53:27 PM
Post# of 148899
Re: chazzledazzle #124651
Quote:
22:44 Recknor: That's a huge decrease in patients. and this study that we did, did not look at biopsy, (that would be for the Phase 3 study), but we wanted something that would be quick, that we could get results back and look at through 350mg vs. 700mg, to see if we had a signal. And when you do biopsies, you are looking for about a 40ms drop change, with 80ms, you are going to get biopsy changes, changes that represent the decrease in that cT1. Actually, I think we are going to get an accentuation of the biopsy results in the phase 3. So 80ms is phenominal, the most impressive thing though is that this is in the severe, we are seeing this in severe patients where we didn't previously think you could get resolution of fibrosis.
It is very clear now why the results are so much stronger in the SEVERE, in the full blown NASH patients. NAS 6, 7 & 8. RESOLUTION OF FIBROSIS
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24:47 Nader: Yeah, and some people are saying in other NASH trials, they do a 1,000 patients, so we probably need a partnership, with 1000, 2000 or 10,000 patients, if you hit your primary & secondary endpoint, (which we did), that's a huge deal. We don't know what we have, cause we haven't unblinded it yet, but we are really waiting to see how that comes out.
Does Brendan Rey come to mind?
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