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Re: Chess Master post# 2496

Friday, 09/30/2016 5:12:05 PM

Friday, September 30, 2016 5:12:05 PM

Post# of 3834
Phase 1 certainly is about safety and that is my point. If we want to use a dose higher than 8mg, there has to be a safety trial showing that those higher doses are in fact safe. Right now they can't increase the dose in a Phase 2 trial beyond 8mg. They can increase the frequency, but not the size of the dose.

I think we need to try the 12mg and 16mg doses. Remember that the patients in the previous Phase 1 did have NASH, so using the "non-invasive" tests we could see signs of efficacy in a new Phase 1 using the higher doses. And don't forget about my proposal that the second part of the trial use increased frequency of dosing...

Let me say that Phase I is safety so we don't need to go there. It would go a long way if mgt came out with a new phase II trial that was structured properly with dose escalation. Remember this drug worked on psoriasis it just wasn't high enough. Also keep in mind there was little change from the first 13 weeks. Why? was it intervals between dosing or perhaps the dose itself. We don't know and that is the problem. They need to do dose escalation in preparation that their CX trial was poorly designed. - Chess Master


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