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Re: Chess Master post# 2492

Thursday, 09/29/2016 8:02:35 PM

Thursday, September 29, 2016 8:02:35 PM

Post# of 3839
I agree. I wonder how difficult/expensive it would be to reopen the Phase 1 and do a Cohort 4 at 12 mg/kg and then a Cohort 5 at 16 mg/kg.

Or perhaps it would be cheaper and quicker to mobilize Dr. Harrison. He might even be able to enroll some of the patients who just completed the NASH-FX trial. It would also be nice to set up this new Phase 1 trial with two parts per Cohort. The first part is the same protocol as the previous Phase 1. When this 1st part is completed for the 12 mg dose, then he could proceed immediately with the start of the 16 mg dose. For the second part of each Cohort, he would use the same dose but increase (double?) the frequency of the dosing. To be clear, I envision that the 2nd part for the 12 mg dose could/should proceed while the 1st part of the 16 mg Cohort is on-going.

It would be very poor planning on managements part if we were to get to December of 2017 and not have the basic information that would be provided by such a trial.

Clear to you me and the rest of the investing public that the dosage is the issue but obviously no clear to the "professionals" putting the trial together. They are totally shooting at the hip right now and honestly don't know what the correct dosing should be. I think they just used 8mg/kg because that is as far as their study went. This is just crazy to spend this sort of money on a trial with no dose escalation built in and I don't remember if they did any PK analysis to see how long this stays in the system. - Chess Master


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