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Re: bradfor123 post# 819

Friday, 04/04/2014 12:09:42 PM

Friday, April 04, 2014 12:09:42 PM

Post# of 3833
bradfor123: Thank you. I posted part of an article that was published on the web and posted it. I didn't change any of the facts that the author wrote. It stated 1 year. It is not my information. I really don't have an answer other than it is likely that it took longer than 1 year so I agree with you.

If you read the animal studies for GR-MD-02 and then compare phase 1 cohort results, you will see that they directly correlate. That was the biggest unknown as to whether the drug would respond in humans as well as it did in rats. Cohort 1 was only at a dose 40% of the top dose given to the rats. As the dose in rats increased, the results in the rats improved. I would expect the phase 1, cohort 3 patients to be almost if not completely cured. For that matter, I believe that even the first cohort (just completed) had years added to their lives. You have to ask yourself how long will the FDA want patients to receive placebo for a deadly disease with people dying if there is a cure? These are people and there is no treatment for late stage liver fibrosis or cirrhosis. I don't know but I highly suspect there is a reason why Galectin has included measuring efficacy biomarkers in a phase one study. If the study reaches safety endpoints and proves curative efficacy by the end of the phase 1, then I think that phase 2 could be very short because the endpoint could possibly be met very quickly. Once you reach statistically significant efficacy (meaning the remainder of the untreated results can be thrown out) and you still have efficacy factoring in no results for those patients then phase 2 will likely end. Remember that phase 2 will be at doses with proven efficacy from phase 1. All IMO.
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