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Member
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Join Date: Feb 2014
Posts: 365
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Member
Join Date: Feb 2014
Posts: 365
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Quote:
Originally Posted by Blackfeather
Assuming the trials for nilotinib go well and in a timely fashion, how long would it take to bring this drug to market. Are we looking at maybe 3 years or more like 5? How many more trials are necessary?
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Quote:
Phase II Clinical Trial: Assuming preliminary data from #1 is positive for application in humans, the second step would be a Phase II, double blind, multi-site clinical trial. In this study, half of the participants would receive the therapeutic and half the placebo. The patient population will be larger and the course of treatment would last 12 months. Study design and criteria for patient recruitment will be informed and refined by study #1. As a multi-site study it will be available to patients across the country at selected institutions. Timing for this study is still fluid and will depend both on data from study #1 and on funding. Ideally, we hope to have sufficient data to submit a request to the National Institutes of Health by mid-2014 to underwrite the study.
At present we are hoping to launch study #1 in early to mid 2014 with study #2 to follow late next year or early 2015.
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Last edited by Chemar; 05-13-2015 at 11:37 AM.
Reason: adding quote tags for the section copy/pasted from facebook
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