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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This trial, conceptually, is somewhat similar to the Isradipine Steady-PD trial. In that study the FDA required a 1 year phase 2 (which was successfully completed). The phase 3 commenced the end of 2014/ beginning of 2015 and is designed as a 3 year trial. If the FDA required a similar timeline, and taking into account time for patient recruitment, data analysis, NDA submittal and FDA review, you would have a minimum of 6 years. Of course, there is interim monitoring and if the results warranted it, the trial could be stopped earlier.