In other words you are saying that if Omapro is approved in the t315i mutation that ARIA will be given the opportunity to run a placebo controlled trial
Would it be ethical for the FDA to allow ARIA to put people on a placebo when Chemgenex has proven that their drug works and has been approved. It would be unethical to run a placebo controlled trial. If Omapro isn't approved then you would be right.
The fda is probably curious to find out if Omapro in addition to a tki would result in cures and a pivotal trial would be a good way for them to find out.
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