Find me a drug for a non-fatal disease that was submitted with two trials - one with p<0.01 and one with p between 0.05 and 0.10 - that was rejected in the last 3 years. Then I'll admit you might have a strong case.
the fda will not approve a drug that has met its primary endpoint in only one phase 3 trial for the indication of Fibromyalgia. end of story.
forest always does things the cheap way and this is another example. I believe what they want to do is have the drug rejected and when cypress gets clobbered they will buy it at a discount.
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