Low-volume Copaxone should not require any “heavy lifting” to get FDA approval—all it needs are some legitimate clinical trials to show safety and efficacy. That Teva did not conduct such trials suggests to me that the low-volume Copaxone program was never a serious attempt to develop a commercial product, but rather was a sham intended to circumvent the question that Teva has no answer for: How does Teva meet its very aggressive sales and EPS guidance for the next five years if Copaxone goes generic?
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