I thought the (nearly 12?) months it tookto get the IND approval for our 80,000 page Phase 3 trial design submission meant we were already clear... hence the massive spend already incurred to implement what was approved?
Or is the FDA approval that this thread is referring to just a confirmation we can go with the 2x2 regimen?
I thought the (nearly 12?) months it tookto get the IND approval...
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