A key design feature of the trial is an interim analysis of efficacy. This analysis will take place 12 months after half of the patients in the trial have been randomized. The interim analysis will focus on the primary endpoint of the MMR rate at 12 months of treatment and, depending on the results, may allow ARIAD to file for regulatory approval of ponatinib in the newly diagnosed clinical setting approximately six months earlier than otherwise.
I wonder what the best case scenario might be. Front line approval in approximately 20 - 24 months?
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