> VRTX – so there will be safety data on WAY more than 1000 patients.<
OK—I’ll give you 2,000 or even 2,500. But I’m still not sure I agree that a safety problem in a combo trial in the treatment-refractory setting would not taint the safety database in the treatment-naïve setting.
If the FDA saw a serious—perhaps life-threatening—problem in a combination trial, they could place a clinical hold on all VX-950 development until they sorted it out. Is this a risk VRTX will be willing to take?
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