They don't need FDA approval to start a registration trial.
No they don't but I'd think they would want it nonetheless. If they intend on only enrolling pts who have failed 2 tki's then the trial design is fairly straight-forward. However, if the intend on enrolling pts who specifically have the T315I mutation then I'd like to see them get some clarification in advance in order to avoid some of the issues that were raised during the omapro hearing.
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