For 1st line, I'd think it would need to conduct randomized trial vs Gleevec. The outcome is anything but certain.
They are planning that trial already - it is planned to start next year. In terms of efficacy I have little doubts about the outcome - note both Sprycel and Tasigna fairly easily beat Gleevec in terms of efficacy, and pona is likely superior to them both (although that would be virtually impossible to prove in 1st line patients).