Good point, The only reason I know that a SPA was not officially pursued in the phase III trial is because the regulations weren't foresighted enough to allow for a spa when the transition occurs. However, on the other hand, at the time the transition occurred, the FDA was supporting the concept of phase III accelerated approval utilizing the early interims for AA pursuit, and the latter interims for confirmation.
In the case of Direct and any latter L trials, the regulators will likely lay it all out in a spa, because the timeline and regulations allow for it.
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