>> Are they so confident of the dosing schedule that they don't need the PII data? <<
They will need some of the phase-2 data to design the phase-3 trials, but not all of it.
My feelings are not mixed at all; given the tremendous promise of this drug in this indication, I think it’s incumbent on management to expedite the clinical-development program to the maximum degree possible within the regulatory framework.
A Special Protocol Assessment, which will almost certainly be implemented for the phase-3 trials, will greatly reduce the risk of using a somewhat compressed timeline.
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