I should also point out that:
- FDA has approved seamless transition from Phase 1 to Phase 2 subject to efficacy signals without stopping the trial between phases
- Car T registrations have historically been allowed after Phase 2 (not Phase 3), which reduces the cost and timelines but tens of millions and many years
- FDA fast track designation is a given if there are efficacy signals
- First patient dosing is imminent ie any day now
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