1, Yes they do need a phase 3 but it is easier to recruit for diagnostic trials as there is less risk so a phase 3 trial would be completed quicker
2. I would essentially hold off on any theranostic programs getting approved before 2027-2028. Diagnostic agents can be approved by 2025.
- They might have enough cash by 2025 if they sell their Priority Review Vouchers (they're valued at 100-120million each). That might keep them afloat if they don't want to do a capital raise. Although any good release of data between now till they run out of cash will most likely be followed by a capital raise
- They may also get some revenue on their SARTATE Neuroblastoma program, but they at least need a Pivotal Phase 2/3 trial that'll take a while to recruit. FDA (from Y-Mabs approach) will reject any premature submission of data.
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