It seems to be that the strategy has also levelled up!
Level 1 - PARTNERING OPPORTUNITY
AML we went from two costly trials focusing on R/R AML in which one would only likely result in a licensing deal. To one trial with a close alliance and now include cardio protect POC. AML 2-In-1 trial.
Level 2 - VALUE IMPROVEMENT + COST REDUCTION
The original plan was mBC for POC of cardio protect in limited patient population. We now have broad spectrum cancers + cardio protect + FTO POC. This takes addressable market from mBC to all cancers + all anthracycline treatments for those cancer. This is Triangle report best case + global use. 3-in-1 approach
Level 3 - FASTER APPROVAL PATHWAY
Fast track / Breakthrough and Priority review voucher, speeding up pathway to approval rather than end-to-end trials. Also, chance that cardiac and FTO data can be used for conditional approval for CDx?
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