This work is immensely important as in terms of number of lives...

This work is immensely important as in terms of number of lives with the potential to be positively impacted quickly it’s the indication with the shortest potential timeframe for large scale adoption in the clinic.

The planned Phase 2b Proof of Concept trial ( probably no more than 50 patients ) will ideally lead to a large scale (100s of patients) global multicentre Phase 2 trial with FDA Breakthrough Therapy designation.

I think a large Phase 2 trial with some sites in US would be minimum needed for an FDA Accelerated Approval ( however by the time such a trial commences RACE could potentially be in the hands of a big pharma ).

It would be wonderful if a Big Pharma could roll out cardioprotection at scale by 2026 timeframe.

I’m pondering if the dosage via central line (as used for AML) and a suitable US registration-directed trial leads to potentially more rapid approval (for AML) then a sufficiently sized Phase 2B for Breast Cancer may be enough to encourage oncologists to use Zantrene off-label for Breast Cancer.