This is the fifth offical strategy for Race so we need a commercialisation strategy to run its course. Whilst I accept the pivots to date runs on the board are needed (i.e. DACS needs to eventuate to something).
What keeps me up at night is the VO2 peak endpoint. If not accepted by FDA, industry or Pharma where does that leave us? If it’s truly gold standard why was it only picked up after input from a shareholder, and, LVEF is the go to measurement?
I can see it used as an endpoint in some clinical trials, but all approvals for cardio protection are based on LVEF, must be a reason for this.
Also I don’t fully understand what the approval indication would be for in P2? Is it only breast cancer, all-comers indications, or simply cardioprotection?
Is FTO irrelevant as a biomarker for commercialisation until CDx is developed and validated in a clinical trial for RC220 and any new molecule?
Just my train of thought of where I see the next hurdles.
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