No need to use such a large font to get my attention :D VO2Peak...

No need to use such a large font to get my attention

VO2Peak is the FDA gold standard in cardiology. If we were developing bisantrene as a cardioprotective drug we would go to the FDA cardiac division and say we wanted to use VO2Peak and they would say excellent.

What was picked up by the shareholder was how much effect anthracyclines have on VO2Peak. This is something very new in oncology and not known by oncologists. You can detect the change in LVEF by other techniques like cardiac MRI or 3D echo, but the clinical significance of these changes is unknown - the great thing about VO2Peak is the changes are considered clinically significant even when small and the changes caused by anthracyclines are not small.

I would add that using VO2Peak as an endpoint in an oncology trial greatly increases the chances that we would get breakthrough designation and accelerated approval. Any FDA IND will have to be a cross-divisional application with involvement of both the oncology and cardiology divisions. This is exactly what real breakthrough drugs provide.