Point being, the FDA knows Leronlimab well at this stage. They know it’s safe and they’re familiar with its MOA. I assume NP shared some of the cancer data in conversations with FDA and they essentially said file the BTD in an unofficial “rolling submission” and send more data as it comes in.

I doubt NP woke up one day and thought “Hey, I know we only have preliminary data from a couple of patients but, what the hell, let’s go for it.”