I’m not sure but if I were to speculate I would say the FDA is the one deciding this overall. I feel like management is in the dark here and is putting their trust in the FDAs direction. I’m giving the FDA the benefit here.

I think this is why NP isn’t always accurate on his information because he makes it sound like he doesn’t have it all. I am Kinda surprised and at the same time I’m wondering if the FDA has way more control over all of this or just maybe management is using their best judgment to let the FDA help get them across the line.