It’s not possible given his experience that he’s naive about the FDA. His investors certainly are not.
Other big venture firms, including GV, a16z, Casdin Capital, Section 32, Nextech, and Arboretum Ventures, have also signed on.
I’ve met with Arboretum. They likely know most of the relevant folk at the FDA. I’d say the opposite is more likely. He might know the FDA very well.
This is likely a chemistry/ip/regulatory arbitrage play. You make a drug that is like another, show it is very much like the other to lower approval barriers, get it on the market at a cut rate, then undercut everyone.