It’s not possible given his experience that he’s naive about the FDA. His investors certainly are not. 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.Other big venture firms, including GV, a16z, Casdin Capital, Section 32, Nextech, and Arboretum Ventures, have also signed on.
. . . That's why we're having tons of problems with failing medical devices like bad artificial hips and meshes and such. It's a total mess and has caused so many people undue stress, pain, and medical complications. I can only imagine that a similar approach to medicine would have similar results. Here's a scary yet entertaining twenty minutes.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.
There is no regulatory arbitrage. You make a drug that is like another, show it is very much like the other and you still get to go through the full approval process. I have a friend whose very-much-like-the-other cancer treatment drug failed efficacy. Burned ten years of her life. Let's say you've got a honey at the FDA. Let's say that you've fellated all the right people and things are going to sail through. You think Merck isn't going to injunctify your ass until the end of time to keep you from undercutting them? This is an Uber play whereby the argument is that regulations will allow them to skate until the laws catch up... but since it's the FDA, the laws are already there. Not buyin' a word of this.