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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.