I don't believe it's possible to tackle the gatekeeper or incumbents and win. You have to bypass them altogether before revisiting them. You have to, in Bill Gu

I don't believe it's possible to tackle the gatekeeper or incumbents and win. You have to bypass them altogether before revisiting them. You have to, in Bill Gurley's words, have an orthogonal solution to the problem. My words, you have to be 100% disruptive. Or, you seek fast-track, accelerated approval, breakthrough therapy, and/or priority review, but then you will likely come across and have to compete against the incumbents, who've by the way woken-up on the orphan disease problem too. Truth is, we have bigger problems than orphan diseases in the world. Biotech startups should be tackling major diseases and focusing on transformative innovation, by questions the fundamentals.