Re:Silicon Valley’s Ultimate Exit (2013)
by avn2109 on Thursday January 19, 2017 @11:44PM
(#13441774)
>> "...people in the drug discovery business do not see the FDA as an obstacle to doing business."
Let me play devil's advocate here and suggest that entrenched market participants love high-barrier-to-entry regulatory regimes. The FDA is "people in the drug discovery business'" moat.
Re:Silicon Valley’s Ultimate Exit (2013)
by HarryHirsch on Friday January 20, 2017 @08:23AM
(#13443589)
When you do drug discovery and development safety and efficacy is your concern. Your aims and the FDA's coincide. It's Pharma-Bro Shkreli who uses the FDA as a moat, but I think the general public sees him as an aberration and pharma wishes he would just go away because he draws the wrong kind of attention.
Re:Silicon Valley’s Ultimate Exit (2013)
by yummyfajitas on Thursday January 19, 2017 @11:46PM
(#13441786)
When cost comes down, financing becomes simpler, right?
Re:Silicon Valley’s Ultimate Exit (2013)
by HarryHirsch on Friday January 20, 2017 @08:19AM
(#13443562)
It's the risk that kills it. If your compound fails at late Stage 2 or early Stage 3 you just did 7 years for nothing. Also: the penguin effect. A first-in-class compound requires target validation, which adds another few years plus you can't patent that effort, and then the stuff arrives at market and physicians don't know why they should prescribe it. Just compare profit from the first statin to current 5th-generation profits from that same class. Silicon Valley is so much more predictable and offers returns in a shorter timeframe.
For genuine public health emergencies (anyone remember AIDS?) there's fast-track approval, the first antiretrovirals were at market remarkably quickly.