4 ms·

Here's a fun data point: people in the drug discovery business do not see the FDA as an obstacle to doing business. It's the financing model that's commonly see

Here's a fun data point: people in the drug discovery business do not see the FDA as an obstacle to doing business. It's the financing model that's commonly seen as troublesome, with the low-hanging fruit gone coming distant second. For genuine public health emergencies (anyone remember AIDS?) there's fast-track approval, the first antiretrovirals were at market remarkably quickly.

avn2109 10y ago
>> "...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.
- HarryHirsch 10y ago
  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.
yummyfajitas 10y ago
When cost comes down, financing becomes simpler, right?
- HarryHirsch 10y ago
  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.