Culture War Roundup for the Week of November 30, 2020

Yes but 45% of total costs are capitalized time costs which themselves are 50% waiting for regulatory approval and 50% conducting the copious amounts of redundant studies. It's not 2-3 billion on R&D. It takes the FDA 10-12 years to approve a drug.

Those contract sequencing labs can't broadly exist unless they are also a clinical lab operating in a gray area on an LDT exception (which the FDA announced in 2016 it wanted to punish people for doing, scaring most of the investment away) or doing a very narrow sequencing application that the FDA has already approved. Even if those labs existed, in practice the hospital's administration in IT and legal is going to push so strongly against sending patient genetic samples out to a contract sequencing lab. Carrying that data back and forth is such a huge HIPAA liability. For those labs to exist they would need to get FDA approval for their entire workflow for each medical application of each sequencer they wanted to use(reagents, sequencer, analysis tools, medical application). It's an impossibly high standard and incredibly expensive.

/r/TheMotte Thread Parent