Comment by ethbr1
1 day ago
The difference is that phased safety/efficacy trial costs are sunk.
If it fails, you've produced near $0 value, aside from some more information (maybe) about how something doesn't work. Because those costs are strictly for the execution of the trial, not for the development work before/during/after it.
That's in contrast to your hardware prototyping example, where a failed prototype still usually represents >$0 development value.
The appropriate analogy would be if every time a hardware prototype failed testing, it was required by regulation to scrap it, go back to the design stage, and restart from there.
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