Most of these things die quietly or never get started so we never really see the true costs of what it takes to push the pharma world forward. It likely has a big effect on reinforcing existing monopolies as they are the only ones who can play that game (and pharma has been dominated by the same six companies since the 1800s). Usually R&D happens via a single trajectory which is either expensive internal labs at these companies or via anointed universities. There is very little variation on the source.
There's rarely an investment market between small scale seed stage and high growth phase. Which is where these bio R&D projects die.
Maybe there is an opportunity for a YC-style org to disrupt here. But I doubt it given the requirements to get to market.
It's the in vitro -> in vivo part that they're anxious about wasting money on, not the FDA process.
That's not necessarily a bad thing.
Maybe you can get approved in Australia or Sweden, but that will pay negligible sums compared to getting into the US market.
Well said -- the keyword is "sense" of security.