Hacker News Reader

Comment by colingauvin | Hacker News Reader

INDs and phase 1s are expensive and not trivial in any sense.

They're absolutely trivial compared to Phases 2 and 3, and part of the cost/complexity of Phase 1 is self-incurred because it's to the company's advantage to detect problems as early as possible. Remove that incentive (because they don't plan to pursue Phase 2, 3, or clearance), and it becomes much cheaper and easier to run broken Phase 1s.

Are you sure about that? I've not run a phase-1 but I'm often told the CMC is the most gnarly and expensive part of it & its due to requirements, not sponsor choices.

If you don’t need to make a drug that actually works, you can choose to make drugs that are very easy to produce instead, therefore CMC becomes way way way simpler.

Excellent example of precisely my point.

The FDA does not let you put something in humans without a significant amount of data, full stop. And even for a small trial, the cost of the GLP tox and the GMP manufacturing is in the millions.

Of course it is nowhere near as complex as phase 2. But it is not remotely trivial.

No one is interested in your personal assessment of what’s trivial or not.

I’m saying that the millions of dollars in expenses are irrelevant if you can recoup those costs plus some profit by selling snake oil.

Your comment is just “millions of dollars is a lot of money!” I don’t care whether you think that’s a lot of money.

If you think that cost cannot be recouped by selling snake oil for some reason, then explain why.

Reply on news.ycombinator.com