In what way does the Montana law make snake oil salesmanship hard? Why can't a bad actor just repeatedly file INDs, go through Phase 1 (soon will be close to trivial given AI-enabled drug discovery/design), then sell to unsuspecting consumers as a panacea, then rinse and repeat?
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.
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Excellent example of precisely my point.