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This doesn't work, if you need expose patients to a novel drug to gather data.



The era of medicine where we administer a 100 mg pill of a small molecule to 3000 patients, calculate a P value and release it for sale is dead. There's a huge industry, so it's not aware of its death yet, but the research world has moved on. I think the paradigm will be based around deep understanding of the genomics, proteomics, histology, spatial distribution of the problem in the body, and licensing for sale platforms that produce custom proteins, T cells, small molecules, <intervention of choice>, designed on the fly. It's 30 years out, but if you're betting the bank on a small molecule in a phase 3 trial, that model is only going to hold up for so long.




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