4 ms·
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 GM
by colingauvin 8d ago
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.
- estearum 8d agoNo 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.
- deleted 8d ago[deleted]