Real world approvals for drugs are accelerating through, even with all the steps. Think about it, Moderna went from zero, to approved vaccine in 10 months. While COVID vaccines were the exception, not the rule, there are ways to accelerate the process if there is will and $$$. In the last 20 years, the number of new drug approvals per year in the US has doubled, and the length of time to get approval has been cut in half.