Well, the case of Setipiprant is very interesting. It has 8 clinical trials completed, including a phase 3 and safety data with thousands of patients. Under the current FDA rules, they'd have to complete a phase 2 poc and a phase 3. However, there is a bill that just passed Congress that has almost universal support, called the "21st Century Cures Act." I'd say there is a 95% chance it gets signed into law. The plan has also always been to sign it into law before the year is out, because 2016 is an election year.
Under the new law, I strongly believe a drug like this will get consideration for it's vast safety data and the number of trials it has already completed. It may just have to show efficacy.
Under the new law, I strongly believe a drug like this will get consideration for it's vast safety data and the number of trials it has already completed. It may just have to show efficacy.
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