Your post requires more in-depth elaboration in regard to the reference to "other scientifically valid information" will do." Please provide three examples of what might qualify as meeting this rather nebulous standard, along with authoritative sources to support your examples. If it takes you the rest of the day, please know that we all are very much appreciative of your efforts. Have a nice day.
A priority review can be granted at any time, including prior to Phase 1. That’s why the FDA states clinical evidence is not necessary, and it’s case by case. Priority review can be for all reviews including those between trials. It’s not just for a NDA or end-of-phase 3 review.
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