Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

"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."
(Is there a way to do that other than case-by-case"?)

As logical as that sounds it still seems inconsistent with a few other FDA statements/documents:

"When to submit request
With original BLA, NDA, or efficacy supplement"


"Priority review can be for all reviews including those between trials. It’s not just for a NDA or end-of-phase 3 review."
"Features
Shorter clock for review of marketing application (6 months compared with the 10-month standard review)"


https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf p.8
That's my source. I'd be happy to read yours.