Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

"Priority REVIEW can still be granted"

FWIW one source says:
"Priority Review: applications for drugs that treat a serious condition and, if approved, would provide a significant improvement in safety or effectiveness will receive this designation. FDA says the safety and efficacy determination is made on a case-by-case basis at the time of New Drug Application ("NDA")"

"A priority review designation means FDA intends to take action on the marketing application within six months of receipt (40 percent faster than the standard review)."
https://www.jonesday.com/FDA-Finalizes-Guidance-Document-on-Expedited-Programs-for-Serious-Conditions-06-27-2014/

Maybe you know:
I THINK an NDA is down the road apiece. Normally a meeting to discuss the submission of an NDA submission occurs AFTER a Phase 3 trial is conducted, isn't it?

This sentence appears in between the two quoted above:
"Notably, priority review designation does not require clinical trial evidence of these significant improvements, rather "other scientifically valid information" will do."

It seems inconsistent. If "safety and efficacy determination is made on a case-by-case basis at the time of New Drug Application" how can it "not require clinical trial evidence of these significant improvements"?