Replies to post #250861 on Innovation Pharmaceuticals Inc (IPIX)

[BooDog]

Just about going on a month with no news. Pressure is back building. Some keep on making stuff up as if it were fact. Agree we'll see something this week or next. And it very well could spark one heck of a rally.

Get the partnership and start realizing where the SP should be!!

$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"?

[To infinity and beyond!]

sure let's change the goalposts!!! BTD fails so let's bring up another FDA possibility. It's better than facing reality. Why would anyone want to do that? Because then it might explain why the term sheet fell through. Either it was BTD dependent or there is something concerning about the B OM data.

If that is true- some bigger data problem, then the FDA will spell it out at the meeting.

Would IPIX bother to inform shareholders? They will have to say something about the meeting.