Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

"IPIX could be looking into doing the trial in Europe".
A Phase 3 trial in Europe wouldn't act to secure FDA approval for distribution in the US, would it? Or vice versa?
Are they talking about two separate Phase 3 trials?

How are the last two paragraphs of the PR connected, or are they?

"The Company recently completed an End-of-Phase 2 meeting with the FDA, paving the way for pivotal trials of Brilacidin oral rinse for HNC patients receiving chemoradiation. In Phase 3 trials, Brilacidin will be evaluated in patients receiving aggressive chemotherapy (cisplatin administered 80-100 mg/m2 every 21 days) and in those receiving less aggressive chemotherapy (cisplatin administered 30-40 mg/m2 weekly) as part of the chemoradiation regimen.

In its goal to build a world-class clinical asset across the Brilacidin franchise, with the indication of severe OM a Company priority, Innovation Pharmaceuticals is preparing to seek scientific advice from the European Medicines Agency to round out European Union program requirements for Phase 3 clinical trials."


Would the Company need to "seek scientific advice from the European Medicines Agency to round out European Union program requirements for" a Phase 3 clinical trial to be held in the US to assure that their protocols would be adequate to satisfy EMA requirements for distribution in Europe based on FDA approval?

OR would they be seeking "scientific advice from the European Medicines Agency to round out European Union program requirements for Phase 3 clinical trials" to be held in Europe?


The meaning of that last sentence must be clear to someone...obviously it's not clear to me.