Replies to post #253735 on Innovation Pharmaceuticals Inc (IPIX)

[BooDog]

I'm thinking they'll go for duel trials, both in the EU and in the U.S.
The wording "seeking advice" floors me a bit. They should already be familiar with the landscape of how to move a drug through the regulatory process in the EU. And I believe they are. The potential partner/s they seek or have a tem sheet with would certainly be familiar. So, if they're just asking, "how do I fill out an application", well, that would just irk the heck out of me.

Get the partnership and funding and kick this puppy in gear!!

Show me the money $IPIX!!

[PlentyParanoid]

"A Phase 3 trial in Europe wouldn't act to secure FDA approval for distribution in the US, would it?"

Yes it would, as long as the trial is run according to FDA approved protocol and FDA is able to validate trial data with onsite inspections. The reverse is generally true for EMA approval of a drug based on a trial run in US. FDA has even granted initial approvals based solely on trial(s) conducted outside US. Votrient (pazopanib) is one of those drugs.

Readable overview about FDA's expectations for acceptable IND and non-IND trials conducted outside USA.
https://www.fda.gov/downloads/drugs/newsevents/ucm441250.pdf