Replies to post #253757 on Innovation Pharmaceuticals Inc (IPIX)

[BooDog]

You, Karin and Froll make perfect sense.

Message in reply to:

Seeking EMA's advice probably means getting EMA's approval for a protocol based on FDA's requirements - usually a formality. IPIX (plus necessary funding partner) would benefit from running parallel trials, one in USA the other in Europe. It would not only save time but would ease cost and recruitment concerns.

KarinCA Member Level Wednesday, 01/09/19 11:30:18 AM
Re: BooDog post# 253738 0
Post # of 253756



FDA has approved them to move forward with two groups, both the aggressive and less aggressive chemotherapy. When looking at results of the ph2, the drug did better with the more aggressive treatment regimen. My guess is that they are seeking a trial just testing with the more aggressive regimen.

No telling what the thinking is. They may simply feel they'll get something to market sooner in the EU.

Either way, they can't do a thing without a partner due to lack of funds.

Posted by: frrol
In reply to: KarinCA who wrote msg# 253752 Date:1/9/2019 11:42:03 AM
Post #253756 of 253757


The company said it will "seek scientific advice from the European Medicines Agency to round out European Union program requirements for Phase 3 clinical trials."

It appears we're making sure our next Phase 3 not only meets the FDA's expectations but also the EMA's.