Approved for Phase 111 in the US U.S. Food and Drug Administration (“FDA”) has already cleared the Company’s Investigational New Drug (“IND”) application for otenaproxesul, in development for the treatment of osteoarthritis pain.
This enables Antibe to undertake human clinical trials in the U.S.; as previously announced, Antibe anticipates initiating its Phase III program later this year.
They provided a ton of a comprehensive package of preclinical and clinical data in a submission comprising more than 55,000 pages.
So, this minor issue does not prevent phase 111 clinical trials from proceeding in the US.
It is merely precautionary and may be nothing more than patient specific issue