GREY:ATBPF - Post by User
Comment by
MrMugsyon Aug 13, 2021 3:09pm
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Post# 33701955
RE:Approved for Phase 111 in the US
RE:Approved for Phase 111 in the USI don't think the company believes it's patient specific - way past that - but let's see what the September's update includes.
If the drug is more potent than even they expected, they need to find the lowest effective dose.
You wouldn't want to go to Phase 3 and run into an FDA stoppage.
nozzpack wrote: 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