Antibe Therapeutics Inc(Pre-Merger) ATBPF

Approved for Phase 111 in the US

[nozzpack]

 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

[MrMugsy]

I 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]

U know nothing about what the company thinks. There are many issues related to anomalous and transient LFS from flawed patient selection to idiopathic presents. Surely FDA has never genuflected in the past..

[MrMugsy]

hahaha. that's pretty agressive NOZZ. you say that with such confidence Who's genuflecting?

[muto412]

You're right they won't 'genuflect'. However, Dr. Stauffer has experience with the FDA...he has an understanding of the space and can provide solid guidance on FDA procedures.  "Dr. Stauffer practiced frontline medicine for a decade, including eight years as a US Navy general practice physician. He then joined the US Food and Drug Administration (“FDA”) as a Medical

[3burtc]

Yes it does prevent phase3. You see friend if they don't figure out what went wrong. Phase 3 will fail and there goes 60 million. So many questions now about mgnt, especially Wallace. These guy's have lost the confidence of the investment community and it will be tough to regain that trust. I wonder what Nuance thinks? They put up 27 million cdn and now this?

[Daydream2]

Also what does Bloom & Burton Co. thinks of all this. A few of their tens of millions in investment have evaporated.

[WalkOverTheStrt]

It's a numbers game to the BPs and investment funds.. Do you really think they had everything at stake on antibe.... Claculated risk and with it many other plays that will pan out. Also Antobe's story is not over and far from it. Delayed yes but HS2 likely has a place in the medical world...