Antibe Therapeutics Inc(Pre-Merger) ATBPF

We are still in the pre-clinical stage.

[Rarbar99]

The FDA processing is far more rigorous and strict than it is here in Canada. In the eyes of the FDA, we are still in the pre-clinical stage. Not even stage 1. 

it's important for everyone to know this.

[MrMugsy]

I don't think it's that simple. With all the data that's been collected - and all the data that is being collected - the FDA will be clear about what they still want to see. It all depends on what ATE finds and the direction(s) they'd like to pursue. Likely - a smaller P2 will be required before a P3 in one aspect. But, I also see an opportunity for a P2/3 in a different aspect

[themagicbox]

Hes on ignore but I got to see his comment through your reply. Funny how he says that without a shred of evidence. Any FDA stage classfication document to back this nonsense comment?

[Candyswanwick]

Otenaproxesul isn't considered a preclinical drug. Lol. 

[Rarbar99]

  Tell that to Antibe. They released this report back in March 2021: https://antibethera.com/news/antibe-therapeutics-receives-fda-clearance-of-ind-application-for-otenaproxesul-for-osteoarthritis/ The FDA does not care what-so-ever about Health Canada. If Antibe wants FDA approval, it needs to go through Ph1, Ph2, Ph3 and NDA all over again. Right now they're at the very

[StockingUp21]

CAN WE GET MUGGY OR ANOTHER EMPLOYEE TO CLAREIFY

[Candyswanwick]

Dude did you even read the article you posted? I'm concerned that you don't know how to read.

[Candyswanwick]

I'll try to be patient... "Antibe is a clinical stage drug company" is literally the first sentence. They then go on to say they have given clinical data to the FDA. If Otena is a preclinical drug, where did they get their clinical data to give the FDA? Do you know what clinical means? 

[Inthepez]

Lmao!!

[muto412]

Otena is not a pre-clinical drug. A pre-clinical drug has never been tested in humans. We have dosing down to 75mg in humans which showed cox inhibition. This phase 1 trial showed it was safe up to 250mg/day for 14 days.  Please read about clinical trials.  https://antibethera.com/news/antibe-announces-completion-of-phase-i-studies-of-atb-346-and-an-update-on-its-validation-studies/