GREY:ATBPF - Post by User
Comment by
MrMugsyon Feb 20, 2021 9:18am
199 Views
Post# 32618090
RE:Next NR
RE:Next NRPragmatist wrote: My guess is Oten IND. Maybe this weekend; next week or two at worst.
At Biopub, Dan said that the company would be submitting the IND shortly after Christmas. Seems to have stretched this out a bit wrt sho-o-o-o-ortly. But definitely imminent.
From the corporate update, 11 Jan:
"As planned, we will be submitting otenaproxesul’s IND (“Investigational New Drug”) application to the U.S. FDA within weeks."
These two posts suggest sooner rather than later.
INDs are normally submitted prior to the commencement of clinical trials. ATE is well beyond this by light years. It has completed PH 2 under Health Canada auspicies. But it needs to get into the FDA system.
I think that that the company is attempting to combine the requisite IND requirements with the customary post Ph2 accomplishments, prior to securing FDA concurrence for PH 3. Makes sense given where the company is at this stage.
My prediction: IND review: slam dunk: FDA post PH 2 meeting : slam dunk. How could if be otherwise in consideration of what has been accomplished to date.
Just a thought!
Good point Pragmatist !
It makes sense we should expect that soon.
When he says "weeks," like he did with the Shareholder Update coming ... 4-6 weeks is right on the mark.
I wouldn't bet against that.