Where we at?, page-597

Hi Dungiven,

I had a quick look and I can see Bene's US DMF number, it's active and registered.

Here is a link:

https://www.fda.gov/drugs/drug-master-files-dmfs/list-drug-master-files-dmfs

Look up the number 21248 in the excel doc in the above link.


There are a handful of others that have an 'Active' entry as well (...and one that has Pentosan PolyFulfate Sodium ?!) (Must be a typo?) but the rest are for IC or Vet formulation. We will be the only ones that have it registered for Humans and for OA. You'll recall that it was the FDA that said to Paul that we are only to use the bene formulation, this was stated at our PRE IND meeting a number of years ago. (8th April 2020)

Soon after that PRE IND meeting happened Paul had said that line verbally in a presso, I remember that one like it was yesterday....but it was almost a year later when I was re-reading thru the recent announcements at the time that I was surprised to also see it in print. (I was surprised as I did not remember the ASX announcement closer to the time it was published).

Here is the key statement:




Reference:https://app.sharelinktechnologies.com/announcement/asx/1ec4e6b18831d5f5b83118e072684730