Is my memory off again? When did the FDA 'sign off' on BETonMACE
posted on
Oct 30, 2019 09:45PM
Something just occured to me....something I'd thought about previously then later forgot about.
Much has been made of the FDA requiring the inclusion of patients using Lipitor. But I'm now recalling that when BETonMACE started back in October of 2015, that the FDA wasn't at that time on board with the trial. Has my memory slipped a gear again? It has happened before.
Here's a link to a report by Zacks from Oct 2015:
https://finance.yahoo.com/news/rvx-phase-3-betonmace-trial-214500848.html
In that linked report it says: "On the other hand, we still believe that there are certain challenges that Reservlogix will continue to face such as proving the long-term hepatic safety of apabetalone use, and significant operating losses that are building up year after year. Additionally, we are still not sure what type of cardiovascular clinical trials the FDA and EMA will require of apabetalone, and we are still uncertain regarding the outcome of Phase 3 BETonMACE....
Currently, we believe the company is undervalued as it embarks on the Phase 3 BETonMACE trial. We do want to point out that data from this trial will not likely be available until mid-2018...."
I included that part about the anticpated conclusion date as I know that has been discussed before as well.
And here's a link to an article from January 2018, about the FDA granting protocol acceptance for the on-going BETonMACE trial:
https://www.resverlogix.com/investors/news?article=593
Finally here's another PR from when BETonMACE started that says this:
There's no mention of EMA or FDA at all in the above linked PR....so help me out please. When this trial started, was the inclusion of Lipitor something that the FDA asked for, but still did not lead to FDA recognition until some 3 years (give or take) later?