Re: Back to the FDA
posted on
Oct 04, 2019 06:54AM
"Safety profile of RVX [was] a huge hurdle. The one main point more than anything else which has me hanging on. Well that and it is administered orally and manufacturing cost are cheap. Not much downside on those three points"
I agree 100%. We'll of course need to wait for the full data to see the safety and tolerability data ourselves. However, from the top-line news, they stated in a major bullet point that "Apabetalone demonstrated tolerability and safety." That is huge. For a drug that could potentially be used for treating a myriad of conditions beyond cardio, it needs to be safe. The greater than two years median dosing in BETonMACE with 2425 patients will give the largest data set to date to prove its safety. Plus, your points of cheap and orally available are extremely important too.
I actually re-read the top-line news a couple more times over the past 24 hours. Aside from missing the primary endpoint, it all seems extremely positive. Of course, one might say that they needed to put on a good face. But there was so much excitement in that top-line announcement about the news yet to come from BETonMACE. To be continued.....
BDAZ