Re: Pondering the biomarkers...
in response to
by
posted on
Nov 22, 2019 10:21AM
Deb ... to your point, we seem to know more and more that apabetalone works well in sick patients, and brings phenomenal benefit to certain groups of them.
I think some of your (and others') questions are perplexing, because they leave questions given some of the data. Science communities, clinicians, and perhaps even the FDA will want to answer these "questions" before feeling good and fully endorsing apabetalone. My concerns pre-TLD/FLD, were study design for proving selected endpoints, appropriateness of endpoint selection based on prior studies and data, ... and "bogeys" - what will come up in the data which is apparently conflictory with previous theories and within results which the curiosity and critical nature of scientists will need to resolve for feeling certain to the typical levels needed for advancement and and "fully open" door and green light? ... we still have some questions to answer within the science imho ... despite a nearly "proven" clinical value and safety record.
Hopefully the RVX science elves are hard at work toward a nice Christmas? TThe nature of these things take time and scrutiny, getting closer. Hopefully yhe FDA and BP's recognize the clinical benefits, and safety profile, and offer a near term option while the drug, MOA, and other things are becoming more fully understood over time and experience (strong emphasis on "apparent" safety profile here).
I would hope for "break-through" status to help some classes of very sick patients now due to apparent clinical value ABOVE current SOC, the safety profile, with additional study performed along the way. Aside from my investment interest, this is a very interesting medical/business case study forming up in my mind.
Cheers!