Re: DECLARE TIMI-58 w/ prior MI as BETonMACE proxy?
in response to
by
posted on
Mar 28, 2019 02:58PM
"My question is this, can the topline result for the primary endpoint also possibly described as being (and I hate this word), inconclusive? If so, who knows what can happen, if anything. Apabetalone then possibly languish in the clinical trial netherworld and then gradually fade from view, or be of some use but not in the way we all hope. Statistically, it would seem that the primary endpoint will be achieved or it won’t, there is no ‘in between’. Right?"
Paladin.....great question that I don't have a definitive answer for. We talked about this issue a few weeks ago and I wrote:
"One lingering question I have is whether success in the primary outcome for one of the pre-specified analyses would be enough for approval? In the event that BETonMACE fails to achieve significance for the primary outcome in the total population, could statistical significance with a pre-specified analysis be enough for marketing approval? The obvious one is the rosuvastatin + placebo vs. the rosuvastatin + apabetalone. But there are many other pre-specified comparisons too."
So perhaps some of the pre-specified analyses of the primary 3-point MACE outcome could achieve statistical significant and save BETonMACE in the event of non-significance in the total population. But I still don't feel like I understand this process well enough. In addition to wondering whether the FDA/EMA would approve apabetalone under this scenario, we also don't know whether these pre-specified analyses would be available at the release of top-line data. If not available at top-line, there could be quite the roller coaster ride in store for the share price as subsequent pre-specified analyses of the primary outcome are reported. Hopefully, BETonMACE achieves the primary outcome in the total population with statistical significance so we won't have to go down this road!
BearDownAZ