Re: Amarin Stock Halted pending FDA meeting today
posted on
Nov 14, 2019 02:57PM
"What if BETonMACE data shows the FDA that low trigs and CRP are not correlated with improved MACE. Does the FDA just ignore that going foward?"
There is no currently available evidence that apabetalone modulates triglycerides, so BETonMACE should have no relevance to the triglyceride hypothesis. Maybe BETonMACE will hold some surprise effect on trigs, but I'm not expecting it.
Apabetalone Phase 2 data has been somewhat inconsistent in the hsCRP department. We'll have to see what BETonMACE shows. However, a much more focused CANTOS trial to target the IL-1B-->IL-6-->hsCRP pathway has provided the best evidence to date to validate the inflammation hypothesis. Even if both apabetalone and Vascepa show reduced hsCRP in their respecitive trials, BETonMACE and REDUCE-IT, both drugs modulate so many different pathways simultaneously that neither drug trial will be able to ascribe its benefit to any one particular pathway.
BDAZ