My understanding was that the FDA is more willing to accept drugs these days than they were in the past.  I think the FDA has been under pressure for “slowing down innovation” by going too cautiously in the past on NDA. 

This article suggests that times are changing at the FDA and they are more willing to experiment with new drugs despite limited information.  If the FDA can approve the drugs listed in this article, then Apabetalone is a no brainer: safe, almost statistically effective, with all the bio markers going the right way (I am assuming of course that the trial results are as good as the company’s press release and conference call suggested; I have zero knowledge if biomarkers and independent risk factors went the right way).

https://www.kqed.org/futureofyou/443087/fda-increasingly-approves-drugs-without-conclusive-proof-they-work