"Apabetalone’s strong safety profile, along with the latest published results, allows us to move this novel therapy into a subsequent study under US FDA granted Breakthrough Therapy Designation to enable a New Drug Application filing.

A subsequent study enables an NDA filing?  Presumptuous statement or hint that the subsequent study is a Phase 4 trial as a condition to labeling approval?

I also question the following statement for a previous News Release that is now part of the company description in all NRs:

"Apabetalone is the first therapy of its kind to have been granted US FDA Breakthrough Therapy Designation – for a major cardiovascular indication – to help facilitate a time-efficient drug development program including planned clinical trials and plans for expediting the manufacturing development strategy."

Why the need for expediting the manufactoring development strategy if we are an entire trial period of time away from an NDA filing and eventual labeling?

Things lately that make me go hmmmmmmm...