https://www.entrestohcp.com/paradigm-hf-clinical-trial?site=SO052606

Entresto was approved by the US Food and Drug Administration (FDA) in July 2015 to reduce the risk of death and hospitalisation in heart patients classified under The New York Heart Association (NYHA) class II-IV, approved to decrease the risk of heart failure in those with reduced ejection fraction (outbound pumping of blood by heart).

https://www.nejm.org/doi/full/10.1056/NEJMoa1409077%EF%BB%BF

I believe this was the largest clinical trial conducted by the FDA with over 8,000 patients

The trial  was stopped early after a median follow-up of 27 mos. because the boundary for an overwhelmimg benefit had been crossed.

Under the first link above, estimated GFR trial design parameters are listed:

                    < 54    24.7%

                     54-79  48.9%

                     >79     26.4%

Apabetalone trial design requirements may be similar to the Entresto trial in numbers and duration.

This is a substantial committment for any BP - anxiously awaiting announcement of the RVX partner(s).

RVX Shareholders are looking at possibly another 36 mos to get this drug on the market.

This is a new class of drug - the FDA most likely is insisting on a large sample.

Let's get it done - once and for all - the right way - and then roll out the star factory.

Looking for a buyout now with royalties to come  - It's time for BP to take over this gem.

GLTA

Chicagoest