Ann: Rexlemestrocel Reduces Heart Attacks/Strokes/CV Death in CHF, page-468

if it true, Si commented that while in discussion with the FDA re design, the FDA where more interested in mortality rates. Many have commented in depth about the design... and made a piont about the numbers in the trial- and that created a bias toward the primary end points.. a mistake to me, maybe they weren't sure of moratlity rate outcomes to make that the primary endpoint but of course we don't know fully what influence in the FDA discussion were had, and what sort of pressure was there in selection a trial that had a number that was more suited to 'how much would the trial cost'"... .someone had to pay lots.
Don't know if a transcipt of FDA discussions on design could be had??? better researches than I?