Dew
That was the article I was referring to - it fails to give any reason why the trials, meeting the primary endpoints, yet did not meet with the FDA's pleasure. It mentions trends against safety (relative to placebo ? am not 100% sure, but I think so); and so I had suspected safety as the issue (on the other hand, CABG is not a "safe" predicament).
And so are you "reaching" for your conclusion here, that the FDA did not like the way the trials were run ? Or do you have other hearsay ?
Example: if CABG was the target in the late 90's; why would the target change ? to save $$$ ? hardly, the size of the original trials were not too large.
TiA
"....on the biotech battle-field, you need some élan...."