Replies to post #47519 on Biotech Values

[mouton29]

<<The exact wording of the question after it was changed was, "Is there substantial evidence of efficacy?">>

Further, it is quite clear that the FDA was attempting to state the standard for FDA regulatory approval -- they said so. One difficulty is that no guidance was given as to what the words really mean (not that the FDA ever does give explicit guidance to the panelson this point), perhaps because there is no universally accepted meaning. Does it mean, not quite established beyond a reasonable doubt, or something less, or something a lot less.