>A CU dictate would only be logical if it was also mandated in place of surrogate approvals…<
Agree.
>…a point that should be obvious from my myriad posts on this topic.<
It wasn’t obvious to me.
>…DNDN couldn't possibly manage giving away a couple hundred million dollars/yr. for the next 3 yrs. until 02b is done, and that's about what it would take if all eligible patients requested compassion.<
If the drug is as promising as some people think, surely there are ample sources of capital to complete the program. In any case, that’s not the FDA’s bailiwick.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”