>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.
It is also a garbage idea because nobody would enroll in the Phase III, which has a chance of placebo, if they could get into the CU program, which has zero chance of placebo. They would simply wait and wait for their shot at the CU program, eventually going beyond eligibility guidelines.
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