I like this part of Dr Shannons' comment, clearly composed after having read the FDA input;
"Can we not look initially to a system of ongoing reporting of outcome efficacy outside of clinical trials as a means to get these treatments to patients who need them, rather than asking researchers to come up with a new means to quantify batch quality."
As in get it out there, we can fix some things later on.
FDA ODAC Meeting Material discussion analysis, page-220
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