my (limited) interpretation of the verbiage was th
Post# of 148109
a) directed by FDA, although within their written guidelines, still as a form of CYA to cover past egregious exclusions of CYDY which prevented lerolimab use from addressing public health needs, and/or
b) a sort of mea culpa from JL on behalf of the company's past sins, and to continue to build his credibility and relationship with FDA
functionally a nothing-burger, but we live in a world driven more by perception-management than practicality