the significance of this development is that it proves the “criminal” element is out of USRM case and it’s just a matter of negotiation and the very basis for mediation!
heard constantly “processing with enzyme” was the issue but then same FDA accepts an IND on those lines! could it be that the real contention between FDA and USRM that one asks for a full reset and start from zero giving up their years of studies and the other says we are ready for final approval! the defense would argue saying the “drug” definition wasn’t clear then so move on!
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