Please. There was no original plan to rewrite. RDGL presented an outline of an animal test plan at May 20 meeting. At that meeting FDA requested a detailed animal test plan and what they expected it to contain. RDGL drafted a detailed plan and per June 28 update tweet gave draft to JHU to review. We now know per late August update, JHU has since had to verify they could actually accomplish plan before commenting further. And per that August update it remains uncertain JHU can grow the rabbit tumors to sufficient size.
Per primary literature Kayak cited in prior comments, growing these rabbit tumors to sufficient size is a trivial matter to someone well versed in doing so. So FDA views this as a trivial matter. So when RDGL comes back with detail plan more than three months after FDA request, it sure doesn't look like RDGL is in any hurry.
We now know they delay was because JHU isn't well versed in the rabbit tumor growing art yet. What JHU brings is already certified in IsoPet and they have the veterinary PET scan equipment to verify containment per plan. FDA reviewers won't know background reason for delay until they actual review what RDGL has sent them.
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