hahahah! You are that far behind sunshine.
the type D meeting was to review the adrenal function monitoring in the dosing (stage 1) arm of phase 3 and the pre clinical trial work completed on this subject matter only, that was agreed to be completed due to the vacuole that formed in 1 rodent back in 2020 when the company was applying for the 5052b pathway to market. The vacuole is a relatively rare but well known furphy in rodent physiology in lab trials, not attributed to the drug molecule.
Paul has addressed the his too many times to give you a reference. Pick any Q and A section in any recent webinar and it’s bound to come up.
Ann: PAR to present at NWR Healthcare Conference, page-36
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