No Cashtrain,
If I am correct the passing of the patient would required PAA to advise the FDA of this.
So again imo the FDA would want to know the details around the passing prior to making a decision on the ODD application.
The passing of the patient also raises questions around did it in anyway have an influence on MT decided to leave.
Ann: Resignation of Dr Michael Thurn & appointment of John Clark, page-256
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