Even if the FDA became aware of the person who wasn't on a trial passing away (PAA do not need to advise them), I can't imagine it. As I understand ODD - one just has to show a good safety profile and some indication the drug provides a benefit. Our Ph 1 does that in droves. IF there was a suggestion that MPL somehow contributed to this patient's death, THEN the FDA would be interested. Of course we don't know the precise details of the bullbars MND sufferer that passed, I doubt it was caused by MPL in any way.
Ann: Appendix 4C & Quarterly Update, page-63
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