Ann: Appendix 4C & Quarterly Update, page-72

Another thought that just came to mind that might help you - In their Quarterly Report, PAA have made the 'unsubstantiated' claim that "As the patient was not on study at thetime, their death was not formally notified." I suspect, and this is just my ignorant, unsubstantiated opinion, that if the death is not formally notifiable to PAA, then there would be no obligation for PAA to report to the FDA. Simply put, the death is not associated with the use of MPL - it is the result of a terminal illness and the person was not on any trial of the drug at the time. Harshly put, it's like if one of the patients got hit by a car - not notifiable.