[phil]

Nancy, while they "debate " possible exp access exclusions , what about applying for comp. use ? you can tell how ticked off , to put it mildly, that we are w/ all the bureaucracies stumbling , bumbling over such a miraculous drug ! One of our activism " planks " will be Flexible Treatment for Late Stage IV Pts , shorter washouts, keeping folks in trials even w/ " mixed response ", and for the pharma co's : If you think your drug is good enough to be considered for acc. approval, its good enough for comp use to late stage iv pts. If FDA rejects acc. appr., you finish the phase III trials that they want. Hopefully in the future we will have a 21st century FDA that can help get trials in that category to be reviewed more quickly, not 2 + yrs like This FDA with T DM-1.