[phil]

This FDA seeks no input from the very Survivors they purport to be helping. Besides their un-scientific statement about pts " not having exhausted all other options " , they insisted on comparing t dm-1 to tykerb/xeloda . You Stage IV Survivors already knew that combo was inferior in 2010. Now nearly 3 yrs later , This FDA is going to tell you what you already knew. after they craft a defense of their actions . While hundreds more go past the point of no return. And they are un-touchable , Congress told us so in 2011. Their superiors in Sec. Sebelius' office told us the same earlier this yr. They don't care how good the drug is . This is where a good investigative journalist comes in. to prevent this from happening to another drug, to help us empower Stage IV Rights. we want a place at the drug approval table. ( Sen Kay hagan , NC pushed alaw to overhaul fda approval process, but there's no place for stageiv advocates ) I told This FDA , " In the end it really IS all about us ! ".
Tykerb was given early approval in 2007, under the previous , business -friendly Admin. Does anyone know how many yrs that took ? Un-like tdm-1, when was the trial process stopped ? What was the reasoning by That FDA ? Did they put a " Black Box Warning " on it ? Like This FDA is doing ? Like we dont know chemos have s/e , duh !!
We need consistency from Admin. to Admin. This FDA was hell-bent on punishing drug co's for not finishing trials , and wanting new , longer testing - using Overall Survival stats vs. the previous gold standard, Progr. Free Survival or time to progr. We can'tet them continue to ignore us , patronize us !