[phil]

My primary focus roght now is to get t dm-1 approved. It would be " nice " if Genentechs top execs would give compassionate use to Stage IV Her2 pts in the meantime. They know what a powerful drug they have.
Then we can focus on changing The Crooked System. get rid of Dr. Pazdur and his top advisers. They are blind scientitists. So invested in being " scientiific " that they are " un-scientific ", so " rational " that they are " irrational ". T DM-1 will be their stumbling block. Science is known for its blunders as much as its successes.
I havent fully thought out systemic changes, but I would start w/ giving Stage IV pts Flexibility, expanded access at all Phase of testing , especialy Phase III , 14 day wash-outs to get in, flexible tx planning while your in the access program. , give extra time for counts to rebound, lower or raise doses , etc. Do your rigid trial testing with earler Stage pts., . Sign Informed Choice Consents. Take away some of This FDA's power to decide For Us " Benefits vs. Risks '. We Decide !
Then I would focus on this Racket called " Single Pt. Access, or so-called " compassionate use ". Right now its a Con, a Cop-out by This FDA. They wont talk w/ Pts, tell us " Have your doc contact the pharm. co, if the co. says ok, have them contact us ". Putting us at the mercy of Global For-Profit Companies ! And docs who are conservative by training, reluctant to take risks, relutant to challenge Big Pharma, or This FDA . They'll be black-listed from trials. Comp. use is a Fraud !
So, I say change the law, get an FDA that advocates for US, The People ! You will talk to us, and if we are Stage IV , you will approach the Global Mega Corporations for us !
As far as drugs like this G... whatever, I dont know what the pt. death rate was, I do know what the death rate for CML was not so many yrs ago, 100% or close to it ! many drugs have saved lives through accelerated approval, some have not worked. I go with what Lorraine said at the Rally " Give Us a Chance ", an informed chance !