HER2 Support Group Forums - View Single Post - FDA staff saying data supports fast approval for perjeta in early bc

phil · 09-10-2013, 01:39 PM

how about FDA appr. of Perjeta for Stage IV ? How many yrs ? How many unnecessary deaths ? Without those who volunteered for Phase 1 toxicity / safety with this drug , when it was just a bunch of ltrs and no's, and noone knew if it might kill you , there would be NO Approvals at all ! Without FDA appr., ins. co's and hospital IRB's are denying it to Stage IV's right now .
Pres. Obamas' FDA continues to operate with 20th century regs in a 21st century world , and Stage IV pts are dying every day ... infuriating- and even more infuriating are " advocacy " grps like NBCC and BC " Action " that blindly support them ! BC " Action " sits on the FDA advisory board that revoked Avastin, rejected T DM-1 , and has dragged out , piece-meal appr. of Perjeta for yrs ! , as a " pt. rep " . They don't represent Stage IV Rights !

09-10-2013, 01:39 PM	#2
phil Senior Member Join Date: Nov 2010 Posts: 393	Re: FDA staff saying data supports fast approval for perjeta in early bc how about FDA appr. of Perjeta for Stage IV ? How many yrs ? How many unnecessary deaths ? Without those who volunteered for Phase 1 toxicity / safety with this drug , when it was just a bunch of ltrs and no's, and noone knew if it might kill you , there would be NO Approvals at all ! Without FDA appr., ins. co's and hospital IRB's are denying it to Stage IV's right now . Pres. Obamas' FDA continues to operate with 20th century regs in a 21st century world , and Stage IV pts are dying every day ... infuriating- and even more infuriating are " advocacy " grps like NBCC and BC " Action " that blindly support them ! BC " Action " sits on the FDA advisory board that revoked Avastin, rejected T DM-1 , and has dragged out , piece-meal appr. of Perjeta for yrs ! , as a " pt. rep " . They don't represent Stage IV Rights !