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Old 06-11-2012, 04:05 AM   #25
phil
Senior Member
 
Join Date: Nov 2010
Posts: 393
Re: Pertuzumab: Today's The Day

I hear that gen. says they have enough for anticipated present demand.
I suspect This FDA - Dr. Pazdur and his top aides in the Oncology Drug Product Review Division show no signs of real concern for Stage Iv pts. They are continuing thier quest for Testing over saving Lives.
I believe that they purposely released the news late on a Fri. night. Some wierd attitude towards Gen., and /or accelerated approval as practiced in past. Wierd , because complete pert approval should be a no- brainer, w/ a minimal s/e profile , based on herc. hx. I told you about my experience at Avastin hearings, that " Re-Li" Associates little " feast " was down a back hall, next to aroom they had set a side by FDA . To me , it tells who has The Power in DC , and It isnt You ! Speak Up ! Our reps should be grilling This post 2008 FDA about Pert right now ! Write them !
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