[phil]

re above : We are not anti -govt., etc. We are Pro- Stage IV Survivor .
If I were at the Symposium , I would seek out media , and give them the following :
Reasons To Investigate This FDA's ( Mis ) Handling of T DM-1 ;
1. This FDA Rejected Accelerated Approval in 2010 for a drug that had a" 38 % COMPLETE or Significant Response " for 6 months or longer. Isn't this one of the strongest statistical responses ever seen for one of the deadliest cancers ?
2. Doesn't T DM-1 have some of the fewest side efects EVCER in achemo?
3. In 2010 This FDA stated that it rejected T DM-1 partly because " patients had not exhausted all options" . Lorraine and THOUSANDS of others had ! They never interviwewed a single patient !
4. This FDA then mandated that genetech complete a 2-3 year trial comparing T DM-1 to an inferior drug , Tykerb. Tykerb was given acc. approval in 2007-note the date - previous Admin. We want consistent policy involving Stage IV Lives from Admin. to Admin. !
5. After rejecting accelerated approval , This FDA twice rejected Genentechs' request for expanded access data to count towards appr. Why so rigid ?
6. This FDA already knew the breakthrough , revolutionary nature of this " Smart Bomb " drug , yet has made NO attempt to consider early review of EMILIA data the past TWO and a Half Years ! Again, why so slow ? They had the original data from 2012, preliminary EMILIA data since May, , now the Final Data since August !!
7. The Assoc. Press reported at ASCO in June that this " Dream Drug " " just missed the RIGID criteria for immediate approval " . This FDA couldn't bend arule for the best breast cancer drug in 15 years ? One where SIXTY-FIVE PERCENT of the EMILIA Pts getting T DM-1 have lived TWO YEARS SO FAR , and counting ??They coudn'yt think justa little " outside the box " in 2010 , or now ? Even appr. in June would have saved hundreds of lives .
8. Why does This FDA sneak out Press releases on Fridays ? They had a sham hearing in June 2011, revoking Avastin, but the Commissioner waited until the Friday before Thanksgiving to release her final decision . 5 months ! On Friday, June 8th of this year they sent out a Press Release at 8:30 PM EST ?? , giving only conditional appr . to Pertuzumab , denying it to Stage IV Survivors to this day ! Are they ashamed of their actions ? They sure act like it , and should be ! Investigate This FDA !