[Paula O]

My brain is busting at the seams with information (not that I understand it all, that's for sure)! It was an excellent symposium.

Welp, Phil-- I spoke with some oncologists, breast cancer advocates, Gennentec reps, and sought out some media folks about the FDA's denial of TDM-1's accelerated approval. The two words I heard most often in response were "Due Diligence". Many people expect TDM-1 will be approved in early 2013, probably in February, and feel confident that it will be approved once the FDA has done it's job fully examining safety and efficacy. After a special meeting of breast cancer advocates with Debbie L and a research oncologist (Dr Sara--forget her last name? Horwitz? presenting on Tdm-1 (Project Lead Advanced Topics for advocates and those a part of the Alamo Breast Cancer Foundation ) I stood up and shared frustration over the delay while many Her2 positive patients were experiencing disease progression and death and not able to access a drug which has strong proof already that it is safe and effective. Honestly, it was rather embarrassing to me that I got choked up and started to cry at the end of delivering my passionate little speech to the group (a summation of what you shared here) about those in urgent need of early approval of TDM-1 but I guess people got the message that these are real women in tough straits right now waiting for approval, some of them dying without the drug after exhausting other available options.

Phil, I am going to PM you contact info for one of the media people I spoke with briefly (a Chief Honcho assistant director at the symposium ) if you want to tell him Lorraine's story.

Paula