According to my people at Genentech, the drug has no systemic toxicity itself and is more effective than either Herceptin or Taxane. The box warnings are standard and reflect the incoming conditions of the study group- all of whom were people who were very ill and heavily exposed to chemo. The beauty of TDM1 is it goes only to the tumors. There is no hair loss, no nausea. Ongoing studies as first line single agent therapy will be completed in several months. Genentech expects the drug label to be officially expanded by the end of the year. Meanwhile, it will be used off label. What is 5% of $9Billion?