re: Ann: Sirtex Completes SIRFLOX Patient Rec... "Important to...

re: Ann: Sirtex Completes SIRFLOX Patient Rec... "Important to correct you cafa. The FDA does not currently stipulate at what line of treatment sir-spheres should be used. A US physician is allowed to use them at any line of treatment. It won't matter a jot if FDA doesn't change the labeling in any way. The result of this study is only designed to convince oncologists to refer patients and to get sir-spheres into medical practice guidelines that dictate what physicians treat with."

I dispute this assertion, based on the posts I published. Unless you are suggesting that SRX will obtain a step wise increase in sales as off-label usage???

The PMA makes it very clear the conditions under which SRX may market in the US. Maybe my understanding of FDA regulations is wrong. Happy to be correct based on some evidence.