re: Ann: Sirtex Completes SIRFLOX Patient Rec... If you have a good read of this clinical investigator flyer it should be as clear as mud LOL
http://www.sirflox.com/files/user/SIRFLOX-trial-summary_US-167-MAR-LEAF_rev-2-190110.pdf
the fine print of the flyer
"This information concerns a use that has not been approved or cleared by the Food and Drug Administration (FDA).
This clinical investigation is being conducted in the USA under an Investigational Device Exemption (IDE) issued by the FDA. SIR-Spheres microspheres are indicated for the
treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) of FUDR (floxuridine) under a Food and
Drug Administration (FDA) approved premarket application (PMA)."
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