Replies to post #2221 on BioCurex, Inc.(fka BOCX)

[Kag]

Headache,
I will give you my opinion, and then we will see if Bocxman agrees or not.

Abbott has a semi-exclusive license to implement the RECAF blood tests into Abbott's Architect system. That is the extent of their license of RECAF technology. The new product, test, or implementing that Abbott decides to use may or may not need FDA approval. If it is classified as a Class I medical device it does not need premarket approval from FDA. It also does not require a 510k premarket notification. A Class II device requires a 510k premarket notification, and a Class III device requires a PMA (premarketing approval) along with possibly years of clinical trials for testing. Bocxman's "clinical indication" term just referred to what may or may not be required by the FDA. If Abbott is only developing the RECAF blood test technology into a Class I medical device, the time to market is short, and that is in our best interest as BOCX investors. kag

[bocxman]

Headache: Abbott will choose the regulatory strategy (PMA, 510k, BLA (down the line), Class, etc), and the FDA will officially choose the indication/label but Abbott's trial design will largely control the label. Biocurex will have nothing to do with any of it. They are just the licensor.

If ABT wanted to, they could initially pursue a trial design that (to use an extreme example) tests RECAF's ability to predict the recurrence of cancer over a 5-year period in patient's who've had chemotherapy. That is a legitimate indication, but would take a 5 year trial. That's an extreme example but you see what I mean.

What we're hoping for, and what BOCX has indicated (although they have no say whatsoever), is that ABT decides to pursue a 510k application for a prostate/lung/whatever cancer general screening test. In that case, they would simply have a lab test a few thousand known cancer and placebo samples and give them a yay or nay. That test would take months not years.