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.
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