BioCurex, Inc.(fka BOCX)

[Gold Seeker]

I think anything the company has said indicating a possiblility of a 510(k) is just shareholder fluff. What Dr. Moro has stated is that some think it can be done with a 510(k), others think it will require a PMA. You look at it logically and there is NO predicate test for RECAF. No one is testing for anything similar and the problem exists with wasted time. If you try a 510(k) and it fails, you have wasted at least 90 days. You cannot be running concurrent clinical trials because the FDA has to be involved in the trial setup. If you are planning trials, the FDA will say fine, "I agree with you plan for the trials and BTW, you can forget about the 510(k). Wny are you wasting our time?"

I am very familiar with how the FDA and biotechs proceed and I would say 99.9% a PMA, the .1% a 510(k). If you get down to basics, the employees in the FDA are more interested in covering their butts than advancements in medicine.