Replies to post #337 on BioCurex, Inc.(fka BOCX)

[bocxman]

HEADACHE...
When you say "early detection," I take it to mean using RECAF as an indicator for the later development of cancer. THAT is the only "early detection" that would require a lengthy trial like you're describing. BioCurex discusses that type of "early detection" indication in their 10-K...they mention that some of the samples identified as cancer with histo have been the earliest stage of cancer or something to that effect.

When I say "general screening," I'm referring to the exact same manner that PSA/etc is used. With PSA & the other "general screening" markers... you first take the blood test. If it's positive, you do a body scan to determine where exactly the tumor is, how big it is, has it spread, etc. Once the scan is complete, you do a biopsy to get final confirmation that it's cancerous and other info about the tumor. Then, you make a decision on treatment (ie; chemo, surgery, radiation, etc).

So you see, there is no possible way that the "general screening" indication I described above would require a lengthy trial, and that is the blockbuster indication. It's a simple positive/negative on a group of *known* cancer samples. In fact, all the major cancer markers have been filed with the FDA under 510k's (no trial at all), & Dave Gentry says that the company expects to go the 510k route with the FDA but I think there is a good chance they'll end up needing a PMA (which requires a formal trial, albeit a very painless one compared to the nda process for drugs).

If Abbott goes the 510k route with the FDA, I can see why BOCX told longterm 1 year until commercialization after the Abbott deal was announced. There is very little process involved (for instance...BOCX got 510k approval for Histo-RECAF -- they just submitted the internal study data they've been showing us and the FDA accepted it).
If Abbott goes the 510k route, we would literally get approval within weeks to months rather than 6 - 12 months if we went the PMA route (6 - 12 months from the time Abbott integrates RECAF onto ARCHITECT and begins the regulatory process).