It appears from the presentation at the ISOBM that 2 important things happened which signal to me that they are ready to demonstrate to the FDA that RECAF is ready. First, was data collected by Biocurex as well as independant data from Abbott in collaboration with samples from Munich. Second, was the accuracy attainable with multiple serum collection tubes meaning it is equally proficient on most other analyzers. With all this data collected over a 2 year period I would think it is sufficient to apply whichever way is deemed required by FDA standards. You may be correct in assessing that there may not be a predicate for a 510(k). This is unique and that is what will propel us from obscurity. My point is that Abbott is well rehearsed along the lines of getting the proper registration and approval, but there is enough data to apply now. There are no more trials necessary, so what is the hold up? I know that Dr Moro is careful not to cause any turbulence with Abbott, so he will not jeopardize his relationship with them. Abbott is a goliath and probably the best partner we could have hoped for in terms of worldwide distribution. The laws in the US are significantly different than in other countries, so maybe we'll see a launch outside the US first. All I want to see is a royalty payment and some revenue to legitimize this entire operation. I am at peace with the fact that this is now a sound investment, unlike earlier this year when no one knew what was happening at Abbott and how this would effect the relationship or progress with RECAF. Now that we know Abbott is definitely on board, but has not yet submitted to the FDA for approval, maybe Dr Moro won't close the deal with another licensee until Abbott is totally committed. He may feel that Abbott is watching closely to see who we are about to license to, so they will not bear the full burden of the FDA approval process alone. If it was an exclusive we would probably see the application already submitted. Obviously, this is just my opinion, but may answer why Abbott is very quiet and secretive. The fact that the last press release was a joint press release was a big deal, but Abbott did not comment to the media or its shareholders on their website about there 96% accuracy of detecting cancer with RECAF.
AI
