The following are questions that have been posted to this discussion forum and have been answered by Dr. Moro. They have not been edited by AGORACOM. Initially we had stated that we would respond to your questions within two weeks. That statement was made because at that time we did not know the volume of questions that we would receive. Obviously, we will certainly try to get answers to your questions as soon as possible. We regret any inconvenience or frustration that statement may have caused.
1. BioCurex has received numerous questions from shareholders regarding Abbott’s license status.
The amendment of the agreement was duly signed shortly after it was announced. An oversight resulted in the text of the 8K stating that the agreement was ‘in principle’ and not that it was made ‘effective’. For further clarity, Abbott has not issued a notice of cancellation of the licensing agreement, has not issued any notice of return, and it continues to be a licensee within the amended terms as described in the 8K form of March 20th 2008
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2. The reasons for the July 2007 Financing
The main reason for raising $3M in one shot, was the decision to move on to develop therapeutic applications based on RECAF. This decision was based on the following points:
(a) Abbott Diagnostics was being acquired by General Electric (our licensing agreement was transferred to them). Abbott’s was moving forward, with positive results – as later shown in the presentation at the ISOBM congress in September - and it was expected that GE would be continue and accelerate bringing the product to market. This would relieve BioCurex of a great deal of effort to help develop the chemoluminescence assay required for Abbott’s automated instrument.
(b) The way the collaboration with Abbott was advancing, we thought – correctly - that we would be able to sign other semi-exclusive licensees in a short time, as happened to be the case with Inverness, another giant in the industry.
(c) We had very preliminary yet very exciting results indicating that we can destroy cancer cells exhibiting RECAF on their surface without damaging healthy cells, which do not have RECAF. It is impossible to tackle that kind of project with the fund reserves we had before we secured the $3M from Centercourt.
The derailing of the GE purchase of Abbott Diagnostics and more importantly, the advent of an economic recession of this proportion was obviously not predictable. These facts, together with the very positive development of ELISA-RECAF tests that can be done in any clinical lab anywhere in the world; has changed our strategy: We are now devoting practically all of our resources to commercializing the RECAF blood tests as described below. Once we feel comfortable, we’ll go back to our work on the therapeutic side.
3. When will we see commercialization in RECAF and where? US or outside the US?
Here is what we are doing:
a) We are researching the 510K approval of another company’s product called DR70 by the US FDA. Everyone we contacted in the industry is surprised at this approval because of the loose use of the term “equivalence”. The applicants used CEA as an equivalent for another marker, which is something very unusual. In any case, this creates a precedent that could be useful for BioCurex.
b) In addition, the RECAF tests can be sold “for research purposes only”, with no FDA approval required and they can also be carried out, without FDA approval, as a ‘home brew test’ by accredited laboratories in the USA. We are exploring these possibilities; but we do not have any concrete information to provide at this time. Also, our licensees have the appropriate staff, network and procedures to accomplish it efficiently.
We are cruising in turbulent waters; Ford has announced its worst quarter in history and GM shares have lost 2/3 of their value in the last 6 months. The Dow has fallen from 14,000 points in October to less than 11,000 this month. We are not immune to this process. We have once come out of worse conditions than this situation. We did not panic, nor did we despair; we had no time for that. AND, we did not ask the Federal Reserve to bail us out! We have amazing technology and the ability to accomplish our mission of reducing human suffering. Patience and persistence is the key. We’ll just have to weather this storm.
Ricardo Moro.
