Opportunity stated: "Dr Moro you know you have adequate data to present to the FDA"
No that is not correct. Moro has absolutely ZERO data that would be acceptable for FDA device approval. Clinical trials run by an approved FDA facility would be needed. Moro CANNOT run the trial himself.
Moro had previously been stating that RECAF had undergone "clinical trials". Last year, that statement was challenged by the SEC and Moro changed the wording to "clinical studies".
If Moro began trials right now for FDA approval to monitor colon cancer, if he uses DR70 as a predicate, he would be required to accomplish serial testing on the same patient over a period of time. That is going to take time, lots of time and as the CEO of RPC stated, obtaining FDA approval was expensive and the approval is expensive to maintain.
IMO, self marketing of even an approved FDA device is not easy. RPC cannot get any significant sales of their approved test. Opportunity, you have to have money to market and Moro does not have money to do much of anything. That is why a licensee is so important and both licensees for RECAF seem to be in absentia.
At this point, decisions need to be made and Moro needs to obtain more funding. According to the Taglich analyst, Moro will be out of money in 9 months. Dog RECAF is not selling well so why invest in a Dog RECAF POC device. That was supposed to be completed by mid year so he has obviously delayed that program.
As stated in the filings, a positive result from a less accurate human POC device would have to be confirmed by the more accurate lab test. Big problem, no one is doing the more accurate lab test so what is the point of doing a human POC device right now? NONE.
Inverness/Alere was the last big hope for this stock and they appear to not even be willing to communicate with Moro any more. Alere shows nothing in their pipeline with RECAF and the enhanced PSA test that first appeared in the pipeline in 2008 was dropped from the investor presentations in April 2009. That is very close to the date that Moro said was the last communication from Alere.
I don't know if Moro will cut some deal with Alere like he did with Abbott to prevent a return but the fact is that Moro violated the Inverness contract by giving Abbott a deal with zero minimum royalties. Alere has 30 days from now to return RECAF or they could be obligated to pay minimum royalties.