Opportunity, if Moro does seek FDA approval, he could go with several options. He could conduct clinical trials to show that RECAF was substantially equivalent to CEA for colorectal cancer.
He could conduct clinical trials to show that RECAF was substantially equivalent to CA125 for ovarian cancer.
Both CA 15-3 and CA 27.29 have received FDA approval for serial monitoring patients with advanced breast cancer.
He could conduct clinical trials to show that RECAF was substantially equivalent to the above two markers for breast cancer.
All of the approvals would probably require serial monitoring. Serial monitoring means to repeatedly test over a period of time looking for an increased level of the marker.
The serial monitoring is what makes the trials more expensive and takes longer to amass the data.
If Moro attained FDA approval, he would then have to displace the other current markers that are being used by doctors or prove to the medical community that RECAF would be a BETTER option than the other tests. That takes time and money that Moro does not have.
So the queston begs. Do you put the cart before the horse and attempt approval without a partner and maybe not even get a partner AFTER approval?
Or do you concentrate on getting a partner with money that could attain FDA approval AND effectively market the product.
From the latest filings, I think Moro has chosen the second route.
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