Moro has nothing left but cat RECAF to hype. He had the PRE IDE meeting with the FDA and they obviously did not give him any kind of good news. In the update he recently gave to investors, Moro merely said that he had a meeting with the FDA and went on to talk about breast cancer monitoring and nothing more about the meeting.
"In October 2011, the Company submitted scientific information and a request for a meeting regarding an Investigational Device Exemption (IDE) to the Food and Drug Administration for the use of RECAF in conjunction with PSA to decrease the number of unnecessary prostate biopsies."
That's it folks! That was Moro's total comment on the meeting. NADA, NOTHING AT ALL.
Moro went on blowing smoke to make you think something else was discussed but it was not even part of the PRE IDE meeting discussions. He just made comments about monitoring as he has many time before.
"In addition, the RECAF technology could be used for monitoring recurrence of breast cancers for which there are no effective markers. The predicates for a 510K application would be CEA and CA.15.3 which are routinely used. CEA and CA15.3 are elevated in only 40-50% and 50-70%, respectively, of patients with distant metastases (with 5% false positives). At the same false positive rate, RECAF detects breast cancer in approximately 93% of breast cancers.
Moro's press rleases are all about pulling the wool over your eyes.
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