Opportunity stated: "I am sorry you do not understand the protocols required to have a new marker approved"
I understand very well what is needed to obtain approval for a medical device.
FYI, NOTHING that has been EVER ben done with RECAF would be included in an application for FDA approval. No clinical trials have ever been conducted for RECAF.
Studies are just studies and results vary. If you look at the prostate study done in 2004, RECAF supposedly had 94% sensitivity and 100% specificity. That was just prior to signing Abbott. Eighteen months later, another study on prostate cancer showed sensitivity as low as 68%. WOW, what a huge difference.
Which of those studies was accurate? One study was already completed, why was another study done AFTER signing Abbott? If Abbott signed based on the first study of 94% sensitivity and no false positives, what do you think was their reaction to the results of the second study with results as low as 68% sensitivity and even at that low sensitivity, the test had false positives. Do you think Abbott was happy about the second results?
