BioCurex, Inc.(fka BOCX)

[Gold Seeker]

Opportunity, I think you are getting a little ahead of your self about the FDA. There are two things they are going to have to prove to get approval from the FDA.

First, It must be proven that the test can detect cancer.

Second, It must be proven that the test can be run with duplicate samples by anyone, anywhere and get similar results. That is not just proving the test but proving that it can be accurately run on an analyzer.

Since only a few months ago, Dr. Moro said the test was completed except for some minor details, I would not anticipate any FDA tests so far. In addition, I would anticipate those trials to take about 4 to 5 months. After the trials are completed, the PMA would take a couple of months to assemble for FDA submission. I am not sure the current timeframe for device approval from the FDA but they are not greased lightning. I would give that up to 6 months. So add all that up and we have the test ready for market about this time next year.

Given the fact that previous payments from Abbott have not been significant, you can see why Dr. Moro opted for the larger financing package. We have a years worth of expenses, 2 million, plus burn until royalties arrive and the extra expenses of therapeutics.

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http://www.fda.gov/cdrh/devadvice/3122.html

In vitro diagnostics (IVD)


IVDs are medical devices that analyze human body fluids, such as blood or urine, to provide information for the diagnosis, prevention, or treatment of a disease. The device classification for these devices can be found under 21 CFR 862, 21 CFR 864, and 21 CFR 866.


FDA regulations provide 180 days to review the PMA and make a determination. In reality, the review time is normally longer. Before approving or denying a PMA, the appropriate FDA advisory committee may review the PMA at a public meeting and provide FDA with the committee's recommendation on whether FDA should approve the submission. After FDA notifies the applicant that the PMA has been approved or denied, a notice is published on the Internet (1) announcing the data on which the decision is based, and (2) providing interested persons an opportunity to petition FDA within 30 days for reconsideration of the decision.