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mcbio

04/21/13 4:22 PM

#160141 RE: DewDiligence #160140

EXAS

It would take at least 3-4 years, IMO, to: i) improve the suite of assays and the positive/negative algorithm; ii) validate the new system in animals and/or small human trials; iii) conduct a new phase-3 trial with powering similar to DeeP-C. (Note that DeeP-C, which had 10,000 patients, took two years to complete.)

Adding in time for preparing the new PMA and the FDA review, it would be about five years before a new version of the test could be on the market.

Thanks DD. I've never invested in a diagnostics company before and I'm not compelled to start here. ; )