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DewDiligence

04/21/13 4:18 PM

#160140 RE: mcbio #160120

You posted…about the potential for EXAS to refine its test to improve commercial prospects. How long do you think that work would take?

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.