I concur with your response. I have no doubts about the companies ability to take it to market and also get it through the FDA. I simply stated this will be a First Diagnostic test the company has ever applied for. Some of the people on this board are stuck on John Howell and are missing the point.If people due their DD . Arrayit has work with the Government and has government contract and sales of its products to the Government. Since this is a INVITRO DIAGNOSTIC test it and qualifies for fast-track status for UNMET MEDICAL NEED. This will no doubt fly through the FDA, no problem, no matter who is in charge of the diagnostics division. They (FDA)are grading the TEST; grading the Efficacy of the test; not the person or company that submits it. Which, JMHO I would have to say must be stellar. If both Wayne State and the public Company (ARYC) are announcing it the world.JMHO
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