Interview with Dr. Lou Vaickus, Tolerx, Question 7
DJ: What is the anticipated timeline for commercialization if all goes well?
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LV: We plan to submit all of our results to FDA (and afterwards to other regulatory agencies in Europe and elsewhere) at the end of 2012. The review of these results can be as short as 6-10 months or as long as 12-15 months before we hear whether our application is acceptable or not. If it's approved, then we can begin marketing our product as a safe and effective treatment to preserve insulin production in patients with recently diagnosed Type 1 diabetes.
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