Skipping steps. Don't even have the 2nd draft IDE feedback yet; that's expected next month. Then the plan is a "final draft" IDE application with animal test results, not an IDE application. Gotta get FDA feedback on that "final draft" that hopefully includes a green light for IDE application submission. A draft is not an IDE application. Submission looks a few months off at best. All depends on FDA feedback. Pre-submission discussions end when FDA says so, not before.
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