Read update again. April is the expected FDA feedback on 2nd IDE draft. After that they plan to submit a "final draft" (stupid for MK to write that. Nobody knows if the expected third draft is last draft until FDA feedback received) that includes animal test results. In any case, a draft isn't an IDE application. A draft submitted to FDA is something one wants FDA feedback on before submitting the application for FDA consideration. We've known since MK's bogus 2nd 2021 IDE submission forecast that a draft IDE submission isn't an IDE application.
Looks like many steps and at least months to go before IDE submission. And that assumes FDA feedback on "final draft" submission concludes with green light for IDE submission.
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